Exercise Trial in Chronic Kidney Disease
AWARD
Randomized Trial of Aerobic Exercise Training on Cognitive and Physical Function in Chronic Kidney Disease
2 other identifiers
interventional
99
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2012
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 26, 2011
CompletedFirst Posted
Study publicly available on registry
October 28, 2011
CompletedStudy Start
First participant enrolled
March 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2017
CompletedResults Posted
Study results publicly available
January 25, 2023
CompletedJanuary 25, 2023
January 1, 2023
5.7 years
October 26, 2011
December 9, 2022
January 3, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Change in 6 Minute Walk
Distance walked in 6 minutes - greater distance represents higher function
Baseline, 6 months, 12 months
Secondary Outcomes (2)
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 Arms (2)
Aerobic exercise
EXPERIMENTAL12 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.
Health Education
ACTIVE COMPARATOR12 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.
Interventions
Eligibility Criteria
You may qualify if:
- Stage 3-4 Chronic kidney disease (estimated Glomerular Filtration Rate 15-45)
- Age 60 to 85
- English Speaking
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Baltimore VA Medical Center / University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Related Publications (2)
Liu CK, Miao S, Giffuni J, Katzel LI, Fielding RA, Seliger SL, Weiner DE. Geriatric Syndromes and Health-Related Quality of Life in Older Adults with Chronic Kidney Disease. Kidney360. 2023 Apr 1;4(4):e457-e465. doi: 10.34067/KID.0000000000000078. Epub 2023 Feb 14.
PMID: 36790849DERIVEDWeiner 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.
PMID: 35944747DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
1. Study did not meet accrual target 2. Drop-out and loss to follow-up greater than expected, often to due to intercurrent medical events . 3. Moderately greater loss to follow-up in group randomized to exercise training 4. Lack of blinding of outcome assessors 5. Study not designed to have sufficient power to detect effects on secondary outcomes including kidney function. 6. No adjustment for multiple comparisons - risk of type 1 error may be greater than estimated
Results Point of Contact
- Title
- Stephen Seliger, MD MS
- Organization
- University of Maryland School of Medicine
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Medicine at University of Maryland
Study Record Dates
First Submitted
October 26, 2011
First Posted
October 28, 2011
Study Start
March 1, 2012
Primary Completion
October 31, 2017
Study Completion
October 31, 2017
Last Updated
January 25, 2023
Results First Posted
January 25, 2023
Record last verified: 2023-01