Overview

This trial is active, not recruiting.

Condition renal transplant candidate
Treatment physical activity
Sponsor Wake Forest School of Medicine
Collaborator The John A. Hartford Foundation
Start date July 2007
End date September 2009
Trial size 25 participants
Trial identifier NCT00857974, IRB00001451

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(No Intervention)
No physical activity intervention will be prescribed for the Usual Care Arm.
(Active Comparator)
physical activity
The intervention is an individualized, structured, moderate intensity home-based physical activity program. During the first 12 weeks the program will focus on lower extremity strengthening, and thereafter incorporate cardiovascular activity. The target duration of activity is 150 minutes per week, i.e., 20-30 min on most days of the week. However, the program is adjusted based on each participant's progression, initial level of physical fitness and will be modified in response to illness, injury, or physical symptoms.

Primary Outcomes

Measure
The Short Physical Performance Battery SPPB) score, a brief and simple bedside performance-based instrument.
time frame: One year

Secondary Outcomes

Measure
Health-related quality-of-life scores
time frame: One year
Self-reported disability scores
time frame: One year
Re-hospitalization
time frame: One year
Inter-current illness including cardiovascular events or falls
time frame: One year
Endurance
time frame: One year
Body composition by both DEXA and thigh CT
time frame: One year
Grip strength
time frame: One year
Leg strength
time frame: One year
ADL disability
time frame: One year

Eligibility Criteria

Male or female participants at least 60 years old.

Inclusion Criteria: - 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 Exclusion Criteria: - 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

Additional Information

Official title Impact of a Physical Activity Intervention on Physical Function and Quality of Life in Aging Candidates for Renal Transplantation: The PART Study
Trial information was received from ClinicalTrials.gov and was last updated in March 2009.
Information provided to ClinicalTrials.gov by Wake Forest School of Medicine.