The Efficacy of Physical Activity on Improving Health Outcomes for Renal Transplant Patients
- Conditions
- Chronic Kidney Diseases
- Interventions
- Behavioral: Physical Activity Intervention
- Registration Number
- NCT04054323
- Lead Sponsor
- University of Pittsburgh
- Brief Summary
The purpose of this study is to see whether a physical activity intervention improves fitness, strength and reduces sedentary behavior. The investigators are also interested in determining if changes will improve quality of life and outcomes associated with renal transplant waitlist.
- Detailed Description
Over 30 million people have chronic kidney disease (CKD) and nearly 100,000 people are awaiting renal transplant for end stage renal disease (ESRD). Renal transplant, when compared to dialysis, improves quality of life, is more cost-effective, and reduces the risk of cardiovascular disease. However, many patients who are eligible for transplant become deconditioned while waiting for organ transplantation, and may be taken off the transplant waitlist for concerns the patient will not be able to tolerate surgery. Moreover, poor physical functioning prior to transplant was associated with a 2.5-fold increased risk for delayed graft function and 2.30 fold higher risk of patient death after renal transplant. Our team has also shown that functional limitations, such as slower gait speed and poorer grip strength, were associated with not being waitlisted for transplant and decreased survival in all transplant candidates undergoing evaluation. Functional limitation may reduce the individuals' overall level of physical activity, which can increase further disability. While physical activity (PA) interventions have been shown to be effective in reducing morbidity and mortality in other chronic diseases, no study has tested the efficacy of a PA intervention in patients awaiting renal transplant. Family caregivers are integral in the care of renal transplant candidates. Decades of research has shown that family caregivers are at increased risk for cardiovascular disease (CVD) and mortality when compared to non-caregivers. Investigators propose to include the family caregivers in the PA intervention to improve patient adherence to the intervention while reducing the caregivers' risk for CVD. The proposed study addresses several of the recommendations from consensus meeting on exercise in solid organ transplant which included testing a PA intervention in a large-scale trial with both standard and surrogate markers, using a novel technology-assisted delivery of the intervention, and focusing on mechanisms linking PA with health outcomes.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Patient Physical Activity Arm Physical Activity Intervention Patients only receive physical activity intervention. Dyadic Physical Activity Arm Physical Activity Intervention Patients and caregivers both receive physical activity intervention.
- Primary Outcome Measures
Name Time Method Change of Gate Speed from Baseline vs. 6 months Baseline vs. 6 months Measured as meters/second
- Secondary Outcome Measures
Name Time Method Medical Outcome Survey - Short Form 36 Baseline vs. 6 months Quality of Life Assessment (0 -100)
International Physical Activity Questionnaire Baseline vs. 6 months Metabolic Equivalence of Task (MET) to Access Daily Activity Level
Trial Locations
- Locations (1)
UPMC Montefiore Hospital
🇺🇸Pittsburgh, Pennsylvania, United States