Physical Activity Program for Older Renal Transplant Candidates

NCT ID: NCT00857974

Last Updated: 2018-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2009-12-31

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.

Conditions

Renal Transplant Candidate

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Usual Care

No physical activity intervention will be prescribed for the Usual Care Arm.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Physical Activity

Group Type: ACTIVE_COMPARATOR

Physical Activity

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The John A. Hartford Foundation

OTHER

Sponsor Role: collaborator

Association of Subspecialty Professors

OTHER

Sponsor Role: collaborator

Wake Forest University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen Kritchevsky, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest University

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

IRB00001451

Identifier Type: -

Identifier Source: org_study_id