Trial Outcomes & Findings for Exercise for Brain Health in the Fight Against Alzheimer's Disease (NCT NCT03727360)
NCT ID: NCT03727360
Last Updated: 2026-05-01
Results Overview
Rey Auditory Verbal Learning Test Sum of Trials 1-5. Fifteen words are presented verbally, and participant is asked to recall as many as possible after each trial. The total sum of the words correctly recalled across trials 1 to 5 is recorded.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
124 participants
Primary outcome timeframe
Baseline and 6 months
Results posted on
2026-05-01
Participant Flow
Advertising and recruitment resulted in 5,284 online pre-screening surveys, which led to 266 individuals who volunteered and completed the in-person informed consent visit. Among the 266 consented individuals, 117 (44%) were determined to not meet the inclusion/exclusion criteria, with the most common reason being identification of cognitive impairment, and 25 voluntarily withdrew from the study, leaving 124 who completed baseline testing. 106 of 124 completed the entire protocol.
After informed consent, all physician consent and MRI screening forms were completed (approximately 2-6 weeks) before baseline testing was scheduled. Participants were then assigned to a treatment arm and completed the baseline testing. A total of 124 participants completed baseline, and 5 withdrew before starting the intervention. 119 started one of the two arms, and 106 of the 124 consented individuals completed the entire 6-month exercise intervention with baseline and follow-up testing.
Participant milestones
| Measure |
Flexibility Control
Group exercise delivered synchronously on Zoom including: warmup, static stretching of all major muscle groups (neck, shoulders, arms, trunk, hips, legs and ankles), balance and toning exercise, marching in place, seated or floor exercise at 30-40% of maximal heart rate, cool down. One hour per session, four sessions per week, 26 weeks.
|
Exercise Training
Group exercise delivered synchronously on Zoom including: warmup, static stretching of all major muscle groups (neck, shoulders, arms, trunk, hips, legs and ankles), balance and toning exercise, marching in place, dynamic cardiovascular exercise at 60-70% of maximal heart rate, cool down. One hour per session, four sessions per week, 26 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
55
|
64
|
|
Overall Study
COMPLETED
|
51
|
55
|
|
Overall Study
NOT COMPLETED
|
4
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
These are the number of participants who completed the intervention arms and completed both the baseline and 6-month testing.
Baseline characteristics by cohort
| Measure |
Exercise Training
n=55 Participants
Group exercise delivered synchronously on Zoom including: warmup, static stretching of all major muscle groups (neck, shoulders, arms, trunk, hips, legs and ankles), balance and toning exercise, marching in place, dynamic cardiovascular exercise at 60-70% of maximal heart rate, cool down. One hour per session, four sessions per week, 26 weeks.
|
Flexibility Control
n=51 Participants
Group exercise delivered synchronously on Zoom including: warmup, static stretching of all major muscle groups (neck, shoulders, arms, trunk, hips, legs and ankles), balance and toning exercise, marching in place, seated or floor exercise at 30-40% of maximal heart rate, cool down. One hour per session, four sessions per week, 26 weeks.
|
Total
n=106 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.4 Years
STANDARD_DEVIATION 6.2 • n=14 Participants
|
67.8 Years
STANDARD_DEVIATION 5.6 • n=34 Participants
|
68.1 Years
STANDARD_DEVIATION 5.9 • n=69 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=14 Participants
|
39 Participants
n=34 Participants
|
84 Participants
n=69 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=14 Participants
|
12 Participants
n=34 Participants
|
22 Participants
n=69 Participants
|
|
Race/Ethnicity, Customized
Self-Reported Race · Prefer not to say
|
2 Participants
n=14 Participants • These are the number of participants who completed the intervention arms and completed both the baseline and 6-month testing.
|
1 Participants
n=34 Participants • These are the number of participants who completed the intervention arms and completed both the baseline and 6-month testing.
|
3 Participants
n=69 Participants • These are the number of participants who completed the intervention arms and completed both the baseline and 6-month testing.
|
|
Race/Ethnicity, Customized
Self-Reported Race · White
|
43 Participants
n=14 Participants • These are the number of participants who completed the intervention arms and completed both the baseline and 6-month testing.
|
37 Participants
n=34 Participants • These are the number of participants who completed the intervention arms and completed both the baseline and 6-month testing.
|
80 Participants
n=69 Participants • These are the number of participants who completed the intervention arms and completed both the baseline and 6-month testing.
|
|
Race/Ethnicity, Customized
Self-Reported Race · Black
|
7 Participants
n=14 Participants • These are the number of participants who completed the intervention arms and completed both the baseline and 6-month testing.
|
11 Participants
n=34 Participants • These are the number of participants who completed the intervention arms and completed both the baseline and 6-month testing.
|
18 Participants
n=69 Participants • These are the number of participants who completed the intervention arms and completed both the baseline and 6-month testing.
|
|
Race/Ethnicity, Customized
Self-Reported Race · Asian
|
3 Participants
n=14 Participants • These are the number of participants who completed the intervention arms and completed both the baseline and 6-month testing.
|
2 Participants
n=34 Participants • These are the number of participants who completed the intervention arms and completed both the baseline and 6-month testing.
|
5 Participants
n=69 Participants • These are the number of participants who completed the intervention arms and completed both the baseline and 6-month testing.
|
|
Education
High School
|
4 Participants
n=14 Participants • These are the number of participants who completed the intervention arms and completed both the baseline and 6-month testing.
|
0 Participants
n=34 Participants • These are the number of participants who completed the intervention arms and completed both the baseline and 6-month testing.
|
4 Participants
n=69 Participants • These are the number of participants who completed the intervention arms and completed both the baseline and 6-month testing.
|
|
Education
Some College
|
2 Participants
n=14 Participants • These are the number of participants who completed the intervention arms and completed both the baseline and 6-month testing.
|
0 Participants
n=34 Participants • These are the number of participants who completed the intervention arms and completed both the baseline and 6-month testing.
|
2 Participants
n=69 Participants • These are the number of participants who completed the intervention arms and completed both the baseline and 6-month testing.
|
|
Education
Bachelors Degree
|
12 Participants
n=14 Participants • These are the number of participants who completed the intervention arms and completed both the baseline and 6-month testing.
|
21 Participants
n=34 Participants • These are the number of participants who completed the intervention arms and completed both the baseline and 6-month testing.
|
33 Participants
n=69 Participants • These are the number of participants who completed the intervention arms and completed both the baseline and 6-month testing.
|
|
Education
Graduate Degree
|
27 Participants
n=14 Participants • These are the number of participants who completed the intervention arms and completed both the baseline and 6-month testing.
|
22 Participants
n=34 Participants • These are the number of participants who completed the intervention arms and completed both the baseline and 6-month testing.
|
49 Participants
n=69 Participants • These are the number of participants who completed the intervention arms and completed both the baseline and 6-month testing.
|
|
Education
Doctoral Degree
|
10 Participants
n=14 Participants • These are the number of participants who completed the intervention arms and completed both the baseline and 6-month testing.
|
8 Participants
n=34 Participants • These are the number of participants who completed the intervention arms and completed both the baseline and 6-month testing.
|
18 Participants
n=69 Participants • These are the number of participants who completed the intervention arms and completed both the baseline and 6-month testing.
|
PRIMARY outcome
Timeframe: Baseline and 6 monthsPopulation: These are the number of participants who completed the intervention arms and completed both the baseline and 6-month testing.
Rey Auditory Verbal Learning Test Sum of Trials 1-5. Fifteen words are presented verbally, and participant is asked to recall as many as possible after each trial. The total sum of the words correctly recalled across trials 1 to 5 is recorded.
Outcome measures
| Measure |
Exercise Training
n=55 Participants
Group exercise and treadmill walking
|
Flexibility Control
n=51 Participants
Group exercise and flexibility exercise
|
|---|---|---|
|
Rey Auditory Verbal Learning Test Sum of Trials 1-5
Baseline
|
49.7 Sum of words recalled Trials 1 to 5
Standard Deviation 8.2
|
47.6 Sum of words recalled Trials 1 to 5
Standard Deviation 10.4
|
|
Rey Auditory Verbal Learning Test Sum of Trials 1-5
6-Months
|
51.6 Sum of words recalled Trials 1 to 5
Standard Deviation 9.2
|
49.4 Sum of words recalled Trials 1 to 5
Standard Deviation 9.1
|
PRIMARY outcome
Timeframe: Baseline and 6 monthsPopulation: These are the number of participants who completed the intervention arms and completed both the baseline and 6-month testing.
Famous minus Not Famous Name Discrimination activation using event-related fMRI (correct trials only), derived from standard preprocessing and control of family-wise error rate. The primary outcome reflects the mean activation intensity from all brain regions that were shown to be activated by the task in both the Exercise Training and Flexibility Control conditions.
Outcome measures
| Measure |
Exercise Training
n=55 Participants
Group exercise and treadmill walking
|
Flexibility Control
n=51 Participants
Group exercise and flexibility exercise
|
|---|---|---|
|
Famous Name Discrimination fMRI Activation
Baseline
|
5.20 BOLD intensity (standardized beta)
Standard Error 0.90
|
5.13 BOLD intensity (standardized beta)
Standard Error 1.01
|
|
Famous Name Discrimination fMRI Activation
6-Months
|
4.25 BOLD intensity (standardized beta)
Standard Error 0.80
|
3.19 BOLD intensity (standardized beta)
Standard Error 0.91
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: These are the number of participants who completed the intervention arms and completed both the baseline and 6-month testing.
Estimated peak rate of oxygen consumption during a treadmill graded exercise test, a measure of cardiorespiratory fitness.
Outcome measures
| Measure |
Exercise Training
n=55 Participants
Group exercise and treadmill walking
|
Flexibility Control
n=51 Participants
Group exercise and flexibility exercise
|
|---|---|---|
|
Peak Rate of Oxygen Consumption (VO2peak)
Baseline
|
1.34 Liters per minute
Standard Error 0.05
|
1.33 Liters per minute
Standard Error 0.05
|
|
Peak Rate of Oxygen Consumption (VO2peak)
6-Months
|
1.31 Liters per minute
Standard Error 0.05
|
1.35 Liters per minute
Standard Error 0.05
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: These are the number of participants who completed the intervention arms and completed both the baseline and 6-month testing.
Distance walked in 6 minutes
Outcome measures
| Measure |
Exercise Training
n=55 Participants
Group exercise and treadmill walking
|
Flexibility Control
n=51 Participants
Group exercise and flexibility exercise
|
|---|---|---|
|
6 Minute Walk Test
Baseline
|
1758.3 Feet, Distance walked in 6 minutes
Standard Error 37.4
|
1712.8 Feet, Distance walked in 6 minutes
Standard Error 38.9
|
|
6 Minute Walk Test
6-Months
|
1796.7 Feet, Distance walked in 6 minutes
Standard Error 38.0
|
1734.3 Feet, Distance walked in 6 minutes
Standard Error 40.9
|
Adverse Events
Exercise Training
Serious events: 3 serious events
Other events: 10 other events
Deaths: 0 deaths
Flexibility Control
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Exercise Training
n=64 participants at risk
Group exercise delivered synchronously on Zoom including: warmup, static stretching of all major muscle groups (neck, shoulders, arms, trunk, hips, legs and ankles), balance and toning exercise, marching in place, dynamic cardiovascular exercise at 60-70% of maximal heart rate, cool down. One hour per session, four sessions per week, 26 weeks.
|
Flexibility Control
n=55 participants at risk
Group exercise delivered synchronously on Zoom including: warmup, static stretching of all major muscle groups (neck, shoulders, arms, trunk, hips, legs and ankles), balance and toning exercise, marching in place, seated or floor exercise at 30-40% of maximal heart rate, cool down. One hour per session, four sessions per week, 26 weeks.
|
|---|---|---|
|
General disorders
Fall
|
1.6%
1/64 • From enrollment until withdrawal from study or end of 6-month follow up, a maximum of 6 months.
We used standard forms and definitions.
|
0.00%
0/55 • From enrollment until withdrawal from study or end of 6-month follow up, a maximum of 6 months.
We used standard forms and definitions.
|
|
General disorders
fainted
|
1.6%
1/64 • From enrollment until withdrawal from study or end of 6-month follow up, a maximum of 6 months.
We used standard forms and definitions.
|
0.00%
0/55 • From enrollment until withdrawal from study or end of 6-month follow up, a maximum of 6 months.
We used standard forms and definitions.
|
|
General disorders
Surgical Procedure
|
1.6%
1/64 • From enrollment until withdrawal from study or end of 6-month follow up, a maximum of 6 months.
We used standard forms and definitions.
|
1.8%
1/55 • From enrollment until withdrawal from study or end of 6-month follow up, a maximum of 6 months.
We used standard forms and definitions.
|
Other adverse events
| Measure |
Exercise Training
n=64 participants at risk
Group exercise delivered synchronously on Zoom including: warmup, static stretching of all major muscle groups (neck, shoulders, arms, trunk, hips, legs and ankles), balance and toning exercise, marching in place, dynamic cardiovascular exercise at 60-70% of maximal heart rate, cool down. One hour per session, four sessions per week, 26 weeks.
|
Flexibility Control
n=55 participants at risk
Group exercise delivered synchronously on Zoom including: warmup, static stretching of all major muscle groups (neck, shoulders, arms, trunk, hips, legs and ankles), balance and toning exercise, marching in place, seated or floor exercise at 30-40% of maximal heart rate, cool down. One hour per session, four sessions per week, 26 weeks.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Unrelated joint/muscle injury/pain
|
7.8%
5/64 • From enrollment until withdrawal from study or end of 6-month follow up, a maximum of 6 months.
We used standard forms and definitions.
|
7.3%
4/55 • From enrollment until withdrawal from study or end of 6-month follow up, a maximum of 6 months.
We used standard forms and definitions.
|
|
General disorders
Fall off of yoga ball
|
1.6%
1/64 • From enrollment until withdrawal from study or end of 6-month follow up, a maximum of 6 months.
We used standard forms and definitions.
|
0.00%
0/55 • From enrollment until withdrawal from study or end of 6-month follow up, a maximum of 6 months.
We used standard forms and definitions.
|
|
Musculoskeletal and connective tissue disorders
Mild joint/muscle pain during exercise
|
3.1%
2/64 • From enrollment until withdrawal from study or end of 6-month follow up, a maximum of 6 months.
We used standard forms and definitions.
|
1.8%
1/55 • From enrollment until withdrawal from study or end of 6-month follow up, a maximum of 6 months.
We used standard forms and definitions.
|
|
General disorders
Discomfort after MRI scan
|
0.00%
0/64 • From enrollment until withdrawal from study or end of 6-month follow up, a maximum of 6 months.
We used standard forms and definitions.
|
1.8%
1/55 • From enrollment until withdrawal from study or end of 6-month follow up, a maximum of 6 months.
We used standard forms and definitions.
|
|
General disorders
Minor medical procedure that led to short-term disruption of participation
|
0.00%
0/64 • From enrollment until withdrawal from study or end of 6-month follow up, a maximum of 6 months.
We used standard forms and definitions.
|
3.6%
2/55 • From enrollment until withdrawal from study or end of 6-month follow up, a maximum of 6 months.
We used standard forms and definitions.
|
|
General disorders
Fall at home, no injury
|
1.6%
1/64 • From enrollment until withdrawal from study or end of 6-month follow up, a maximum of 6 months.
We used standard forms and definitions.
|
0.00%
0/55 • From enrollment until withdrawal from study or end of 6-month follow up, a maximum of 6 months.
We used standard forms and definitions.
|
|
General disorders
Mild dizziness after fasting blood draw
|
1.6%
1/64 • From enrollment until withdrawal from study or end of 6-month follow up, a maximum of 6 months.
We used standard forms and definitions.
|
0.00%
0/55 • From enrollment until withdrawal from study or end of 6-month follow up, a maximum of 6 months.
We used standard forms and definitions.
|
Additional Information
J. Carson Smith, PhD
University of Maryland at College Park
Phone: +1 (301) 405-0344
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place