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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
101
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.
University of Kansas Medical Center
Kansas City, Kansas, United States
Visuospatial Processing
Visuospatial Processing is a latent derived variable derived estimated mean.The reported latent means for this trial are created from the well-known neuropsychological tests: Block Design, Stroop Color Reading, Digit Symbol Substitution and Trailmaking Test A. Latent variables cannot be measured directly but are derived from a theory-driven confirmatory factor analysis in a structural equation model framework. The latent 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. Positive number indicate improved performance. Negative numbers indicate worsening performance.
Time frame: 26 weeks
Change in Maximal Oxygen Consumption
Maximal Oxygen consumption (VO2 max) is the standard, quantitative measure of aerobic fitness. The physiologic range of scores is approximately 3.5 milliliters of oxygen per kilogram of body weight per minute (ml/kg/min) to approximately 90 (ml/kg/min). Higher numbers indicate greater fitness and positive change indicates increasing fitness. Lower number indicate worse fitness
Time frame: 26 weeks
Change in Physical Performance Test
The Physical Performance Test is a 9-item measure of physical function. The range of scores is 0-34. Higher numbers indicate better physical function. Positive change indicates improving function. Negative change indicates decreasing function.
Time frame: 26 Week
Verbal Memory
Verbal Memory is a latent derived variable derived estimated mean. The reported latent means for this trial are created from the well-known neuropsychological tests: Logical Memory, Delayed Logical Memory, Selective Reminding Task - Free Recall Total, Boston Naming Test. Latent variables cannot be measured directly but are derived from a theory-driven confirmatory factor analysis in a structural equation model framework. The latent 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. Positive number indicate improved performance.Negative numbers indicate worsening performance.
Time frame: 26 weeks
Simple Attention
Simple Attention is a latent derived variable derived estimated mean. The reported latent means for this trial are created from the well-known neuropsychological tests: Digit span Forward and Backward, Letter Numbers Sequencing. Latent variables cannot be measured directly but are derived from a theory-driven confirmatory factor analysis in a structural equation model framework. The latent 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. Positive number indicate improved performance. Negative numbers indicate worsening performance.
Time frame: 26 Weeks
Set Maintenance & Shifting
Set Maintenance and Switching is a latent derived variable derived estimated mean. The reported latent means for this trial are created from the well-known neuropsychological tests: DKEFS Card Sort, Animal and Vegetable Category Fluency. Latent variables cannot be measured directly but are derived from a theory-driven confirmatory factor analysis in a structural equation model framework. The latent 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. Positive number indicate improved performance. Negative numbers indicate worsening performance.
Time frame: 26 Weeks
Reasoning
Reasoning is a latent derived variable derived estimated mean. The reported latent means for this trial are created from the well-known neuropsychological tests:Letter and Word Inductive Reasoning, Matrix Reasoning. Latent variables cannot be measured directly but are derived from a theory-driven confirmatory factor analysis in a structural equation model framework. The latent 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. Positive number indicate improved performance. Negative numbers indicate worsening performance.
Time frame: 26 Weeks
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