Clinical trial NCT00857974: Physical Activity Program for Older Renal Transplant Candidates
Official title: Impact of a Physical Activity Intervention on Physical Function and Quality of Life in Aging Candidates for Renal Transplantation: The PART Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Transplant Candidate
Keywords: Physical Activity
Renal Transplant Candidate
Physical Function
Body Composition
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: The John A. Hartford Foundation
name: Association of Subspecialty Professors
First posted: 2009-03-09
Enrollment: 25
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: The Short Physical Performance Battery SPPB) score, a brief and simple bedside performance-based instrument.
timeFrame: One year
Secondary outcomes:
measure: Health-related quality-of-life scores
timeFrame: One year
measure: Self-reported disability scores
timeFrame: One year
measure: Re-hospitalization
timeFrame: One year
measure: Inter-current illness including cardiovascular events or falls
timeFrame: One year
measure: Endurance
timeFrame: One year
measure: Body composition by both DEXA and thigh CT
timeFrame: One year
measure: Grip strength
timeFrame: One year
measure: Leg strength
timeFrame: One year
measure: ADL disability
timeFrame: One year
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Stephen Kritchevsky, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: