Clinical trial NCT01462097: Exercise Trial in Chronic Kidney Disease
Official title: Randomized Trial of Aerobic Exercise Training on Cognitive and Physical Function in Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
Keywords: Chronic kidney disease
Exercise
Aerobic capacity
Learning and memory
Executive function
Endothelial function
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2011-10-28
Enrollment: 99
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Peak Aerobic Capacity
timeFrame: Baseline, 6 months, 12 months
measure: Change in 6 Minute Walk
timeFrame: Baseline, 6 months, 12 months
Secondary outcomes:
measure: Change in Physical Function
timeFrame: Baseline, 6 months, 12 months
measure: Number With Short Physical Performance Battery (SPPB) Score <10 (Out of 12 Maximum)
timeFrame: Baseline, 6 months, 12 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Baltimore VA Medical Center / University of Maryland Medical Center
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
Study officials:
References:
citation: Weiner DE, Liu CK, Miao S, Fielding R, Katzel LI, Giffuni J, Well A, Seliger SL. Effect of Long-term Exercise Training on Physical Performance and Cardiorespiratory Function in Adults With CKD: A Randomized Controlled Trial. Am J Kidney Dis. 2023 Jan;81(1):59-66. doi: 10.1053/j.ajkd.2022.06.008. Epub 2022 Aug 6.