Physical Activity Program for Older Renal Transplant Candidates (PART)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00857974
Recruitment Status : Completed
First Posted : March 9, 2009
Last Update Posted : November 6, 2017
The John A. Hartford Foundation
Association of Subspecialty Professors
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )

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.

Condition or disease Intervention/treatment
Renal Transplant Candidate Other: Physical Activity

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : July 2007
Primary Completion Date : September 2009
Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.

Primary Outcome Measures :
  1. The Short Physical Performance Battery SPPB) score, a brief and simple bedside performance-based instrument. [ Time Frame: One year ]

Secondary Outcome Measures :
  1. Health-related quality-of-life scores [ Time Frame: One year ]
  2. Self-reported disability scores [ Time Frame: One year ]
  3. Re-hospitalization [ Time Frame: One year ]
  4. Inter-current illness including cardiovascular events or falls [ Time Frame: One year ]
  5. Endurance [ Time Frame: One year ]
  6. Body composition by both DEXA and thigh CT [ Time Frame: One year ]
  7. Grip strength [ Time Frame: One year ]
  8. Leg strength [ Time Frame: One year ]
  9. ADL disability [ Time Frame: One year ]

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00857974

United States, North Carolina
Wake Forest University
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University
The John A. Hartford Foundation
Association of Subspecialty Professors
Principal Investigator: Stephen Kritchevsky, Ph.D. Wake Forest University Health Sciences

Responsible Party: Wake Forest University Identifier: NCT00857974     History of Changes
Other Study ID Numbers: IRB00001451
First Posted: March 9, 2009    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: January 2017

Keywords provided by Wake Forest University Health Sciences ( Wake Forest University ):
Physical Activity
Renal Transplant Candidate
Physical Function
Body Composition