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

University of Pittsburgh logo

University of Pittsburgh

Status

Withdrawn

Conditions

Chronic Kidney Diseases

Treatments

Behavioral: Physical Activity Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT04054323
PRO18080372

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups

Patient Physical Activity Arm
Experimental group
Description:
Patients only receive physical activity intervention.
Treatment:
Behavioral: Physical Activity Intervention
Dyadic Physical Activity Arm
Experimental group
Description:
Patients and caregivers both receive physical activity intervention.
Treatment:
Behavioral: Physical Activity Intervention

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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