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Clinical Trials/NCT04054323
NCT04054323
Withdrawn
N/A

The Efficacy of Physical Activity on Improving Health Outcomes for Renal Transplant Patients and Their Caregivers

University of Pittsburgh1 site in 1 countryApril 2, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Chronic Kidney Diseases
Sponsor
University of Pittsburgh
Locations
1
Primary Endpoint
Change of Gate Speed from Baseline vs. 6 months
Status
Withdrawn
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2, 2021
End Date
June 30, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jennifer Steel

Associate Professor

University of Pittsburgh

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change of Gate Speed from Baseline vs. 6 months

Time Frame: Baseline vs. 6 months

Measured as meters/second

Secondary Outcomes

  • Medical Outcome Survey - Short Form 36(Baseline vs. 6 months)
  • International Physical Activity Questionnaire(Baseline vs. 6 months)

Study Sites (1)

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