Physical Activity Program for Older Renal Transplant Candidates

NCT00857974 | Completed

• 1 other identifier: IRB00001451
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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. 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. 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

Keywords

Physical Activity; Renal Transplant Candidate; Physical Function; Body Composition

Outcome Measures

Primary Outcomes (1)

• The Short Physical Performance Battery SPPB) score, a brief and simple bedside performance-based instrument.

  One year

Secondary Outcomes (9)

• 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

Study Arms (2)

Usual Care

NO INTERVENTION

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

Physical Activity

ACTIVE COMPARATOR

Other: Physical Activity

Interventions

Physical Activity 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.

Physical Activity

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University: lead
• The John A. Hartford Foundation: collaborator
• Association of Subspecialty Professors: collaborator

Study Sites (1)

Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Stephen Kritchevsky, Ph.D.

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2009
• First Posted: March 9, 2009
• Study Start: July 1, 2007
• Primary Completion: September 1, 2009
• Study Completion: December 1, 2009
• Last Updated: August 15, 2018

Record last verified: 2018-08

Locations

US (1)