At a glance
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Dose Response Study of Exercise for Age-related Cognitive Changes
In Brief
A Early Phase 1 clinical trial evaluating Nonexercise control group, Aerobic Exercise Group 1, and 2 other interventions for Alzheimer's Disease. Completed, enrolled 101 participants across 1 site.
Detailed Summary
This is a randomized, 26-week study of supervised exercise assessing three doses of exercise in sedentary individuals 65 years of age and over with age-related cognitive changes. A total of 100 subjects (n=25 in each of four groups) will be randomized to a non-aerobic control group, 75 minutes, 150 minutes, or 225 minutes a week of moderate intensity aerobic exercise spread over 3 to 5 days a week for 26 weeks. These exercise doses represent 50%, 100%, or 150% of the recommended exercise dose. Participants will be directly supervised during all exercise sessions for the first two months after which direct supervision will occur during at least one session a week. This is intended to provide increased flexibility while also maintaining direct contact with the participant to enhance adherence. Aerobic fitness, physical function, and cognition will be assessed at baseline and 26 weeks to examine the dose-response relationships.
Study Details
Timeline
Interventions
Participants randomized to the nonexercise control group will be asked to maintain their current level of physical activity during the 26-week active study period. They will perform outcome assessments and receive the same telephone checks as the exercise group at baseline, 26 and 52 weeks. The purpose of including a non-exercise control group is to allow adequate comparisons with the low, medium and high exercise dose groups on changes in cognitive and physiologic outcome measures.
The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days.
The 100% group will perform 150 minutes a week of exercise over 3 - 5 days
The 150% group will perform 225 minutes a week of exercise over 4 - 5 days.