Physical Activity Program for Older Renal Transplant Candidates (PART)

Impact of a Physical Activity Intervention on Physical Function and Quality of Life in Aging Candidates for Renal Transplantation: The PART Study

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.

Study Overview

• Status: Completed
• Conditions: Renal Transplant Candidate
• Intervention / Treatment: Other: Physical Activity

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The Short Physical Performance Battery SPPB) score, a brief and simple bedside performance-based instrument.	One year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Wake Forest University
• Collaborators: The John A. Hartford Foundation; Association of Subspecialty Professors
• Investigators: Principal Investigator: Stephen Kritchevsky, Ph.D., Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: March 6, 2009
• First Submitted That Met QC Criteria: March 6, 2009
• First Posted (Estimate): March 9, 2009

Study Record Updates

• Last Update Posted (Actual): August 15, 2018
• Last Update Submitted That Met QC Criteria: August 13, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Physical Activity; Physical Function; Body Composition; Renal Transplant Candidate
• Other Study ID Numbers: IRB00001451

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No