Clinical trial NCT04054323: The Efficacy of Physical Activity on Improving Health Outcomes for Renal Transplant Patients
Official title: The Efficacy of Physical Activity on Improving Health Outcomes for Renal Transplant Patients and Their Caregivers
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Chronic Kidney Diseases
Keywords: Exercise
CKD
Graft Survival
Transplant Waitlist
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2019-08-13
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change of Gate Speed from Baseline vs. 6 months
timeFrame: Baseline vs. 6 months
Secondary outcomes:
measure: International Physical Activity Questionnaire
timeFrame: Baseline vs. 6 months
measure: Medical Outcome Survey - Short Form 36
timeFrame: Baseline vs. 6 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Montefiore Hospital
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Jennifer Steel, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: