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Clinical Trials/NCT01462097
NCT01462097
Completed
Not Applicable

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

University of Maryland, Baltimore2 sites in 1 country99 target enrollmentMarch 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Kidney Disease
Sponsor
University of Maryland, Baltimore
Enrollment
99
Locations
2
Primary Endpoint
Change in Peak Aerobic Capacity
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2012
End Date
October 31, 2017
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Stephen Seliger

Associate Professor of Medicine at University of Maryland

University of Maryland, Baltimore

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

Outcomes

Primary Outcomes

Change in Peak Aerobic Capacity

Time Frame: Baseline, 6 months, 12 months

VO2peak, measured by Graded Exercise Treadmill Test (GXT) with a modified Balke protocol - higher indicates better aerobic capacity

Change in 6 Minute Walk

Time Frame: Baseline, 6 months, 12 months

Distance walked in 6 minutes - greater distance represents higher function

Secondary Outcomes

  • Change in Physical Function(Baseline, 6 months, 12 months)
  • Number With Short Physical Performance Battery (SPPB) Score <10 (Out of 12 Maximum)(Baseline, 6 months, 12 months)

Study Sites (2)

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