Exercise Trial in Chronic Kidney Disease

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2017-10-31

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.

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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.

Conditions

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Chronic Kidney Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Aerobic exercise

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.

Group Type EXPERIMENTAL

Aerobic exercise training

Intervention Type BEHAVIORAL

12 months of aerobic exercise

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.

Group Type ACTIVE_COMPARATOR

Health Education

Intervention Type BEHAVIORAL

12 months of health education sessions

Interventions

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Aerobic exercise training

12 months of aerobic exercise

Intervention Type BEHAVIORAL

Health Education

12 months of health education sessions

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

60 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No