Exercise Trial in Chronic Kidney Disease (AWARD)
|Chronic Kidney Disease||Behavioral: Aerobic exercise training Behavioral: Health Education|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
|Official Title:||Randomized Trial of Aerobic Exercise Training on Cognitive and Physical Function in Chronic Kidney Disease|
- Change in neurocognitive function [ Time Frame: Baseline, 6 months, 12 months ]Executive function, psychomotor speed, memory, learning
- Change in peak aerobic capacity [ Time Frame: Baseline, 6 months, 12 months ]VO2peak
- Change in 6 minute walk [ Time Frame: Baseline, 6 months, 12 months ]Distance walked in 6 minutes
- Change in physical Function [ Time Frame: Baseline, 6 months, 12 months ]Short Physical Performance Battery, Knee extensor strength, Timed get up and go
- Change in endothelial function [ Time Frame: Baseline, 6 months, 12 months ]Microvascular function using Laser Doppler Flowmetry.
- Change in health-related quality of life [ Time Frame: Baseline, 6 months, 12 months ]Various questionnaires including the Medical Outcomes Short Form-36, Memorial Symptom Assessment Scale Short Form, and the Beck Depression Inventory
- Change in cardiovascular disease risk factors [ Time Frame: Baseline, 6 months, 12 months ]Blood pressure and various blood draw values
|Study Start Date:||March 2012|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Experimental: 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.
Behavioral: Aerobic exercise training
12 months of aerobic exercise
Active Comparator: 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.
Behavioral: Health Education
12 months of health education sessions
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 neurocogntivie 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01462097
|Contact: Dr. Stephen L Seliger, MD, MS||410-605-7000 ext firstname.lastname@example.org|
|United States, Maryland|
|Baltimore VA Medical Center / University of Maryland Medical Center||Recruiting|
|Baltimore, Maryland, United States, 21201|
|Contact: Dr. Stephen L Seliger, MD, MS 410-605-7000 ext 4840|
|Principal Investigator: Dr. Stephen L Seliger, MD, MS|
|Sub-Investigator: Dr. Leslie I Katzel, MD, PhD|
|United States, Massachusetts|
|Tufts Medical Center||Recruiting|
|Boston, Massachusetts, United States, 02111|
|Contact: Andrew Well 617-636-2574|
|Principal Investigator: Dr. Daniel Weiner, MD|