Physical Activity Program for Older Renal Transplant Candidates (PART)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Wake Forest School of Medicine.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
The John A. Hartford Foundation
Association of Subspecialty Professors
Information provided by:
Wake Forest School of Medicine
ClinicalTrials.gov Identifier:
NCT00857974
First received: March 6, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  Purpose

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 Intervention
Renal Transplant Candidate
Other: Physical Activity

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Wake Forest School of Medicine:

Primary Outcome Measures:
  • The Short Physical Performance Battery SPPB) score, a brief and simple bedside performance-based instrument. [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 25
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)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00857974

Locations
United States, North Carolina
Wake Forest University
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest School of Medicine
The John A. Hartford Foundation
Association of Subspecialty Professors
  More Information

No publications provided

Responsible Party: Erica L. Hartmann, MD, Wake Forest University
ClinicalTrials.gov Identifier: NCT00857974     History of Changes
Other Study ID Numbers: IRB00001451
Study First Received: March 6, 2009
Last Updated: March 6, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest School of Medicine:
Physical Activity
Renal Transplant Candidate
Physical Function
Body Composition

ClinicalTrials.gov processed this record on April 17, 2014