Physical Activity Program for Older Renal Transplant Candidates

Completed · Not applicable

Conditions studied: Renal Transplant Candidate

In brief

The physical function of older candidates for renal transplantation and their ability to sustain physical activity programs are currently unknown. The primary goal of this study is to determine the feasibility of a physical activity intervention in older dialysis-dependent patients, assessing its effect on maintaining transplant candidacy and outcome after transplantation. Clinical practice guidelines do not set an absolute age limit for evaluating potential renal transplant candidates. While cardiovascular risk assessment and malignancy screening are emphasized in the older age group, physical performance and the risk for disability are often overlooked. Although healthy older patients experience increased life expectancy after renal transplantation versus remaining on dialysis, outcomes such as the capacity to live independently and function well have not been studied. Given the poorer baseline health status in aging end-stage renal disease patients, rapid changes in health on dialysis, and the national organ shortage, it is increasingly important to identify factors that predict better outcomes and devise strategies that will maximize the benefit of transplantation in older individuals. The investigators hypothesize that muscle is the principal organ system underlying impaired physical function among older transplant candidates, and that decreased muscle mass and physical functioning lead to poorer outcomes in older renal transplant candidates. The investigators propose that a simple bedside performance measurement of lower extremity functional limitations, the Short Physical Performance Battery, will be a strong predictor of outcomes in this patient cohort. The investigators also propose that outcomes can be improved with exercise training, potentially leading to longer durations of active transplant candidacy and greater independence after successful transplantation. The Specific Aims of this research are: 1. Determine the feasibility of an exercise intervention in dialysis-dependent wait-listed patients age 60 years and over who will be randomized to one of two groups: usual care versus a structured physical activity program. 2. Define the natural history of physical function in patients age 60 years and greater who remain on dialysis or undergo renal transplantation attempting to identify a subgroup of older wait listed patients who are at high risk for developing disability.

Key facts

Study ID

NCT00857974

Run by

Wake Forest University

People needed

25

Starts

2007-07-01

Expected to finish

2009-12-01

Last updated by the study team

2018-08-15

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 60 years
• Listed on the renal transplant waiting list (either active or inactive status)
• Able to give consent
• Able to maintain sitting or standing balance and ambulate without assistance from another person

You may not qualify if…

• MMSE score less than 21
• Unstable coronary artery disease
• Less than three months since the patient had a myocardial infarction
• Congestive heart failure NY class III or IV
• Lower extremity amputation without prosthesis
• Severe and active lower extremity musculoskeletal problem which prevents participation in the intervention
• Individuals who are more active than the intervention and thus would not be likely to benefit
• SPPB score of 12 (the maximum score) at screening

Where it is running

• Wake Forest University — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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