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This is a small pilot trial of a 5 month aerobic exercise intervention in participants with MCI (n=20) to begin to compare the effects of randomization to use an exercise buddy or to exercise without an assigned buddy. The investigators hypothesize that participants with MCI who exercise with a buddy will have higher adherence to the protocol and greater improvement in 400 meter walk time.
The overall objective of this pilot study is to determine feasibility and gather data that will inform the design of a larger, multicenter, randomized, controlled trial. Specifically, the investigators aim to:
2.1 Determine the feasibility of recruiting persons with MCI and a buddy for an exercise intervention.
- For MCI participants who do not identify a buddy, the investigators will determine the interest and feasibility of recruiting volunteers from the community to be an exercise buddy.
2.2 Determine the effects of having an exercise buddy on:
2.3 Establish a scientific partnership with a community based exercise facility.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Buddy | Active Comparator | Participant will be assigned a buddy that will meet with them at the gym for each of their exercise sessions. This person will serve as a source of support and motivation for them and will also help them remember and stick to the goals set for you. This person will also help them maintain their exercise logs and ensure they are correct. The buddy will not be exercising with them, but will just be there with them while you exercise. |
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| Non Buddy | Placebo Comparator | Participants will not be assigned a buddy (and are not allowed to bring someone with them as a buddy). They will be asked to exercise on their own and remember the goals set for them. They will also be responsible for filling out their own exercise logs and ensuring they are correct. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5-month aerobic exercise intervention | Behavioral | The 5-month aerobic exercise intervention is in accordance with the American Heart Association and American College of Sports Medicine physical activity recommendation for optimizing cardiovascular fitness in older adults.Exercise will consist primarily of walking on the treadmill.The goal of the program will be for participants to exercise at a moderate- to high-intensity, defined as 65-80% (ACSM guidelines) of heart rate reserve (HRR), for 30 minutes, 4 days per week.The duration of exercise will progress from 15-20 mins at 50% HRR the 1st week to 30 mins at 65-80% HRR by the end of the 6th week and thereafter.At the start of each session, exercise intensity will be gradually increased to 50% HRR(0.5[HRmax-HRrest]+HRrest)during a 10minute warmup period,and then to the individualized target heart rate training zone for the next 25-30 minutes.Participants will wear a digital heart rate monitoring device for the duration of the training session. |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence (number of sessions attended and exercise duration in targeted heart rate zone) | This is a pilot study with the principle outcome measures related to recruitment and retention of participants with MCI and buddies and adherence to the protocol. We are specifically interested in:
| 4 times a week for 5 months (each exercise session) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in score on Digit Symbol Coding Test | Baseline 3 months and 5 months | |
| Change in 400m walk time (from randomization to 5 months) | Baseline, 3 months and 5 months | |
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Inclusion Criteria:
Participants:
Buddy:
Exclusion Criteria:
Due to Cognitive Confounders:
Due to increased risk of or low likelihood of compliance with the exercise program:
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| Name | Affiliation | Role |
|---|---|---|
| Laura Baker, Ph.D. | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Baptist Health | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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| Change in Trail Making Test part B score |
| Baseline and 5 months |
| change in memory, measured by Rey AVLT delayed recall score, at 5 months | baseline and 5 months |