Trial Outcomes & Findings for Promoting Recovery Optimization With WALKing Exercise After Stroke (NCT NCT02835313)

NCT ID: NCT02835313

Last Updated: 2024-10-28

Results Overview

average change in steps per day between two time points, measured over at least a 3-day period for each time point

Recruitment status

COMPLETED

Study phase

Target enrollment

250 participants

Primary outcome timeframe

Change from Baseline to 3 months (Post)

Results posted on

2024-10-28

Participant Flow

Participant milestones

Participant milestones
Measure	FAST+SAM Subjects participate in fast walking training in combination with a step activity monitoring program FAST+SAM: Subjects participate in fast walking training plus a step activity monitoring program 3x/week for 12 weeks	FAST Alone Subjects participate in fast walking training FAST: Subjects participate in fast walking training 3x/week for 12 weeks.	SAM Alone Subjects participate in a step activity monitoring program SAM: Subjects participate in a step activity monitoring program 3x/week for 12 weeks.
Overall Study STARTED	80	89	81
Overall Study Completed POST (3-month)	63	69	68
Overall Study Completed 6-month	62	68	58
Overall Study Completed 12-month	48	64	49
Overall Study COMPLETED	48	64	49
Overall Study NOT COMPLETED	32	25	32

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Promoting Recovery Optimization With WALKing Exercise After Stroke

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FAST+SAM n=80 Participants Subjects participate in fast walking training in combination with a step activity monitoring program FAST+SAM: Subjects participate in fast walking training plus a step activity monitoring program 3x/week for 12 weeks	FAST Alone n=89 Participants Subjects participate in fast walking training FAST: Subjects participate in fast walking training 3x/week for 12 weeks.	SAM Alone n=81 Participants Subjects participate in a step activity monitoring program SAM: Subjects participate in a step activity monitoring program 3x/week for 12 weeks	Total n=250 Participants Total of all reporting groups
Age, Continuous	62 years STANDARD_DEVIATION 13.07 • n=5 Participants	63 years STANDARD_DEVIATION 11.96 • n=7 Participants	62 years STANDARD_DEVIATION 12.91 • n=5 Participants	63 years STANDARD_DEVIATION 12.61 • n=4 Participants
Sex: Female, Male Female	36 Participants n=5 Participants	41 Participants n=7 Participants	39 Participants n=5 Participants	116 Participants n=4 Participants
Sex: Female, Male Male	44 Participants n=5 Participants	48 Participants n=7 Participants	42 Participants n=5 Participants	134 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	5 Participants n=7 Participants	2 Participants n=5 Participants	10 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	77 Participants n=5 Participants	84 Participants n=7 Participants	79 Participants n=5 Participants	240 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized American Indian or Alaskan Native	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Asian	4 Participants n=5 Participants	7 Participants n=7 Participants	2 Participants n=5 Participants	13 Participants n=4 Participants
Race/Ethnicity, Customized Native Hawaiian or Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized Black or African American	20 Participants n=5 Participants	20 Participants n=7 Participants	26 Participants n=5 Participants	66 Participants n=4 Participants
Race/Ethnicity, Customized White	49 Participants n=5 Participants	55 Participants n=7 Participants	48 Participants n=5 Participants	152 Participants n=4 Participants
Race/Ethnicity, Customized More than one race	6 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	16 Participants n=4 Participants
Race/Ethnicity, Customized Unknown or not reported	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Region of Enrollment United States	80 participants n=5 Participants	89 participants n=7 Participants	81 participants n=5 Participants	250 participants n=4 Participants
Time since stroke	42 months STANDARD_DEVIATION 48.75 • n=5 Participants	46 months STANDARD_DEVIATION 62.25 • n=7 Participants	46 months STANDARD_DEVIATION 73.22 • n=5 Participants	45 months STANDARD_DEVIATION 62.04 • n=4 Participants
Body mass index	30.13 kg/m^2 STANDARD_DEVIATION 5.45 • n=5 Participants	29.79 kg/m^2 STANDARD_DEVIATION 6.39 • n=7 Participants	31.58 kg/m^2 STANDARD_DEVIATION 7.05 • n=5 Participants	30.48 kg/m^2 STANDARD_DEVIATION 6.35 • n=4 Participants
Side of hemiparesis Left	39 Participants n=5 Participants	43 Participants n=7 Participants	42 Participants n=5 Participants	124 Participants n=4 Participants
Side of hemiparesis Right	37 Participants n=5 Participants	43 Participants n=7 Participants	34 Participants n=5 Participants	114 Participants n=4 Participants
Side of hemiparesis Both affected	4 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	12 Participants n=4 Participants
Ambulatory assistive device use	36 Participants n=5 Participants	46 Participants n=7 Participants	47 Participants n=5 Participants	129 Participants n=4 Participants
Lower extremity orthotic use	22 Participants n=5 Participants	21 Participants n=7 Participants	25 Participants n=5 Participants	68 Participants n=4 Participants
Steps per day	3768 steps/day STANDARD_DEVIATION 2074 • n=5 Participants	3959 steps/day STANDARD_DEVIATION 2021 • n=7 Participants	3845 steps/day STANDARD_DEVIATION 2193 • n=5 Participants	3861 steps/day STANDARD_DEVIATION 2088 • n=4 Participants
Six-minute walk test distance	283 meters STANDARD_DEVIATION 122 • n=5 Participants	296 meters STANDARD_DEVIATION 113 • n=7 Participants	279 meters STANDARD_DEVIATION 110 • n=5 Participants	287 meters STANDARD_DEVIATION 115 • n=4 Participants
Self-selected gait speed	0.68 meters/sec STANDARD_DEVIATION 0.22 • n=5 Participants	0.71 meters/sec STANDARD_DEVIATION 0.20 • n=7 Participants	0.68 meters/sec STANDARD_DEVIATION 0.22 • n=5 Participants	0.69 meters/sec STANDARD_DEVIATION 0.21 • n=4 Participants
VO2 at ventilatory threshold	9.63 mL/kg per min STANDARD_DEVIATION 3.35 • n=5 Participants	8.77 mL/kg per min STANDARD_DEVIATION 2.98 • n=7 Participants	9.37 mL/kg per min STANDARD_DEVIATION 2.66 • n=5 Participants	9.24 mL/kg per min STANDARD_DEVIATION 3.02 • n=4 Participants

PRIMARY outcome

Timeframe: Change from Baseline to 3 months (Post)

average change in steps per day between two time points, measured over at least a 3-day period for each time point

Outcome measures

Outcome measures
Measure	FAST+SAM n=80 Participants Subjects participate in fast walking training in combination with a step activity monitoring program FAST+SAM: Subjects participate in fast walking training plus a step activity monitoring program 3x/week for 12 weeks	FAST Alone n=89 Participants Subjects participate in fast walking training FAST: Subjects participate in fast walking training 3x/week for 12 weeks.	SAM Alone n=81 Participants Subjects participate in a step activity monitoring program SAM: Subjects participate in a step activity monitoring program 3x/week for 12 weeks.
Steps Per Day	1307 steps per day Interval 752.0 to 1861.0	406 steps per day Interval -63.0 to 876.0	1542 steps per day Interval 1014.0 to 2069.0

PRIMARY outcome

Timeframe: Change from 3 months (Post) to 6 months

average change in steps per day between two time points, measured over at least a 3-day period for each time point

Outcome measures

Outcome measures
Measure	FAST+SAM n=63 Participants Subjects participate in fast walking training in combination with a step activity monitoring program FAST+SAM: Subjects participate in fast walking training plus a step activity monitoring program 3x/week for 12 weeks	FAST Alone n=69 Participants Subjects participate in fast walking training FAST: Subjects participate in fast walking training 3x/week for 12 weeks.	SAM Alone n=68 Participants Subjects participate in a step activity monitoring program SAM: Subjects participate in a step activity monitoring program 3x/week for 12 weeks.
Steps Per Day	-400 steps per day Interval -990.0 to 190.0	-160 steps per day Interval -697.0 to 376.0	-1016 steps per day Interval -1546.0 to -485.0

PRIMARY outcome

Timeframe: Change from 3 months (Post) to 12 months

average change in steps per day between two time points, measured over at least a 3-day period for each time point

Outcome measures

Outcome measures
Measure	FAST+SAM n=63 Participants Subjects participate in fast walking training in combination with a step activity monitoring program FAST+SAM: Subjects participate in fast walking training plus a step activity monitoring program 3x/week for 12 weeks	FAST Alone n=69 Participants Subjects participate in fast walking training FAST: Subjects participate in fast walking training 3x/week for 12 weeks.	SAM Alone n=68 Participants Subjects participate in a step activity monitoring program SAM: Subjects participate in a step activity monitoring program 3x/week for 12 weeks.
Steps Per Day	-568 steps per day Interval -1185.0 to 48.0	-610 steps per day Interval -1162.0 to -59.0	-1072 steps per day Interval -1675.0 to -469.0

SECONDARY outcome

Timeframe: Change from Baseline to 3 months (Post)

change between two time points in endurance (measured by distance attained on the 6 minute walk test)

Outcome measures

Outcome measures
Measure	FAST+SAM n=80 Participants Subjects participate in fast walking training in combination with a step activity monitoring program FAST+SAM: Subjects participate in fast walking training plus a step activity monitoring program 3x/week for 12 weeks	FAST Alone n=89 Participants Subjects participate in fast walking training FAST: Subjects participate in fast walking training 3x/week for 12 weeks.	SAM Alone n=81 Participants Subjects participate in a step activity monitoring program SAM: Subjects participate in a step activity monitoring program 3x/week for 12 weeks.
Six-minute Walk Test Distance	39 meters Interval 23.0 to 56.0	43 meters Interval 32.0 to 54.0	25 meters Interval 13.0 to 36.0

SECONDARY outcome

Timeframe: Change from 3 months (Post) to 6 months

change between two time points in endurance (measured by distance attained on the 6 minute walk test)

Outcome measures

Outcome measures
Measure	FAST+SAM n=63 Participants Subjects participate in fast walking training in combination with a step activity monitoring program FAST+SAM: Subjects participate in fast walking training plus a step activity monitoring program 3x/week for 12 weeks	FAST Alone n=69 Participants Subjects participate in fast walking training FAST: Subjects participate in fast walking training 3x/week for 12 weeks.	SAM Alone n=68 Participants Subjects participate in a step activity monitoring program SAM: Subjects participate in a step activity monitoring program 3x/week for 12 weeks.
Six-minute Walk Test Distance	-13 meters Interval -24.0 to -2.0	-10 meters Interval -21.0 to -1.0	-15 meters Interval -30.0 to 1.0

SECONDARY outcome

Timeframe: Change from 3 months (Post) to 12 months

change between two time points in endurance (measured by distance attained on the 6 minute walk test)

Outcome measures

Outcome measures
Measure	FAST+SAM n=63 Participants Subjects participate in fast walking training in combination with a step activity monitoring program FAST+SAM: Subjects participate in fast walking training plus a step activity monitoring program 3x/week for 12 weeks	FAST Alone n=69 Participants Subjects participate in fast walking training FAST: Subjects participate in fast walking training 3x/week for 12 weeks.	SAM Alone n=68 Participants Subjects participate in a step activity monitoring program SAM: Subjects participate in a step activity monitoring program 3x/week for 12 weeks.
Six-minute Walk Test Distance	-18 meters Interval -32.0 to -3.0	-21 meters Interval -33.0 to -9.0	-16 meters Interval -32.0 to 1.0

SECONDARY outcome

Timeframe: Change from Baseline to 3 months (Post)

change between two time points in average self-selected speed on the 10m walk test

Outcome measures

Outcome measures
Measure	FAST+SAM n=80 Participants Subjects participate in fast walking training in combination with a step activity monitoring program FAST+SAM: Subjects participate in fast walking training plus a step activity monitoring program 3x/week for 12 weeks	FAST Alone n=89 Participants Subjects participate in fast walking training FAST: Subjects participate in fast walking training 3x/week for 12 weeks.	SAM Alone n=81 Participants Subjects participate in a step activity monitoring program SAM: Subjects participate in a step activity monitoring program 3x/week for 12 weeks.
Self-selected Gait Speed	0.14 meters/sec Interval 0.1 to 0.17	0.13 meters/sec Interval 0.1 to 0.17	0.11 meters/sec Interval 0.08 to 0.14

SECONDARY outcome

Timeframe: Change from 3 months (Post) to 6 months

change between two time points in average self-selected speed on the 10m walk test

Outcome measures

Outcome measures
Measure	FAST+SAM n=63 Participants Subjects participate in fast walking training in combination with a step activity monitoring program FAST+SAM: Subjects participate in fast walking training plus a step activity monitoring program 3x/week for 12 weeks	FAST Alone n=69 Participants Subjects participate in fast walking training FAST: Subjects participate in fast walking training 3x/week for 12 weeks.	SAM Alone n=68 Participants Subjects participate in a step activity monitoring program SAM: Subjects participate in a step activity monitoring program 3x/week for 12 weeks.
Self-selected Gait Speed	-0.02 meters/sec Interval -0.05 to 0.01	-0.03 meters/sec Interval -0.06 to 0.01	-0.02 meters/sec Interval -0.05 to 0.01

SECONDARY outcome

Timeframe: Change from 3 months (Post) to 12 months

change between two time points in average self-selected speed on the 10m walk test

Outcome measures

Outcome measures
Measure	FAST+SAM n=63 Participants Subjects participate in fast walking training in combination with a step activity monitoring program FAST+SAM: Subjects participate in fast walking training plus a step activity monitoring program 3x/week for 12 weeks	FAST Alone n=69 Participants Subjects participate in fast walking training FAST: Subjects participate in fast walking training 3x/week for 12 weeks.	SAM Alone n=68 Participants Subjects participate in a step activity monitoring program SAM: Subjects participate in a step activity monitoring program 3x/week for 12 weeks.
Self-selected Gait Speed	-0.02 meters/sec Interval -0.05 to 0.02	-0.05 meters/sec Interval -0.07 to -0.02	-0.04 meters/sec Interval -0.08 to 0.01

SECONDARY outcome

Timeframe: Change from Baseline to 3 months (Post)

change between two time points in average oxygen consumption at ventilatory threshold

Outcome measures

Outcome measures
Measure	FAST+SAM n=80 Participants Subjects participate in fast walking training in combination with a step activity monitoring program FAST+SAM: Subjects participate in fast walking training plus a step activity monitoring program 3x/week for 12 weeks	FAST Alone n=89 Participants Subjects participate in fast walking training FAST: Subjects participate in fast walking training 3x/week for 12 weeks.	SAM Alone n=81 Participants Subjects participate in a step activity monitoring program SAM: Subjects participate in a step activity monitoring program 3x/week for 12 weeks.
Oxygen Consumption	0.31 mL/kg/min Interval -0.52 to 1.13	0.27 mL/kg/min Interval -1.05 to 0.5	0.01 mL/kg/min Interval -0.73 to 0.71

SECONDARY outcome

Timeframe: Change from 3 months (Post) to 6 months

change between two time points in average oxygen consumption at ventilatory threshold

Outcome measures

Outcome measures
Measure	FAST+SAM n=63 Participants Subjects participate in fast walking training in combination with a step activity monitoring program FAST+SAM: Subjects participate in fast walking training plus a step activity monitoring program 3x/week for 12 weeks	FAST Alone n=69 Participants Subjects participate in fast walking training FAST: Subjects participate in fast walking training 3x/week for 12 weeks.	SAM Alone n=68 Participants Subjects participate in a step activity monitoring program SAM: Subjects participate in a step activity monitoring program 3x/week for 12 weeks.
Oxygen Consumption	-0.32 mL/kg/min Interval -1.0 to 0.36	-0.53 mL/kg/min Interval -1.28 to 0.23	0.13 mL/kg/min Interval -0.38 to 0.65

SECONDARY outcome

Timeframe: Change from 3 months (Post) to 12 months

change between two time points in average oxygen consumption at ventilatory threshold

Outcome measures

Outcome measures
Measure	FAST+SAM n=63 Participants Subjects participate in fast walking training in combination with a step activity monitoring program FAST+SAM: Subjects participate in fast walking training plus a step activity monitoring program 3x/week for 12 weeks	FAST Alone n=69 Participants Subjects participate in fast walking training FAST: Subjects participate in fast walking training 3x/week for 12 weeks.	SAM Alone n=68 Participants Subjects participate in a step activity monitoring program SAM: Subjects participate in a step activity monitoring program 3x/week for 12 weeks.
Oxygen Consumption	-0.08 mL/kg/min Interval -1.01 to 0.86	-1.32 mL/kg/min Interval -2.06 to -0.59	-0.15 mL/kg/min Interval -0.95 to 0.66

Adverse Events

FAST+SAM

Serious events: 14 serious events

Other events: 25 other events

Deaths: 0 deaths

FAST Alone

Serious events: 9 serious events

Other events: 38 other events

Deaths: 1 deaths

SAM Alone

Serious events: 3 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	FAST+SAM n=80 participants at risk Subjects participate in fast walking training in combination with a step activity monitoring program FAST+SAM: Subjects participate in fast walking training plus a step activity monitoring program 3x/week for 12 weeks	FAST Alone n=89 participants at risk Subjects participate in fast walking training FAST: Subjects participate in fast walking training 3x/week for 12 weeks.	SAM Alone n=81 participants at risk Subjects participate in a step activity monitoring program SAM: Subjects participate in a step activity monitoring program 3x/week for 12 weeks.
Nervous system disorders Recurrent Stroke (Randomization-Post)	0.00% 0/80 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.	0.00% 0/89 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.	0.00% 0/81 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.
Cardiac disorders Myocardial Infarction (Randomization-Post)	0.00% 0/80 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.	0.00% 0/89 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.	0.00% 0/81 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.
Musculoskeletal and connective tissue disorders Fracture (Randomization-Post)	0.00% 0/80 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.	1.1% 1/89 • Number of events 1 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.	0.00% 0/81 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.
General disorders Hospitalization (Randomization-Post)	7.5% 6/80 • Number of events 6 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.	3.4% 3/89 • Number of events 3 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.	1.2% 1/81 • Number of events 1 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.
General disorders Death (Randomization-Post)	0.00% 0/80 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.	0.00% 0/89 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.	0.00% 0/81 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.
General disorders Significant incapacity to perform ADLs for >48 hrs (Randomization-Post)	0.00% 0/80 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.	0.00% 0/89 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.	0.00% 0/81 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.
General disorders Other	0.00% 0/80 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.	0.00% 0/89 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.	0.00% 0/81 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.
Nervous system disorders Recurrent Stroke (Post-12 months)	0.00% 0/80 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.	0.00% 0/89 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.	1.2% 1/81 • Number of events 1 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.
Cardiac disorders Myocardial Infarction (Post-12 months)	0.00% 0/80 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.	0.00% 0/89 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.	0.00% 0/81 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.
Musculoskeletal and connective tissue disorders Fracture (Post-12 months)	1.2% 1/80 • Number of events 1 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.	0.00% 0/89 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.	1.2% 1/81 • Number of events 1 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.
General disorders Hospitalization (Post-12 months)	7.5% 6/80 • Number of events 6 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.	4.5% 4/89 • Number of events 5 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.	0.00% 0/81 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.
General disorders Death (Post-12 months)	0.00% 0/80 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.	1.1% 1/89 • Number of events 1 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.	0.00% 0/81 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.
General disorders Significant incapacity to perform ADLs for >48 hrs (Post-12 months)	0.00% 0/80 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.	0.00% 0/89 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.	0.00% 0/81 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.
General disorders Other (Post-12 months)	1.2% 1/80 • Number of events 1 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.	0.00% 0/89 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.	0.00% 0/81 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.

Other adverse events

Additional Information

Dr. Darcy Reisman, PT, PhD, FAPTA

University of Delaware

Phone: 302-831-0508

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	FAST+SAM n=80 participants at risk Subjects participate in fast walking training in combination with a step activity monitoring program FAST+SAM: Subjects participate in fast walking training plus a step activity monitoring program 3x/week for 12 weeks	FAST Alone n=89 participants at risk Subjects participate in fast walking training FAST: Subjects participate in fast walking training 3x/week for 12 weeks.	SAM Alone n=81 participants at risk Subjects participate in a step activity monitoring program SAM: Subjects participate in a step activity monitoring program 3x/week for 12 weeks.
General disorders Falls (Randomization-Post)	10.0% 8/80 • Number of events 9 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.	15.7% 14/89 • Number of events 26 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.	7.4% 6/81 • Number of events 9 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.
Respiratory, thoracic and mediastinal disorders Dyspnea (Randomization-Post)	0.00% 0/80 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.	0.00% 0/89 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.	0.00% 0/81 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.
Skin and subcutaneous tissue disorders Open sore/blister/cut (Randomization-Post)	0.00% 0/80 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.	0.00% 0/89 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.	0.00% 0/81 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.
Musculoskeletal and connective tissue disorders Muscle pain/soreness lasting >48 hrs (Randomization-Post)	5.0% 4/80 • Number of events 4 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.	10.1% 9/89 • Number of events 9 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.	2.5% 2/81 • Number of events 2 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.
General disorders Dizziness/fainting (Randomization-Post)	0.00% 0/80 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.	1.1% 1/89 • Number of events 1 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.	0.00% 0/81 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.
General disorders Diaphoresis (Randomization-Post)	0.00% 0/80 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.	0.00% 0/89 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.	0.00% 0/81 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.
General disorders COVID-19 illness (Randomization-Post)	2.5% 2/80 • Number of events 2 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.	1.1% 1/89 • Number of events 1 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.	0.00% 0/81 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.
General disorders Other (Randomization-Post)	1.2% 1/80 • Number of events 1 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.	3.4% 3/89 • Number of events 3 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.	3.7% 3/81 • Number of events 3 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.
General disorders Falls (Post-12 months)	7.5% 6/80 • Number of events 6 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.	4.5% 4/89 • Number of events 6 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.	4.9% 4/81 • Number of events 4 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.
General disorders Dyspnea (Post-12 months)	0.00% 0/80 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.	0.00% 0/89 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.	0.00% 0/81 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.
Skin and subcutaneous tissue disorders Open sore/blister/cut (Post-12 months)	0.00% 0/80 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.	0.00% 0/89 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.	1.2% 1/81 • Number of events 1 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.
Musculoskeletal and connective tissue disorders Muscle pain/soreness lasting >48 hrs (Post-12 months)	1.2% 1/80 • Number of events 1 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.	2.2% 2/89 • Number of events 2 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.	1.2% 1/81 • Number of events 1 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.
General disorders Dizziness/fainting (Post-12 months)	0.00% 0/80 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.	2.2% 2/89 • Number of events 2 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.	0.00% 0/81 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.
General disorders Diaphoresis (Post-12 months)	0.00% 0/80 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.	0.00% 0/89 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.	0.00% 0/81 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.
General disorders COVID-19 illness (Post-12 months)	0.00% 0/80 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.	0.00% 0/89 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.	0.00% 0/81 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.
General disorders Other (Post-12 months)	3.8% 3/80 • Number of events 4 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.	2.2% 2/89 • Number of events 2 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.	2.5% 2/81 • Number of events 2 • Events separated into those occurring from randomization through post-intervention (Post - approximately 3 months) and from post-intervention (Post) up to 12 months. Systematic - regularly assessed at study appointments and scheduled phone follow-ups.