Trial Outcomes & Findings for MINDSpeed Food and Brain Training RCT (NCT NCT03419052)

NCT ID: NCT03419052

Last Updated: 2025-03-07

Results Overview

Executive Cognitive Function Composite Score as Measured by Individually-Administered Tests of Verbal Fluency, Complex Sequencing, Response Inhibition, and List Learning. The scale score range is -20 to 20. Low scores represent worse function and higher scores represent better function.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 212 participants
• Primary outcome timeframe: Immediately following the 12-week intervention (Immediate Post-Training)]
• Results posted on: 2025-03-07

Participant Flow

Enrolled participants were excluded from the study before group assignment when Baseline assessment or Tablet Orientation could not be completed.

Participant milestones

Measure	MINDSpeed Intervention Consumption of foods high in polyphenols (i.e., MIND foods) AND speed of processing training Speed of processing training: Speed of processing training is provided by the Internet-based BrainHQ program from Posit Science, Inc. BrainHQ contains five different speed training modules (Hawk Eye, Visual Sweeps, Fine Tuning, Eye for Detail, Sound Sweeps) which tap time-order judgment, visual discrimination, spatial-match, forward-span, instruction-following, and memory. MIND foods: The "MIND" diet (created by the Rush Aging \& Memory group) specifically emphasizes foods high in polyphenols such as berries, nuts, cocoa, black beans, olive oil, and green leafy vegetables. Participants select these foods from the digital study application and receive them through home delivery.	MIND Food and Training Control Consumption of foods high in polyphenols (i.e., MIND foods) AND online (inert) games MIND foods: The "MIND" diet (created by the Rush Aging \& Memory group) specifically emphasizes foods high in polyphenols such as berries, nuts, cocoa, black beans, olive oil, and green leafy vegetables. Participants select these foods from the digital study application and receive them through home delivery. Cognitive training control: Control training is provided by the Internet-based BrainHQ program from Posit Science, Inc.These are inert games such as tic-tac-toe, connect 4, battleship, etc.	Control Foods and Speed of Processing Training Consumption of low polyphenol foods AND speed of processing training Speed of processing training: Speed of processing training is provided by the Internet-based BrainHQ program from Posit Science, Inc. BrainHQ contains five different speed training modules (Hawk Eye, Visual Sweeps, Fine Tuning, Eye for Detail, Sound Sweeps) which tap time-order judgment, visual discrimination, spatial-match, forward-span, instruction-following, and memory. Control foods: Foods contain low polyphenols. Participants select these foods from the digital study application and receive them through home delivery.	Double Control Consumption of low polyphenol foods AND online (inert) games Cognitive training control: Control training is provided by the Internet-based BrainHQ program from Posit Science, Inc.These are inert games such as tic-tac-toe, connect 4, battleship, etc. Control foods: Foods contain low polyphenols. Participants select these foods from the digital study application and receive them through home delivery.
Immediate Post-Training STARTED	43	46	45	46
Immediate Post-Training COMPLETED	35	44	38	40
Immediate Post-Training NOT COMPLETED	8	2	7	6
Follow-Up STARTED	35	44	39	40
Follow-Up COMPLETED	33	39	38	35
Follow-Up NOT COMPLETED	2	5	1	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

MINDSpeed Food and Brain Training RCT

Baseline characteristics by cohort

Measure	MINDSpeed Intervention n=43 Participants Consumption of foods high in polyphenols (i.e., MIND foods) AND speed of processing training Speed of processing training: Speed of processing training is provided by the Internet-based BrainHQ program from Posit Science, Inc. BrainHQ contains five different speed training modules (Hawk Eye, Visual Sweeps, Fine Tuning, Eye for Detail, Sound Sweeps) which tap time-order judgment, visual discrimination, spatial-match, forward-span, instruction-following, and memory. MIND foods: The "MIND" diet (created by the Rush Aging \& Memory group) specifically emphasizes foods high in polyphenols such as berries, nuts, cocoa, black beans, olive oil, and green leafy vegetables. Participants select these foods from the digital study application and receive them through home delivery.	MIND Food and Training Control n=46 Participants Consumption of foods high in polyphenols (i.e., MIND foods) AND online (inert) games MIND foods: The "MIND" diet (created by the Rush Aging \& Memory group) specifically emphasizes foods high in polyphenols such as berries, nuts, cocoa, black beans, olive oil, and green leafy vegetables. Participants select these foods from the digital study application and receive them through home delivery. Cognitive training control: Control training is provided by the Internet-based BrainHQ program from Posit Science, Inc.These are inert games such as tic-tac-toe, connect 4, battleship, etc.	Control Foods and Speed of Processing Training n=45 Participants Consumption of low polyphenol foods AND speed of processing training Speed of processing training: Speed of processing training is provided by the Internet-based BrainHQ program from Posit Science, Inc. BrainHQ contains five different speed training modules (Hawk Eye, Visual Sweeps, Fine Tuning, Eye for Detail, Sound Sweeps) which tap time-order judgment, visual discrimination, spatial-match, forward-span, instruction-following, and memory. Control foods: Foods contain low polyphenols. Participants select these foods from the digital study application and receive them through home delivery.	Double Control n=46 Participants Consumption of low polyphenol foods AND online (inert) games Cognitive training control: Control training is provided by the Internet-based BrainHQ program from Posit Science, Inc.These are inert games such as tic-tac-toe, connect 4, battleship, etc. Control foods: Foods contain low polyphenols. Participants select these foods from the digital study application and receive them through home delivery.	Total n=180 Participants Total of all reporting groups
Age, Continuous	66.9 years STANDARD_DEVIATION 6.3 • n=5 Participants	65.0 years STANDARD_DEVIATION 4.7 • n=7 Participants	66.1 years STANDARD_DEVIATION 6.4 • n=5 Participants	65.6 years STANDARD_DEVIATION 5.1 • n=4 Participants	65.51 years STANDARD_DEVIATION 5.66 • n=21 Participants
Sex: Female, Male Female	31 Participants n=5 Participants	28 Participants n=7 Participants	28 Participants n=5 Participants	30 Participants n=4 Participants	117 Participants n=21 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	18 Participants n=7 Participants	17 Participants n=5 Participants	16 Participants n=4 Participants	63 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Black or African American	32 Participants n=5 Participants	32 Participants n=7 Participants	30 Participants n=5 Participants	25 Participants n=4 Participants	119 Participants n=21 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants	12 Participants n=7 Participants	12 Participants n=5 Participants	18 Participants n=4 Participants	53 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	5 Participants n=21 Participants
Region of Enrollment United States	43 Participants n=5 Participants	46 Participants n=7 Participants	45 Participants n=5 Participants	46 Participants n=4 Participants	180 Participants n=21 Participants

PRIMARY outcome

Timeframe: Immediately following the 12-week intervention (Immediate Post-Training)]

Executive Cognitive Function Composite Score as Measured by Individually-Administered Tests of Verbal Fluency, Complex Sequencing, Response Inhibition, and List Learning. The scale score range is -20 to 20. Low scores represent worse function and higher scores represent better function.

Outcome measures

Measure	MINDSpeed Intervention n=43 Participants Consumption of foods high in polyphenols (i.e., MIND foods) AND speed of processing training Speed of processing training: Speed of processing training is provided by the Internet-based BrainHQ program from Posit Science, Inc. BrainHQ contains five different speed training modules (Hawk Eye, Visual Sweeps, Fine Tuning, Eye for Detail, Sound Sweeps) which tap time-order judgment, visual discrimination, spatial-match, forward-span, instruction-following, and memory. MIND foods: The "MIND" diet (created by the Rush Aging \& Memory group) specifically emphasizes foods high in polyphenols such as berries, nuts, cocoa, black beans, olive oil, and green leafy vegetables. Participants select these foods from the digital study application and receive them through home delivery.	MIND Food and Training Control n=46 Participants Consumption of foods high in polyphenols (i.e., MIND foods) AND online (inert) games MIND foods: The "MIND" diet (created by the Rush Aging \& Memory group) specifically emphasizes foods high in polyphenols such as berries, nuts, cocoa, black beans, olive oil, and green leafy vegetables. Participants select these foods from the digital study application and receive them through home delivery. Cognitive training control: Control training is provided by the Internet-based BrainHQ program from Posit Science, Inc.These are inert games such as tic-tac-toe, connect 4, battleship, etc.	Control Foods and Speed of Processing Training n=45 Participants Consumption of low polyphenol foods AND speed of processing training Speed of processing training: Speed of processing training is provided by the Internet-based BrainHQ program from Posit Science, Inc. BrainHQ contains five different speed training modules (Hawk Eye, Visual Sweeps, Fine Tuning, Eye for Detail, Sound Sweeps) which tap time-order judgment, visual discrimination, spatial-match, forward-span, instruction-following, and memory. Control foods: Foods contain low polyphenols. Participants select these foods from the digital study application and receive them through home delivery.	Double Control n=46 Participants Consumption of low polyphenol foods AND online (inert) games Cognitive training control: Control training is provided by the Internet-based BrainHQ program from Posit Science, Inc.These are inert games such as tic-tac-toe, connect 4, battleship, etc. Control foods: Foods contain low polyphenols. Participants select these foods from the digital study application and receive them through home delivery.
Executive Cognitive Function Composite Score	0.211 units on a scale Interval 0.094 to 0.329	0.100 units on a scale Interval -0.005 to 0.204	0.142 units on a scale Interval 0.029 to 0.254	0.196 units on a scale Interval 0.086 to 0.306

Adverse Events

MINDSpeed Intervention

Serious events: 9 serious events

Other events: 3 other events

Deaths: 0 deaths

MIND Food and Training Control

Serious events: 18 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Foods and Speed of Processing Training

Serious events: 16 serious events

Other events: 0 other events

Deaths: 0 deaths

Double Control

Serious events: 21 serious events

Other events: 3 other events

Deaths: 1 deaths

Serious adverse events

Measure	MINDSpeed Intervention n=43 participants at risk Consumption of foods high in polyphenols (i.e., MIND foods) AND speed of processing training Speed of processing training: Speed of processing training is provided by the Internet-based BrainHQ program from Posit Science, Inc. BrainHQ contains five different speed training modules (Hawk Eye, Visual Sweeps, Fine Tuning, Eye for Detail, Sound Sweeps) which tap time-order judgment, visual discrimination, spatial-match, forward-span, instruction-following, and memory. MIND foods: The "MIND" diet (created by the Rush Aging \& Memory group) specifically emphasizes foods high in polyphenols such as berries, nuts, cocoa, black beans, olive oil, and green leafy vegetables. Participants select these foods from the digital study application and receive them through home delivery.	MIND Food and Training Control n=46 participants at risk Consumption of foods high in polyphenols (i.e., MIND foods) AND online (inert) games MIND foods: The "MIND" diet (created by the Rush Aging \& Memory group) specifically emphasizes foods high in polyphenols such as berries, nuts, cocoa, black beans, olive oil, and green leafy vegetables. Participants select these foods from the digital study application and receive them through home delivery. Cognitive training control: Control training is provided by the Internet-based BrainHQ program from Posit Science, Inc.These are inert games such as tic-tac-toe, connect 4, battleship, etc.	Control Foods and Speed of Processing Training n=45 participants at risk Consumption of low polyphenol foods AND speed of processing training Speed of processing training: Speed of processing training is provided by the Internet-based BrainHQ program from Posit Science, Inc. BrainHQ contains five different speed training modules (Hawk Eye, Visual Sweeps, Fine Tuning, Eye for Detail, Sound Sweeps) which tap time-order judgment, visual discrimination, spatial-match, forward-span, instruction-following, and memory. Control foods: Foods contain low polyphenols. Participants select these foods from the digital study application and receive them through home delivery.	Double Control n=46 participants at risk Consumption of low polyphenol foods AND online (inert) games Cognitive training control: Control training is provided by the Internet-based BrainHQ program from Posit Science, Inc.These are inert games such as tic-tac-toe, connect 4, battleship, etc. Control foods: Foods contain low polyphenols. Participants select these foods from the digital study application and receive them through home delivery.
Musculoskeletal and connective tissue disorders Arthritis	2.3% 1/43 • Number of events 1 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/46 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/45 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	2.2% 1/46 • Number of events 1 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.
Respiratory, thoracic and mediastinal disorders Asthma and bronchitis	2.3% 1/43 • Number of events 1 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/46 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/45 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/46 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.
Infections and infestations COVID	7.0% 3/43 • Number of events 3 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/46 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	4.4% 2/45 • Number of events 2 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	2.2% 1/46 • Number of events 1 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.
Infections and infestations Flu	2.3% 1/43 • Number of events 1 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/46 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/45 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/46 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.
Surgical and medical procedures Hysterectomy	2.3% 1/43 • Number of events 1 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/46 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	2.2% 1/45 • Number of events 1 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/46 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.
Cardiac disorders Mild heart attack	2.3% 1/43 • Number of events 1 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/46 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/45 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/46 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.
Infections and infestations Osteomyelitis	2.3% 1/43 • Number of events 1 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/46 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/45 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/46 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.
Blood and lymphatic system disorders Anemia	0.00% 0/43 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	2.2% 1/46 • Number of events 1 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/45 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/46 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.
Cardiac disorders Angina	0.00% 0/43 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	2.2% 1/46 • Number of events 1 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/45 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/46 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.
Injury, poisoning and procedural complications Assault	0.00% 0/43 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	2.2% 1/46 • Number of events 1 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/45 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/46 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.
Infections and infestations Cellulitis	0.00% 0/43 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	2.2% 1/46 • Number of events 1 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/45 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/46 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.
Respiratory, thoracic and mediastinal disorders COPD Exacerbation	0.00% 0/43 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	2.2% 1/46 • Number of events 1 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/45 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	2.2% 1/46 • Number of events 1 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.
General disorders Dehydration	0.00% 0/43 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	2.2% 1/46 • Number of events 1 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/45 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/46 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.
General disorders Frailty	0.00% 0/43 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	2.2% 1/46 • Number of events 1 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/45 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/46 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.
Musculoskeletal and connective tissue disorders Function loss from femur break	0.00% 0/43 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	2.2% 1/46 • Number of events 1 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/45 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/46 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.
Gastrointestinal disorders GI bleeding	0.00% 0/43 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	2.2% 1/46 • Number of events 1 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/45 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/46 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.
Surgical and medical procedures Hernia	0.00% 0/43 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	2.2% 1/46 • Number of events 1 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/45 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	2.2% 1/46 • Number of events 1 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.
Surgical and medical procedures Orthopedic surgery	0.00% 0/43 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	2.2% 1/46 • Number of events 1 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/45 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/46 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.
Respiratory, thoracic and mediastinal disorders Reactive airway disease	0.00% 0/43 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	2.2% 1/46 • Number of events 1 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/45 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/46 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.
Renal and urinary disorders Renal failure	0.00% 0/43 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	2.2% 1/46 • Number of events 1 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	2.2% 1/45 • Number of events 1 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/46 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.
Respiratory, thoracic and mediastinal disorders Shortness of breath	0.00% 0/43 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	2.2% 1/46 • Number of events 1 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	2.2% 1/45 • Number of events 1 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/46 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.
Infections and infestations Toe ulcer	0.00% 0/43 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	2.2% 1/46 • Number of events 1 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/45 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/46 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.
Vascular disorders Venous stasis ulcer	0.00% 0/43 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	2.2% 1/46 • Number of events 1 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/45 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/46 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.
Infections and infestations Viral illness	0.00% 0/43 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	2.2% 1/46 • Number of events 1 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/45 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/46 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/43 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/46 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	2.2% 1/45 • Number of events 1 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/46 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.
Cardiac disorders Chest pain	0.00% 0/43 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/46 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	2.2% 1/45 • Number of events 1 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/46 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.
Cardiac disorders CHF complication	0.00% 0/43 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/46 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	2.2% 1/45 • Number of events 1 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/46 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.
Injury, poisoning and procedural complications Fall	0.00% 0/43 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/46 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	2.2% 1/45 • Number of events 1 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	2.2% 1/46 • Number of events 1 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.
Injury, poisoning and procedural complications Laceration	0.00% 0/43 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/46 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	2.2% 1/45 • Number of events 1 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/46 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.
Surgical and medical procedures Kidney mass	0.00% 0/43 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/46 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	2.2% 1/45 • Number of events 1 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/46 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.
Surgical and medical procedures Knee surgery	0.00% 0/43 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/46 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	4.4% 2/45 • Number of events 2 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/46 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.
Cardiac disorders Myocardial infarction rule out	0.00% 0/43 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/46 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	2.2% 1/45 • Number of events 1 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/46 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.
Renal and urinary disorders Urinary track infection	0.00% 0/43 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/46 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	4.4% 2/45 • Number of events 2 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/46 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.
Surgical and medical procedures Breast cancer	0.00% 0/43 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/46 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/45 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	2.2% 1/46 • Number of events 1 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.
Surgical and medical procedures Bunion	0.00% 0/43 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/46 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/45 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	2.2% 1/46 • Number of events 1 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.
Musculoskeletal and connective tissue disorders Carpal tunnel	0.00% 0/43 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/46 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/45 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	2.2% 1/46 • Number of events 1 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.
Reproductive system and breast disorders Cysts	0.00% 0/43 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/46 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/45 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	2.2% 1/46 • Number of events 1 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.
Gastrointestinal disorders Diverticulitis	0.00% 0/43 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/46 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/45 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	2.2% 1/46 • Number of events 1 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.
Gastrointestinal disorders Diverticulosis	0.00% 0/43 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/46 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/45 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	2.2% 1/46 • Number of events 1 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.
Respiratory, thoracic and mediastinal disorders Lung disease	0.00% 0/43 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/46 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/45 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	4.3% 2/46 • Number of events 2 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.
General disorders Mobility issues	0.00% 0/43 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/46 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/45 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	2.2% 1/46 • Number of events 1 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.
Musculoskeletal and connective tissue disorders Muscle pain	0.00% 0/43 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/46 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/45 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	2.2% 1/46 • Number of events 1 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.
General disorders Nursing home placement	0.00% 0/43 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/46 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/45 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	2.2% 1/46 • Number of events 1 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.
General disorders Oral pain	0.00% 0/43 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/46 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/45 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	2.2% 1/46 • Number of events 1 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/43 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/46 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/45 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	2.2% 1/46 • Number of events 1 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.
Infections and infestations Sinus infection	0.00% 0/43 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/46 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/45 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	2.2% 1/46 • Number of events 1 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.
Infections and infestations Upper respiratory infection	0.00% 0/43 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/46 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/45 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	2.2% 1/46 • Number of events 1 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.
Product Issues Vaccine reaction	0.00% 0/43 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/46 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/45 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	2.2% 1/46 • Number of events 1 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.
Cardiac disorders Myocardial infarction	0.00% 0/43 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	2.2% 1/46 • Number of events 1 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/45 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/46 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.

Other adverse events

Measure	MINDSpeed Intervention n=43 participants at risk Consumption of foods high in polyphenols (i.e., MIND foods) AND speed of processing training Speed of processing training: Speed of processing training is provided by the Internet-based BrainHQ program from Posit Science, Inc. BrainHQ contains five different speed training modules (Hawk Eye, Visual Sweeps, Fine Tuning, Eye for Detail, Sound Sweeps) which tap time-order judgment, visual discrimination, spatial-match, forward-span, instruction-following, and memory. MIND foods: The "MIND" diet (created by the Rush Aging \& Memory group) specifically emphasizes foods high in polyphenols such as berries, nuts, cocoa, black beans, olive oil, and green leafy vegetables. Participants select these foods from the digital study application and receive them through home delivery.	MIND Food and Training Control n=46 participants at risk Consumption of foods high in polyphenols (i.e., MIND foods) AND online (inert) games MIND foods: The "MIND" diet (created by the Rush Aging \& Memory group) specifically emphasizes foods high in polyphenols such as berries, nuts, cocoa, black beans, olive oil, and green leafy vegetables. Participants select these foods from the digital study application and receive them through home delivery. Cognitive training control: Control training is provided by the Internet-based BrainHQ program from Posit Science, Inc.These are inert games such as tic-tac-toe, connect 4, battleship, etc.	Control Foods and Speed of Processing Training n=45 participants at risk Consumption of low polyphenol foods AND speed of processing training Speed of processing training: Speed of processing training is provided by the Internet-based BrainHQ program from Posit Science, Inc. BrainHQ contains five different speed training modules (Hawk Eye, Visual Sweeps, Fine Tuning, Eye for Detail, Sound Sweeps) which tap time-order judgment, visual discrimination, spatial-match, forward-span, instruction-following, and memory. Control foods: Foods contain low polyphenols. Participants select these foods from the digital study application and receive them through home delivery.	Double Control n=46 participants at risk Consumption of low polyphenol foods AND online (inert) games Cognitive training control: Control training is provided by the Internet-based BrainHQ program from Posit Science, Inc.These are inert games such as tic-tac-toe, connect 4, battleship, etc. Control foods: Foods contain low polyphenols. Participants select these foods from the digital study application and receive them through home delivery.
Injury, poisoning and procedural complications Fall	7.0% 3/43 • Number of events 3 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/46 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/45 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/46 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.
Respiratory, thoracic and mediastinal disorders Shortness of breath	0.00% 0/43 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/46 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	0.00% 0/45 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.	6.5% 3/46 • Number of events 3 • Adverse events were collected from time of study enrollment (i.e., informed consent) until the participant completed the study at 6-Month Follow-Up or withdrew from the study, whichever came first. Participants were asked specifically about adverse events through structured questionnaire at Immediate Post-Training and Follow-Up study visits, though events were reported throughout the adverse event time frame as they became known to study staff.

Additional Information

Daniel Clark, PhD

Indiana University

Phone: 317-274-9292

Email: daniclar@iu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place