Trial Outcomes & Findings for Movement Intervention for Memory Enhancement (NCT NCT03475316)
NCT ID: NCT03475316
Last Updated: 2021-08-16
Results Overview
Improvement in EF will be measured through a composite score from 3 tests. (1) The Digit Symbol Substitution test is a measure of attention and speed of processing. Scoring is based on the total number of correct responses generated over 90 seconds. Higher values reflect better outcome. (2) Flanker Test is a measure of speed of processing, attention and inhibitory control. Scoring is based on accuracy and reaction time. Lower values reflect better outcome. (3) Walking While Talking (repeating alternating letters of the alphabet) gait speed (centimeters/second) will be measured using a electronic walkway system. Higher values reflect better outcome. The scores on the 3 tests are standardized and summed to obtain a single z-score. The Z-score indicates the number of standard deviations away from the mean of the study population and a value of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean.
COMPLETED
NA
25 participants
Baseline, 6 months
2021-08-16
Participant Flow
Participant milestones
| Measure |
Social Dancing
The program includes Fox-trot, Waltz, and Latin dances.
Social Dancing: 90-min dance sessions twice weekly for 6-months. The session includes warm-up, dance and cool down.
|
Treadmill Walking
The treadmill walking training protocol is based on the recommendations of the American College of Sports Medicine (ACSM) and American Heart Association (AHA) for older adults.
Treadmill Walking: Each session starts with 5-10 minutes of warm-up walking at comfortable speed. Speed is gradually increased to the level at which participants felt it is 'somewhat hard' for two 35 minute sessions with breaks in between followed by 5-10 minute cool down period (total 90 min to match dance group).
|
|---|---|---|
|
6 Month Intervention
STARTED
|
13
|
12
|
|
6 Month Intervention
COMPLETED
|
8
|
8
|
|
6 Month Intervention
NOT COMPLETED
|
5
|
4
|
|
9 Months
STARTED
|
8
|
8
|
|
9 Months
COMPLETED
|
5
|
4
|
|
9 Months
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
| Measure |
Social Dancing
The program includes Fox-trot, Waltz, and Latin dances.
Social Dancing: 90-min dance sessions twice weekly for 6-months. The session includes warm-up, dance and cool down.
|
Treadmill Walking
The treadmill walking training protocol is based on the recommendations of the American College of Sports Medicine (ACSM) and American Heart Association (AHA) for older adults.
Treadmill Walking: Each session starts with 5-10 minutes of warm-up walking at comfortable speed. Speed is gradually increased to the level at which participants felt it is 'somewhat hard' for two 35 minute sessions with breaks in between followed by 5-10 minute cool down period (total 90 min to match dance group).
|
|---|---|---|
|
6 Month Intervention
Adverse Event
|
2
|
1
|
|
6 Month Intervention
Withdrawal by Subject
|
2
|
0
|
|
6 Month Intervention
Study stopped due to COVID pandemic
|
1
|
3
|
|
9 Months
Study stopped due to COVID pandemic
|
3
|
4
|
Baseline Characteristics
Movement Intervention for Memory Enhancement
Baseline characteristics by cohort
| Measure |
Social Dancing
n=13 Participants
The program includes Fox-trot, Waltz, and Latin dances.
Social Dancing: 90-min dance sessions twice weekly for 6-months. The session includes warm-up, dance and cool down.
|
Treadmill Walking
n=12 Participants
The treadmill walking training protocol is based on the recommendations of the American College of Sports Medicine (ACSM) and American Heart Association (AHA) for older adults.
Treadmill Walking: Each session starts with 5-10 minutes of warm-up walking at comfortable speed. Speed is gradually increased to the level at which participants felt it is 'somewhat hard' for two 35 minute sessions with breaks in between followed by 5-10 minute cool down period (total 90 min to match dance group).
|
Total
n=25 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
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Age, Continuous
|
77.4 years
STANDARD_DEVIATION 5.82 • n=5 Participants
|
75.43 years
STANDARD_DEVIATION 5.84 • n=7 Participants
|
76.45 years
STANDARD_DEVIATION 5.79 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
12 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Years of education
|
16.62 years
STANDARD_DEVIATION 4.61 • n=5 Participants
|
14.67 years
STANDARD_DEVIATION 4.23 • n=7 Participants
|
15.68 years
STANDARD_DEVIATION 4.51 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 monthsPopulation: Includes all participants who were randomized except 3 participants in the Treadmill walking group who were missing 1 or more of the 3 composite score tests.
Improvement in EF will be measured through a composite score from 3 tests. (1) The Digit Symbol Substitution test is a measure of attention and speed of processing. Scoring is based on the total number of correct responses generated over 90 seconds. Higher values reflect better outcome. (2) Flanker Test is a measure of speed of processing, attention and inhibitory control. Scoring is based on accuracy and reaction time. Lower values reflect better outcome. (3) Walking While Talking (repeating alternating letters of the alphabet) gait speed (centimeters/second) will be measured using a electronic walkway system. Higher values reflect better outcome. The scores on the 3 tests are standardized and summed to obtain a single z-score. The Z-score indicates the number of standard deviations away from the mean of the study population and a value of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean.
Outcome measures
| Measure |
Social Dancing
n=13 Participants
The program includes Fox-trot, Waltz, and Latin dances.
Social Dancing: 90-min dance sessions twice weekly for 6-months. The session includes warm-up, dance and cool down.
|
Treadmill Walking
n=9 Participants
The treadmill walking training protocol is based on the recommendations of the American College of Sports Medicine (ACSM) and American Heart Association (AHA) for older adults.
Treadmill Walking: Each session starts with 5-10 minutes of warm-up walking at comfortable speed. Speed is gradually increased to the level at which participants felt it is 'somewhat hard' for two 35 minute sessions with breaks in between followed by 5-10 minute cool down period (total 90 min to match dance group).
|
|---|---|---|
|
Executive Function (EF).
|
1.16 z score
Standard Error 0.42
|
0.99 z score
Standard Error 0.39
|
SECONDARY outcome
Timeframe: Baseline, 6 monthsPopulation: Includes all participants who completed the baseline MRI session and was randomized, except 3 participants in the Social Dancing group and 2 participants in the Treadmill Walking group with incomplete tasks/session or corrupted data files.
Functional Magnetic Resonance Imaging will be used to investigate neuroplasticity under three conditions: 'imagined Walking While Talking' task, Digit Symbol Substitution test and Flanker interference tests. Functional activation/deactivation patterns recorded by Functional Magnetic Resonance Imaging in response to the three tests will be examined within each participant before and after the intervention. The values measured as factor scores reflect change in functional activation/deactivation covariance patterns from pre to post intervention as a function intervention (social dancing vs. treadmill walking). Larger absolute values reflect more change in functional activation/deactivation covariance patterns from pre to post intervention on each of the three tasks. There is no set minimum and maximum values of the scale.
Outcome measures
| Measure |
Social Dancing
n=9 Participants
The program includes Fox-trot, Waltz, and Latin dances.
Social Dancing: 90-min dance sessions twice weekly for 6-months. The session includes warm-up, dance and cool down.
|
Treadmill Walking
n=6 Participants
The treadmill walking training protocol is based on the recommendations of the American College of Sports Medicine (ACSM) and American Heart Association (AHA) for older adults.
Treadmill Walking: Each session starts with 5-10 minutes of warm-up walking at comfortable speed. Speed is gradually increased to the level at which participants felt it is 'somewhat hard' for two 35 minute sessions with breaks in between followed by 5-10 minute cool down period (total 90 min to match dance group).
|
|---|---|---|
|
Neuroplasticity.
functional activation/deactivation covariance patterns during Digit Symbol Substitution test
|
-9.68 units on a scale (factor scores)
Standard Error 170.38
|
-273.47 units on a scale (factor scores)
Standard Error 492.47
|
|
Neuroplasticity.
functional activation/deactivation covariance patterns during Flanker Interference test
|
6.82 units on a scale (factor scores)
Standard Error 30.98
|
-17.44 units on a scale (factor scores)
Standard Error 53.73
|
|
Neuroplasticity.
functional activation/deactivation covariance patterns during imagined Walking While Talking
|
81.30 units on a scale (factor scores)
Standard Error 63.16
|
21.94 units on a scale (factor scores)
Standard Error 106.65
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6 monthsLifestyle changes will be measured at baseline and post-intervention through the Community Healthy Activities Model Program for Seniors (CHAMPS) questionnaire. CHAMPS scale measures weekly frequency/week of moderate-intensity exercise-related activities. Scores range from 0 to 133 with higher score indicating more exercise
Outcome measures
| Measure |
Social Dancing
n=13 Participants
The program includes Fox-trot, Waltz, and Latin dances.
Social Dancing: 90-min dance sessions twice weekly for 6-months. The session includes warm-up, dance and cool down.
|
Treadmill Walking
n=12 Participants
The treadmill walking training protocol is based on the recommendations of the American College of Sports Medicine (ACSM) and American Heart Association (AHA) for older adults.
Treadmill Walking: Each session starts with 5-10 minutes of warm-up walking at comfortable speed. Speed is gradually increased to the level at which participants felt it is 'somewhat hard' for two 35 minute sessions with breaks in between followed by 5-10 minute cool down period (total 90 min to match dance group).
|
|---|---|---|
|
Lifestyle Changes.
|
0.41 score on a scale
Standard Error 1.09
|
-0.36 score on a scale
Standard Error 2.47
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6 monthsChanges in gait speed will be measured at baseline and post-intervention through a quantitative gait mat. Gait is measured in centimeters per second and higher values indicate faster walking speed.
Outcome measures
| Measure |
Social Dancing
n=13 Participants
The program includes Fox-trot, Waltz, and Latin dances.
Social Dancing: 90-min dance sessions twice weekly for 6-months. The session includes warm-up, dance and cool down.
|
Treadmill Walking
n=12 Participants
The treadmill walking training protocol is based on the recommendations of the American College of Sports Medicine (ACSM) and American Heart Association (AHA) for older adults.
Treadmill Walking: Each session starts with 5-10 minutes of warm-up walking at comfortable speed. Speed is gradually increased to the level at which participants felt it is 'somewhat hard' for two 35 minute sessions with breaks in between followed by 5-10 minute cool down period (total 90 min to match dance group).
|
|---|---|---|
|
Gait.
|
11.39 centimeters per second
Standard Error 7.26
|
4.11 centimeters per second
Standard Error 4.56
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6 monthsPopulation: Includes all randomized participants, but excludes 8 participants in the experimental group who were unable to do the assessment.
Changes in balance will be measures at baseline and post-intervention using the Unipedal stance (measured in seconds). Higher time indicates better balance.
Outcome measures
| Measure |
Social Dancing
n=8 Participants
The program includes Fox-trot, Waltz, and Latin dances.
Social Dancing: 90-min dance sessions twice weekly for 6-months. The session includes warm-up, dance and cool down.
|
Treadmill Walking
n=12 Participants
The treadmill walking training protocol is based on the recommendations of the American College of Sports Medicine (ACSM) and American Heart Association (AHA) for older adults.
Treadmill Walking: Each session starts with 5-10 minutes of warm-up walking at comfortable speed. Speed is gradually increased to the level at which participants felt it is 'somewhat hard' for two 35 minute sessions with breaks in between followed by 5-10 minute cool down period (total 90 min to match dance group).
|
|---|---|---|
|
Balance
|
2.03 seconds
Standard Error 4.72
|
1.46 seconds
Standard Error 3.55
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6 monthsPopulation: This measure was not completed; therefore, no outcome data is included.
Changes in function assessed by 4 key activities of daily living tasks-bathing, dressing, walking, and transferring. Scores range from 0 to 8 with higher scores indicating worse outcome.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 6 monthsChanges in depressive symptoms assessed using the 30 item GDS, scores range from 0 (not depressed) to 30 (depressed).
Outcome measures
| Measure |
Social Dancing
n=13 Participants
The program includes Fox-trot, Waltz, and Latin dances.
Social Dancing: 90-min dance sessions twice weekly for 6-months. The session includes warm-up, dance and cool down.
|
Treadmill Walking
n=12 Participants
The treadmill walking training protocol is based on the recommendations of the American College of Sports Medicine (ACSM) and American Heart Association (AHA) for older adults.
Treadmill Walking: Each session starts with 5-10 minutes of warm-up walking at comfortable speed. Speed is gradually increased to the level at which participants felt it is 'somewhat hard' for two 35 minute sessions with breaks in between followed by 5-10 minute cool down period (total 90 min to match dance group).
|
|---|---|---|
|
The Geriatric Depression Scale (GDS).
|
1.41 score on a scale
Standard Error 0.55
|
0.33 score on a scale
Standard Error 0.96
|
Adverse Events
Social Dancing
Treadmill Walking
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Social Dancing
n=13 participants at risk
The program includes Fox-trot, Waltz, and Latin dances.
Social Dancing: 90-min dance sessions twice weekly for 6-months. The session includes warm-up, dance and cool down.
|
Treadmill Walking
n=12 participants at risk
The treadmill walking training protocol is based on the recommendations of the American College of Sports Medicine (ACSM) and American Heart Association (AHA) for older adults.
Treadmill Walking: Each session starts with 5-10 minutes of warm-up walking at comfortable speed. Speed is gradually increased to the level at which participants felt it is 'somewhat hard' for two 35 minute sessions with breaks in between followed by 5-10 minute cool down period (total 90 min to match dance group).
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Falls
|
30.8%
4/13 • Number of events 4 • 9 months
|
8.3%
1/12 • Number of events 1 • 9 months
|
|
Musculoskeletal and connective tissue disorders
Leg pain
|
0.00%
0/13 • 9 months
|
16.7%
2/12 • Number of events 2 • 9 months
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
0.00%
0/13 • 9 months
|
8.3%
1/12 • Number of events 2 • 9 months
|
|
Vascular disorders
High blood pressure
|
7.7%
1/13 • Number of events 1 • 9 months
|
16.7%
2/12 • Number of events 2 • 9 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place