Exercise Trial in Chronic Kidney Disease (AWARD)

University of Maryland Baltimore (UMB)

Status: Completed

Conditions: Chronic Kidney Disease

Treatments: Behavioral: Aerobic exercise training; Behavioral: Health Education

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01462097

HP-00045276

1R01DK090401-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 99 patients

Sex: All

Ages: 60 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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99 participants in 2 patient groups

Aerobic exercise

Experimental group

Description:

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.

Treatment:

Behavioral: Aerobic exercise training

Health Education

Active Comparator group

Description:

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.

Treatment:

Behavioral: Health Education