Trial Outcomes & Findings for Pilot Study of Aerobic Exercise in Early Alzheimer's Disease(AD) (NCT NCT01128361)
NCT ID: NCT01128361
Last Updated: 2017-03-13
Results Overview
A composite measure of several memory tests (Logical Memory (Immediate and Delayed), Free and Cued Selective Reminding Test (sum of free recall). Each score was normalized to an independent dataset of individuals without dementia. Then the 4 standardized scores were averaged. Numbers closer to positive indicate better memory performance. The scores are centered around a mean of 0 and standardized so each value represents a fraction of the standard deviation. There are no limits to the scores.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
76 participants
Primary outcome timeframe
week 0, 13, and 26
Results posted on
2017-03-13
Participant Flow
Participant milestones
| Measure |
Aerobic Exercise
Aerobic Exercise: Participants randomized to this group will perform 150 minutes a week of aerobic exercise over 3-5days. Participants will begin exercising 3 times the first week for 20 minutes, increasing to three bouts of 25 minutes the second week. Thereafter, weekly exercise duration will be increased until their target duration of 150 minutes is achieved in week 6. Exercise trainers will assist participants in adjusting exercise routines to achieve their weekly exercise duration goals. Use of equipment, achievement of target HR and safety will be closely monitored by the trainer through the course of the study. Each subject will wear a Polar F4 heart monitor (Polar USA) for recording heart rate during each exercise session. Subjects unable to exercise continuously on the treadmill will perform intermittent training until the target duration is reached. The majority of the exercise sessions will involve walking on a treadmill.
|
Stretching
Stretching: This groups intervention is designed to match the aerobic exercise intervention with respect to participation and socialization. Stretching and toning has been repeatedly used as control intervention for exercise studies.The schedule and format will be identical to the aerobic conditioning group to best balance confounding variables such as attention, social interactions, and other unknown variables that might influence the results. An experienced and trained exercise instructor will run the stretching sessions three days a week at the local YMCA. We will monitor changes in heart rate with Polar F4 heart monitors (Polar USA) during the sessions to assess, and minimize, potential aerobic benefits from the intervention.
|
|---|---|---|
|
Overall Study
STARTED
|
39
|
37
|
|
Overall Study
COMPLETED
|
34
|
34
|
|
Overall Study
NOT COMPLETED
|
5
|
3
|
Reasons for withdrawal
| Measure |
Aerobic Exercise
Aerobic Exercise: Participants randomized to this group will perform 150 minutes a week of aerobic exercise over 3-5days. Participants will begin exercising 3 times the first week for 20 minutes, increasing to three bouts of 25 minutes the second week. Thereafter, weekly exercise duration will be increased until their target duration of 150 minutes is achieved in week 6. Exercise trainers will assist participants in adjusting exercise routines to achieve their weekly exercise duration goals. Use of equipment, achievement of target HR and safety will be closely monitored by the trainer through the course of the study. Each subject will wear a Polar F4 heart monitor (Polar USA) for recording heart rate during each exercise session. Subjects unable to exercise continuously on the treadmill will perform intermittent training until the target duration is reached. The majority of the exercise sessions will involve walking on a treadmill.
|
Stretching
Stretching: This groups intervention is designed to match the aerobic exercise intervention with respect to participation and socialization. Stretching and toning has been repeatedly used as control intervention for exercise studies.The schedule and format will be identical to the aerobic conditioning group to best balance confounding variables such as attention, social interactions, and other unknown variables that might influence the results. An experienced and trained exercise instructor will run the stretching sessions three days a week at the local YMCA. We will monitor changes in heart rate with Polar F4 heart monitors (Polar USA) during the sessions to assess, and minimize, potential aerobic benefits from the intervention.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
5
|
2
|
Baseline Characteristics
Pilot Study of Aerobic Exercise in Early Alzheimer's Disease(AD)
Baseline characteristics by cohort
| Measure |
Aerobic Exercise
n=39 Participants
Aerobic Exercise: Participants randomized to this group will perform 150 minutes a week of aerobic exercise over 3-5days. Participants will begin exercising 3 times the first week for 20 minutes, increasing to three bouts of 25 minutes the second week. Thereafter, weekly exercise duration will be increased until their target duration of 150 minutes is achieved in week 6. Exercise trainers will assist participants in adjusting exercise routines to achieve their weekly exercise duration goals. Use of equipment, achievement of target HR and safety will be closely monitored by the trainer through the course of the study. Each subject will wear a Polar F4 heart monitor (Polar USA) for recording heart rate during each exercise session. Subjects unable to exercise continuously on the treadmill will perform intermittent training until the target duration is reached. The majority of the exercise sessions will involve walking on a treadmill.
|
Stretching
n=37 Participants
Stretching: This groups intervention is designed to match the aerobic exercise intervention with respect to participation and socialization. Stretching and toning has been repeatedly used as control intervention for exercise studies.The schedule and format will be identical to the aerobic conditioning group to best balance confounding variables such as attention, social interactions, and other unknown variables that might influence the results. An experienced and trained exercise instructor will run the stretching sessions three days a week at the local YMCA. We will monitor changes in heart rate with Polar F4 heart monitors (Polar USA) during the sessions to assess, and minimize, potential aerobic benefits from the intervention.
|
Total
n=76 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
39 Participants
n=93 Participants
|
37 Participants
n=4 Participants
|
76 Participants
n=27 Participants
|
|
Age, Continuous
|
74.4 years
STANDARD_DEVIATION 6.7 • n=93 Participants
|
71.4 years
STANDARD_DEVIATION 8.4 • n=4 Participants
|
72.9 years
STANDARD_DEVIATION 7.7 • n=27 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
39 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
37 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
39 participants
n=93 Participants
|
37 participants
n=4 Participants
|
76 participants
n=27 Participants
|
|
Clinical Dementia Rating Sum of Boxes
|
3.54 units on a scale
STANDARD_DEVIATION 1.99 • n=93 Participants
|
3.55 units on a scale
STANDARD_DEVIATION 1.60 • n=4 Participants
|
3.54 units on a scale
STANDARD_DEVIATION 1.81 • n=27 Participants
|
PRIMARY outcome
Timeframe: week 0, 13, and 26Population: Linear mixed models with all available data were used. Thus the overall number of participants analyzed does not necessarily match the means reported at each timepoint.
A composite measure of several memory tests (Logical Memory (Immediate and Delayed), Free and Cued Selective Reminding Test (sum of free recall). Each score was normalized to an independent dataset of individuals without dementia. Then the 4 standardized scores were averaged. Numbers closer to positive indicate better memory performance. The scores are centered around a mean of 0 and standardized so each value represents a fraction of the standard deviation. There are no limits to the scores.
Outcome measures
| Measure |
Aerobic Exercise
n=39 Participants
Aerobic Exercise: Participants randomized to this group will perform 150 minutes a week of aerobic exercise over 3-5days. Participants will begin exercising 3 times the first week for 20 minutes, increasing to three bouts of 25 minutes the second week. Thereafter, weekly exercise duration will be increased until their target duration of 150 minutes is achieved in week 6. Exercise trainers will assist participants in adjusting exercise routines to achieve their weekly exercise duration goals. Use of equipment, achievement of target HR and safety will be closely monitored by the trainer through the course of the study. Each subject will wear a Polar F4 heart monitor (Polar USA) for recording heart rate during each exercise session. Subjects unable to exercise continuously on the treadmill will perform intermittent training until the target duration is reached. The majority of the exercise sessions will involve walking on a treadmill.
|
Stretching
n=37 Participants
Stretching: This groups intervention is designed to match the aerobic exercise intervention with respect to participation and socialization. Stretching and toning has been repeatedly used as control intervention for exercise studies.The schedule and format will be identical to the aerobic conditioning group to best balance confounding variables such as attention, social interactions, and other unknown variables that might influence the results. An experienced and trained exercise instructor will run the stretching sessions three days a week at the local YMCA. We will monitor changes in heart rate with Polar F4 heart monitors (Polar USA) during the sessions to assess, and minimize, potential aerobic benefits from the intervention.
|
|---|---|---|
|
Memory Composite
Baseline
|
-2.5 units on a standardized scale
Standard Deviation 1.4
|
-2.8 units on a standardized scale
Standard Deviation 1.4
|
|
Memory Composite
Week 13
|
-2.3 units on a standardized scale
Standard Deviation 1.5
|
-2.8 units on a standardized scale
Standard Deviation 1.5
|
|
Memory Composite
Week 26
|
-2.3 units on a standardized scale
Standard Deviation 1.7
|
-2.7 units on a standardized scale
Standard Deviation 1.7
|
PRIMARY outcome
Timeframe: Week 0, 13, and 26Population: Linear mixed models were used with all available data included. Overall numbers analyzed do not necessarily match the outcome measure at each timepoint
A composite measure of several memory tests (Logical Memory (Immediate and Delayed), Free and Cued Selective Reminding Test (sum of free recall). Each score was normalized to an independent dataset. Then the 4 standardized scores were averaged. Numbers closer to positive indicate better executive function performance. . The scores are centered around a mean of 0 and standardized so each value represents a fraction of the standard deviation. There are no limits to the scores.
Outcome measures
| Measure |
Aerobic Exercise
n=39 Participants
Aerobic Exercise: Participants randomized to this group will perform 150 minutes a week of aerobic exercise over 3-5days. Participants will begin exercising 3 times the first week for 20 minutes, increasing to three bouts of 25 minutes the second week. Thereafter, weekly exercise duration will be increased until their target duration of 150 minutes is achieved in week 6. Exercise trainers will assist participants in adjusting exercise routines to achieve their weekly exercise duration goals. Use of equipment, achievement of target HR and safety will be closely monitored by the trainer through the course of the study. Each subject will wear a Polar F4 heart monitor (Polar USA) for recording heart rate during each exercise session. Subjects unable to exercise continuously on the treadmill will perform intermittent training until the target duration is reached. The majority of the exercise sessions will involve walking on a treadmill.
|
Stretching
n=37 Participants
Stretching: This groups intervention is designed to match the aerobic exercise intervention with respect to participation and socialization. Stretching and toning has been repeatedly used as control intervention for exercise studies.The schedule and format will be identical to the aerobic conditioning group to best balance confounding variables such as attention, social interactions, and other unknown variables that might influence the results. An experienced and trained exercise instructor will run the stretching sessions three days a week at the local YMCA. We will monitor changes in heart rate with Polar F4 heart monitors (Polar USA) during the sessions to assess, and minimize, potential aerobic benefits from the intervention.
|
|---|---|---|
|
Executive Function Composite
Baseline
|
-1.12 standardized units on a scale
Standard Deviation .82
|
-1.34 standardized units on a scale
Standard Deviation .85
|
|
Executive Function Composite
Week 13
|
-1.09 standardized units on a scale
Standard Deviation .86
|
-1.25 standardized units on a scale
Standard Deviation .94
|
|
Executive Function Composite
Week 26
|
-1.2 standardized units on a scale
Standard Deviation .9
|
-1.33 standardized units on a scale
Standard Deviation .97
|
PRIMARY outcome
Timeframe: Week 0, 13, and 26Population: Linear mixed models were used with all available data. Overall number of participants may not match numbers at each timepoint.
This is a validated measure of disability for individuals with dementia. Higher scores indicate less disability with a score of 100 indicating no disability and 0 indicating no functional ability.
Outcome measures
| Measure |
Aerobic Exercise
n=39 Participants
Aerobic Exercise: Participants randomized to this group will perform 150 minutes a week of aerobic exercise over 3-5days. Participants will begin exercising 3 times the first week for 20 minutes, increasing to three bouts of 25 minutes the second week. Thereafter, weekly exercise duration will be increased until their target duration of 150 minutes is achieved in week 6. Exercise trainers will assist participants in adjusting exercise routines to achieve their weekly exercise duration goals. Use of equipment, achievement of target HR and safety will be closely monitored by the trainer through the course of the study. Each subject will wear a Polar F4 heart monitor (Polar USA) for recording heart rate during each exercise session. Subjects unable to exercise continuously on the treadmill will perform intermittent training until the target duration is reached. The majority of the exercise sessions will involve walking on a treadmill.
|
Stretching
n=37 Participants
Stretching: This groups intervention is designed to match the aerobic exercise intervention with respect to participation and socialization. Stretching and toning has been repeatedly used as control intervention for exercise studies.The schedule and format will be identical to the aerobic conditioning group to best balance confounding variables such as attention, social interactions, and other unknown variables that might influence the results. An experienced and trained exercise instructor will run the stretching sessions three days a week at the local YMCA. We will monitor changes in heart rate with Polar F4 heart monitors (Polar USA) during the sessions to assess, and minimize, potential aerobic benefits from the intervention.
|
|---|---|---|
|
Disability Assessment for Dementia
Baseline
|
88 percentage on a scale
Standard Deviation 12.3
|
91.2 percentage on a scale
Standard Deviation 8
|
|
Disability Assessment for Dementia
Week 13
|
89.8 percentage on a scale
Standard Deviation 12.5
|
89.5 percentage on a scale
Standard Deviation 12.8
|
|
Disability Assessment for Dementia
Week 26
|
89.5 percentage on a scale
Standard Deviation 13.7
|
86.7 percentage on a scale
Standard Deviation 13.3
|
PRIMARY outcome
Timeframe: Week 0, 13, and 26Population: Linear mixed models were used with all available data. Overall numbers analyzed may not reflect numbers at each timepoint
The Cornell Scale for Depression in Dementia is a validate measure of depressive symptoms in individuals with dementia. Larger numbers indicate greater levels of depression. Scores range from 0 to 38.
Outcome measures
| Measure |
Aerobic Exercise
n=39 Participants
Aerobic Exercise: Participants randomized to this group will perform 150 minutes a week of aerobic exercise over 3-5days. Participants will begin exercising 3 times the first week for 20 minutes, increasing to three bouts of 25 minutes the second week. Thereafter, weekly exercise duration will be increased until their target duration of 150 minutes is achieved in week 6. Exercise trainers will assist participants in adjusting exercise routines to achieve their weekly exercise duration goals. Use of equipment, achievement of target HR and safety will be closely monitored by the trainer through the course of the study. Each subject will wear a Polar F4 heart monitor (Polar USA) for recording heart rate during each exercise session. Subjects unable to exercise continuously on the treadmill will perform intermittent training until the target duration is reached. The majority of the exercise sessions will involve walking on a treadmill.
|
Stretching
n=37 Participants
Stretching: This groups intervention is designed to match the aerobic exercise intervention with respect to participation and socialization. Stretching and toning has been repeatedly used as control intervention for exercise studies.The schedule and format will be identical to the aerobic conditioning group to best balance confounding variables such as attention, social interactions, and other unknown variables that might influence the results. An experienced and trained exercise instructor will run the stretching sessions three days a week at the local YMCA. We will monitor changes in heart rate with Polar F4 heart monitors (Polar USA) during the sessions to assess, and minimize, potential aerobic benefits from the intervention.
|
|---|---|---|
|
Cornell Scale for Depression in Dementia
Baseline
|
7.4 units on a scale
Standard Deviation 3.8
|
8.6 units on a scale
Standard Deviation 5.1
|
|
Cornell Scale for Depression in Dementia
Week 13
|
8.1 units on a scale
Standard Deviation 4.4
|
8.4 units on a scale
Standard Deviation 4.6
|
|
Cornell Scale for Depression in Dementia
Week 26
|
7.8 units on a scale
Standard Deviation 4.4
|
7.8 units on a scale
Standard Deviation 5.2
|
Adverse Events
Aerobic Exercise
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Stretching
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Aerobic Exercise
n=39 participants at risk
Aerobic Exercise: Participants randomized to this group will perform 150 minutes a week of aerobic exercise over 3-5days. Participants will begin exercising 3 times the first week for 20 minutes, increasing to three bouts of 25 minutes the second week. Thereafter, weekly exercise duration will be increased until their target duration of 150 minutes is achieved in week 6. Exercise trainers will assist participants in adjusting exercise routines to achieve their weekly exercise duration goals. Use of equipment, achievement of target HR and safety will be closely monitored by the trainer through the course of the study. Each subject will wear a Polar F4 heart monitor (Polar USA) for recording heart rate during each exercise session. Subjects unable to exercise continuously on the treadmill will perform intermittent training until the target duration is reached. The majority of the exercise sessions will involve walking on a treadmill.
|
Stretching
n=37 participants at risk
Stretching: This groups intervention is designed to match the aerobic exercise intervention with respect to participation and socialization. Stretching and toning has been repeatedly used as control intervention for exercise studies.The schedule and format will be identical to the aerobic conditioning group to best balance confounding variables such as attention, social interactions, and other unknown variables that might influence the results. An experienced and trained exercise instructor will run the stretching sessions three days a week at the local YMCA. We will monitor changes in heart rate with Polar F4 heart monitors (Polar USA) during the sessions to assess, and minimize, potential aerobic benefits from the intervention.
|
|---|---|---|
|
Cardiac disorders
Cardiac
|
20.5%
8/39 • Number of events 8
|
10.8%
4/37 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Muscle soreness or joint pain
|
12.8%
5/39 • Number of events 5
|
13.5%
5/37 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Fall
|
0.00%
0/39
|
2.7%
1/37 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin breakdown
|
5.1%
2/39 • Number of events 2
|
0.00%
0/37
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place