The Efficacy of Physical Activity on Improving Health Outcomes for Renal Transplant Patients and Their Caregivers
Primary Purpose
Chronic Kidney Diseases
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physical Activity Intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Kidney Diseases focused on measuring Exercise, CKD, Graft Survival, Transplant Waitlist
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
Sites / Locations
- UPMC Montefiore Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Patient Physical Activity Arm
Dyadic Physical Activity Arm
Arm Description
Patients only receive physical activity intervention.
Patients and caregivers both receive physical activity intervention.
Outcomes
Primary Outcome Measures
Change of Gate Speed from Baseline vs. 6 months
Measured as meters/second
Secondary Outcome Measures
International Physical Activity Questionnaire
Metabolic Equivalence of Task (MET) to Access Daily Activity Level
Medical Outcome Survey - Short Form 36
Quality of Life Assessment (0 -100)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04054323
Brief Title
The Efficacy of Physical Activity on Improving Health Outcomes for Renal Transplant Patients and Their Caregivers
Official Title
The Efficacy of Physical Activity on Improving Health Outcomes for Renal Transplant Patients and Their Caregivers
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Withdrawn
Why Stopped
no physical therapist available
Study Start Date
April 2021 (Anticipated)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
June 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases
Keywords
Exercise, CKD, Graft Survival, Transplant Waitlist
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patient Physical Activity Arm
Arm Type
Experimental
Arm Description
Patients only receive physical activity intervention.
Arm Title
Dyadic Physical Activity Arm
Arm Type
Experimental
Arm Description
Patients and caregivers both receive physical activity intervention.
Intervention Type
Behavioral
Intervention Name(s)
Physical Activity Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of Gate Speed from Baseline vs. 6 months
Description
Measured as meters/second
Time Frame
Baseline vs. 6 months
Secondary Outcome Measure Information:
Title
International Physical Activity Questionnaire
Description
Metabolic Equivalence of Task (MET) to Access Daily Activity Level
Time Frame
Baseline vs. 6 months
Title
Medical Outcome Survey - Short Form 36
Description
Quality of Life Assessment (0 -100)
Time Frame
Baseline vs. 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Steel, Ph.D.
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
UPMC Montefiore Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Efficacy of Physical Activity on Improving Health Outcomes for Renal Transplant Patients and Their Caregivers
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