Exercise Trial in Chronic Kidney Disease

Chronic Kidney Disease Clinical Trial

— AWARD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01462097
• Other study ID #: HP-00045276
• Secondary ID: 1R01DK090401-01A
• Status: Completed
• Phase: N/A
• Start date: March 2012
• Est. completion date: October 31, 2017

Study information

• Verified date: January 2023
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: October 31, 2017
• Est. primary completion date: October 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Behavioral:
• Aerobic exercise training
12 months of aerobic exercise
• Health Education
12 months of health education sessions

Locations

Country	Name	City	State
United States	Baltimore VA Medical Center / University of Maryland Medical Center	Baltimore	Maryland
United States	Tufts Medical Center	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Peak Aerobic Capacity	VO2peak, measured by Graded Exercise Treadmill Test (GXT) with a modified Balke protocol - higher indicates better aerobic capacity	Baseline, 6 months, 12 months
Primary	Change in 6 Minute Walk	Distance walked in 6 minutes - greater distance represents higher function	Baseline, 6 months, 12 months
Secondary	Change in Physical Function	Timed Up and Go Test	Baseline, 6 months, 12 months
Secondary	Number With Short Physical Performance Battery (SPPB) Score <10 (Out of 12 Maximum)	Short Physical Performance Battery is a test of lower extremity function designed to be administered in older adults, consisting of three components: 1) usual gait speed over a 4-meter course; 2) five repeated chair stands; 3) standing balance battery. Each component is scored 0-4, with higher scores indicating better function, and the total scores of each component are summed (range, 0-12).	Baseline, 6 months, 12 months