Exercise Trial in Chronic Kidney Disease

Not Applicable

Completed

Interventions: Behavioral: Health Education
Behavioral: Aerobic exercise training

Brief Summary: Chronic Kidney Disease (CKD) is exceedingly common in older adults, in whom it is associated with impairment in cognition and physical function. The purpose of this study is to test the effects of 12 months of aerobic and resistance exercise training compared to health education on cognitive and physical performance in 120 older adults with CKD not requiring dialysis. The results of this study will be essential for demonstrating the effectiveness of exercise in improving function and ultimately preventing disability in this high-risk population of older adults.

Detailed Description: This is a parallel-group randomized controlled trial comparing 12 months of aerobic and resistance exercise training vs. health education (attention control) on neurocognitive and physical performance among community-dwelling older adults (age \>55) and CKD stage 3b and 4. Co-primary outcomes are change in physical performance (including aerobic capacity and submaximal walking) and neurocogntive performance (including executive functions).

Outcome measures will be assessed at baseline and after 6- and 12 months. Exercise training will occur thrice weekly at a dedicated research exercise center and will be supervised by exercise specialists.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Health Education	Health Education	12 months of Health education sessions which will cover topics important to older adults (safe travel, age-appropriate preventative screenings, resources for reliable health information, and topics relevant to chronic kidney disease). For months 1-6 classes will take place 1 time per week. For months 6-12 classes will take place 1 time per month.
Aerobic exercise	Aerobic exercise training	12 months of treadmill walking and strength training exercise. Exercise is gradually progressed in walking speed and time on the treadmill based on the individual's tolerance, abilities, and safety. For months 1-6 exercise will take place 3 times per week at the research center. For months 6-12 exercise will take place 2 times per week at the center and 1 time per week at home.

Primary Outcome Measures

Name	Time	Method
Change in Peak Aerobic Capacity	Baseline, 6 months, 12 months	VO2peak, measured by Graded Exercise Treadmill Test (GXT) with a modified Balke protocol - higher indicates better aerobic capacity
Change in 6 Minute Walk	Baseline, 6 months, 12 months	Distance walked in 6 minutes - greater distance represents higher function

Secondary Outcome Measures

Name	Time	Method
Change in Physical Function	Baseline, 6 months, 12 months	Timed Up and Go Test
Number With Short Physical Performance Battery (SPPB) Score <10 (Out of 12 Maximum)	Baseline, 6 months, 12 months	Short Physical Performance Battery is a test of lower extremity function designed to be administered in older adults, consisting of three components: 1) usual gait speed over a 4-meter course; 2) five repeated chair stands; 3) standing balance battery. Each component is scored 0-4, with higher scores indicating better function, and the total scores of each component are summed (range, 0-12).

Locations (2): Tufts Medical Center
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Boston, Massachusetts, United States
Baltimore VA Medical Center / University of Maryland Medical Center
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Baltimore, Maryland, United States