Exercise Trial in Chronic Kidney Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Trial of Aerobic Exercise Training on Cognitive and Physical Function in Chronic Kidney Disease

Conditions
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Chronic Kidney Disease

Intervention / Treatment
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* Behavioral: Aerobic exercise training
* Behavioral: Health Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stage 3-4 Chronic kidney disease (estimated Glomerular Filtration Rate 15-45) Age 60 to 85 English Speaking Exclusion Criteria: Dementia or cognitive impairment Renal transplant New York Heart Association class 3-4 heart failure Severe Chronic Lung Disease Unstable angina or coronary revascularization within the last 3 months Orthopedic problems that would preclude aerobic exercise training Known, untreated infection Disabling arthritis Uncontrolled arrhythmia More than 14 alcoholic drinks per week

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aerobic exercise<br>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. | Behavioral: Aerobic exercise training<br>* 12 months of aerobic exercise<br>|
| Active Comparator: Health Education<br>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. | Behavioral: Health Education<br>* 12 months of health education sessions<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Physical Function | Timed Up and Go Test | Baseline, 6 months, 12 months | 
| Number With Short Physical Performance Battery (SPPB) Score <10 (Out of 12 Maximum) | 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). | Baseline, 6 months, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise, Chronic kidney disease, Aerobic capacity, Learning and memory, Executive function, Endothelial function