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

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.

Study Overview

• Status: Withdrawn
• Conditions: Chronic Kidney Diseases
• Intervention / Treatment: Behavioral: Physical Activity Intervention

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC Montefiore Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient Physical Activity Arm; Patients only receive physical activity intervention.	Behavioral: 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.
Experimental: Dyadic Physical Activity Arm; Patients and caregivers both receive physical activity intervention.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Gate Speed from Baseline vs. 6 months	Measured as meters/second	Baseline vs. 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
International Physical Activity Questionnaire	Metabolic Equivalence of Task (MET) to Access Daily Activity Level	Baseline vs. 6 months
Medical Outcome Survey - Short Form 36	Quality of Life Assessment (0 -100)	Baseline vs. 6 months

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Investigators: Principal Investigator: Jennifer Steel, Ph.D., University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2021
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: August 9, 2019
• First Submitted That Met QC Criteria: August 9, 2019
• First Posted (Actual): August 13, 2019

Study Record Updates

• Last Update Posted (Actual): May 6, 2021
• Last Update Submitted That Met QC Criteria: May 3, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Exercise; CKD; Graft Survival; Transplant Waitlist
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: PRO18080372

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No