Physical Activity Program for Older Renal Transplant Candidates (PART)
Recruitment status was Active, not recruiting
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:
- 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.
- 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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Impact of a Physical Activity Intervention on Physical Function and Quality of Life in Aging Candidates for Renal Transplantation: The PART Study|
- The Short Physical Performance Battery SPPB) score, a brief and simple bedside performance-based instrument. [ Time Frame: One year ] [ Designated as safety issue: No ]
- Health-related quality-of-life scores [ Time Frame: One year ] [ Designated as safety issue: No ]
- Self-reported disability scores [ Time Frame: One year ] [ Designated as safety issue: No ]
- Re-hospitalization [ Time Frame: One year ] [ Designated as safety issue: No ]
- Inter-current illness including cardiovascular events or falls [ Time Frame: One year ] [ Designated as safety issue: No ]
- Endurance [ Time Frame: One year ] [ Designated as safety issue: No ]
- Body composition by both DEXA and thigh CT [ Time Frame: One year ] [ Designated as safety issue: No ]
- Grip strength [ Time Frame: One year ] [ Designated as safety issue: No ]
- Leg strength [ Time Frame: One year ] [ Designated as safety issue: No ]
- ADL disability [ Time Frame: One year ] [ Designated as safety issue: No ]
|Study Start Date:||July 2007|
|Estimated Study Completion Date:||December 2009|
|Estimated Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
No Intervention: Usual Care
No physical activity intervention will be prescribed for the Usual Care Arm.
|Active Comparator: Physical Activity||
Other: 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00857974
|United States, North Carolina|
|Wake Forest University|
|Winston-Salem, North Carolina, United States, 27157|