The Efficacy of Physical Activity on Improving Health Outcomes for Renal Transplant Patients

NCT ID: NCT04054323

Last Updated: 2024-10-22

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-02
• Study Completion Date: 2023-06-30

Brief Summary

The purpose of this study is to see whether a physical activity intervention improves fitness, strength and reduces sedentary behavior. The investigators are also interested in determining if changes will improve quality of life and outcomes associated with renal transplant waitlist.

Detailed Description

Over 30 million people have chronic kidney disease (CKD) and nearly 100,000 people are awaiting renal transplant for end stage renal disease (ESRD). Renal transplant, when compared to dialysis, improves quality of life, is more cost-effective, and reduces the risk of cardiovascular disease. However, many patients who are eligible for transplant become deconditioned while waiting for organ transplantation, and may be taken off the transplant waitlist for concerns the patient will not be able to tolerate surgery. Moreover, poor physical functioning prior to transplant was associated with a 2.5-fold increased risk for delayed graft function and 2.30 fold higher risk of patient death after renal transplant. Our team has also shown that functional limitations, such as slower gait speed and poorer grip strength, were associated with not being waitlisted for transplant and decreased survival in all transplant candidates undergoing evaluation. Functional limitation may reduce the individuals' overall level of physical activity, which can increase further disability. While physical activity (PA) interventions have been shown to be effective in reducing morbidity and mortality in other chronic diseases, no study has tested the efficacy of a PA intervention in patients awaiting renal transplant. Family caregivers are integral in the care of renal transplant candidates. Decades of research has shown that family caregivers are at increased risk for cardiovascular disease (CVD) and mortality when compared to non-caregivers. Investigators propose to include the family caregivers in the PA intervention to improve patient adherence to the intervention while reducing the caregivers' risk for CVD. The proposed study addresses several of the recommendations from consensus meeting on exercise in solid organ transplant which included testing a PA intervention in a large-scale trial with both standard and surrogate markers, using a novel technology-assisted delivery of the intervention, and focusing on mechanisms linking PA with health outcomes.

Conditions

Chronic Kidney Diseases

Study Design

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

Study Groups

Patient Physical Activity Arm

Patients only receive physical activity intervention.

Group Type: EXPERIMENTAL

Physical Activity Intervention

Intervention Type: BEHAVIORAL

The physical activity intervention will include basic skill training during which the participant will be instructed on the use of (1) the activPAL physical activity device for the tracking of time spent sitting, standing, and walking, (2) tools to monitor exercise intensity, including ratings of perceived exertion, (3) an exercise calendar for setting a specific schedule for the completion of the home exercise program using the exercise videos posted on our website, (4) use of the exercise equipment that will be used in the home program (Therabands), and (5) strategies for reduction of sedentary behavior that target prolonged sitting and encourages frequent activity breaks. Duration of intervention is 6 months.

Dyadic Physical Activity Arm

Patients and caregivers both receive physical activity intervention.

Group Type: EXPERIMENTAL

Physical Activity Intervention

Intervention Type: BEHAVIORAL

The physical activity intervention will include basic skill training during which the participant will be instructed on the use of (1) the activPAL physical activity device for the tracking of time spent sitting, standing, and walking, (2) tools to monitor exercise intensity, including ratings of perceived exertion, (3) an exercise calendar for setting a specific schedule for the completion of the home exercise program using the exercise videos posted on our website, (4) use of the exercise equipment that will be used in the home program (Therabands), and (5) strategies for reduction of sedentary behavior that target prolonged sitting and encourages frequent activity breaks. Duration of intervention is 6 months.

Interventions

Physical Activity Intervention

The physical activity intervention will include basic skill training during which the participant will be instructed on the use of (1) the activPAL physical activity device for the tracking of time spent sitting, standing, and walking, (2) tools to monitor exercise intensity, including ratings of perceived exertion, (3) an exercise calendar for setting a specific schedule for the completion of the home exercise program using the exercise videos posted on our website, (4) use of the exercise equipment that will be used in the home program (Therabands), and (5) strategies for reduction of sedentary behavior that target prolonged sitting and encourages frequent activity breaks. Duration of intervention is 6 months.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Patient:

• Waitlisted for renal transplant
• =>21 years of age
• Caregiver:

• Primary caregiver for patient
• =>21 years of age

Exclusion Criteria

• Patient:

• Active suicidal ideation
• Thought disorder
• Delusions
• Hallucinations
• Recent myocardial infarction, heart attack, or stroke
• Planned elective surgeries for joint replacement
• Caregiver:

• Active suicidal ideation
• Thought disorder
• Delusions
• Hallucinations
• Recent myocardial infarction, heart attack, or stroke
• Planned elective surgeries for joint replacement

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Jennifer Steel

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jennifer Steel, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

UPMC Montefiore Hospital

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

PRO18080372

Identifier Type: -

Identifier Source: org_study_id