Trial Outcomes & Findings for mSIM: Mobile Simultaneous Aerobic Exercise and Memory Training Intervention for Amnestic Mild Cognitive Impairment (NCT NCT04185298)

Last Updated: 2025-01-14

Results Overview

Global Z-Score including results from RAVLT (Rey's Auditory Verbal Learning Test), Wechsler Memory Scale Fourth Edition (WMS-IV) Logical Memory and Visual Reproduction tests. The global z score was constructed by: First z-transforming all raw test scores (RAVLT, Logical Memory (LM) I Total, LM II Total, Visual Reproduction (VR) I and VR II) Averaging over RAVLT Z, LM Z, and VR Z to obtain a global Z 0=sample mean; higher scores indicate better outcomes.

Recruitment status

TERMINATED

Study phase

Target enrollment

12 participants

Primary outcome timeframe

Baseline, approximately 3 months and approximately 6 months

Results posted on

2025-01-14

Participant Flow

Of the 22 participants that were consented, 1 failed screening due to MoCa score and 2 were lost to follow up. Participants were then screened prior to randomization, which included exercise clearance and full neurocognitive assessment. Of the 19 that were screened, 12 were randomized because 6 failed to meet criteria due to neurocognitive assessment, and 1 was unable to obtain clearance to participate in an exercise intervention.

Participant milestones

Participant milestones
Measure	Group 1 (No Treatment) Group 1: Participants will have continuous activity monitoring (via Fitbit)	Group 2 (Experimental) Group 2: Participants will receive the mSIM treatment and have their activity monitored continuously (via Fitbit)
Overall Study STARTED	4	8
Overall Study COMPLETED	3	2
Overall Study NOT COMPLETED	1	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1 (No Treatment) Group 1: Participants will have continuous activity monitoring (via Fitbit)	Group 2 (Experimental) Group 2: Participants will receive the mSIM treatment and have their activity monitored continuously (via Fitbit)
Overall Study Lost to Follow-up	1	3
Overall Study Withdrawal by Subject	0	3

Baseline Characteristics

mSIM: Mobile Simultaneous Aerobic Exercise and Memory Training Intervention for Amnestic Mild Cognitive Impairment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 (No Treatment) n=4 Participants Group 1: Participants will have continuous activity monitoring (via Fitbit)	Group 2 (Experimental) n=8 Participants Group 2: Participants will receive the mSIM treatment and have their activity monitored continuously (via Fitbit)	Total n=12 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Age, Continuous	76.3 years STANDARD_DEVIATION 6.4 • n=5 Participants	69.7 years STANDARD_DEVIATION 4.5 • n=7 Participants	71.7 years STANDARD_DEVIATION 5.7 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants	8 Participants n=7 Participants	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, approximately 3 months and approximately 6 months

Population: Of the 8 participants that were randomized into the intervention, only 7 participated in baseline assessments. Of the 7 with baseline data, only 2 completed follow up assessments.

Outcome measures

Outcome measures
Measure	Group 1 (No Treatment) n=3 Participants Group 1: Participants will have continuous activity monitoring (via Fitbit)	Group 2 (Experimental) n=7 Participants Group 2: Participants will receive the mSIM treatment and have their activity monitored continuously (via Fitbit)
Memory Function Composite Score 3 Months	0.87 Z-score Standard Deviation 0.49	-1.30 Z-score Standard Deviation 4.19
Memory Function Composite Score 6 Months	0.66 Z-score Standard Deviation 1.63	-0.98 Z-score Standard Deviation 4.33
Memory Function Composite Score Baseline	0.5 Z-score Standard Deviation 0.84	-0.21 Z-score Standard Deviation 1.80

PRIMARY outcome

Timeframe: Baseline, approximately 3 months and approximately 6 months

Population: Of the 8 participants that were randomized into the intervention, only 7 participated in baseline assessments. Of the 7 with baseline data, only 2 completed follow up assessments.

Assessed using the Multifactorial Memory Questionnaire (MMQ) Satisfaction Sub-scale (0-72 points). Higher scores indicate better outcomes.

Outcome measures

Outcome measures
Measure	Group 1 (No Treatment) n=3 Participants Group 1: Participants will have continuous activity monitoring (via Fitbit)	Group 2 (Experimental) n=7 Participants Group 2: Participants will receive the mSIM treatment and have their activity monitored continuously (via Fitbit)
Functional Abilities Baseline	24.67 scores on a scale Standard Deviation 13.01	26.86 scores on a scale Standard Deviation 15.65
Functional Abilities 6 Months	32.67 scores on a scale Standard Deviation 16.77	21.00 scores on a scale Standard Deviation 5.66
Functional Abilities 3 Months	26.33 scores on a scale Standard Deviation 14.19	19.00 scores on a scale Standard Deviation 11.31

SECONDARY outcome

Timeframe: Baseline and approximately 6 months

Resting level of serum-derived BDNF

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and approximately 6 months

Resting level of plasma-derived norepinephrine (NE)

Outcome measures

Outcome data not reported

Adverse Events

Group 1 (No Treatment)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Group 2 (Experimental)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Group 1 (No Treatment) n=4 participants at risk Group 1: Participants will have continuous activity monitoring (via Fitbit)	Group 2 (Experimental) n=8 participants at risk Group 2: Participants will receive the mSIM treatment and have their activity monitored continuously (via Fitbit)
Injury, poisoning and procedural complications Neck injury	0.00% 0/4 • 14 weeks	12.5% 1/8 • Number of events 1 • 14 weeks
Injury, poisoning and procedural complications Rib pain	0.00% 0/4 • 14 weeks	12.5% 1/8 • Number of events 1 • 14 weeks
Injury, poisoning and procedural complications Head injury	0.00% 0/4 • 14 weeks	12.5% 1/8 • Number of events 1 • 14 weeks
Musculoskeletal and connective tissue disorders Knee pain	0.00% 0/4 • 14 weeks	12.5% 1/8 • Number of events 1 • 14 weeks
General disorders Back pain	25.0% 1/4 • Number of events 1 • 14 weeks	0.00% 0/8 • 14 weeks
Infections and infestations Tooth pain	25.0% 1/4 • Number of events 1 • 14 weeks	0.00% 0/8 • 14 weeks
Nervous system disorders Headache	25.0% 1/4 • Number of events 1 • 14 weeks	0.00% 0/8 • 14 weeks
Injury, poisoning and procedural complications Limb pain	0.00% 0/4 • 14 weeks	12.5% 1/8 • Number of events 1 • 14 weeks
Gastrointestinal disorders Nausea	25.0% 1/4 • Number of events 1 • 14 weeks	0.00% 0/8 • 14 weeks
Infections and infestations Shingles	25.0% 1/4 • Number of events 1 • 14 weeks	0.00% 0/8 • 14 weeks

Additional Information

Dr. Jennifer Bramen

Saint John's Cancer Institute

Phone: 310-525-0865

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place