An Exercise and Wellness Behavior Change Program for Solid Organ Transplant: A Clinical Research Protocol for the Transplant Wellness Program.
Jenna A P Sim, Maneka A Perinpanayagam, Vanessa Bahry...
https://pubmed.ncbi.nlm.nih.gov/39449962Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06367244
Exercise and Wellness Behaviour Change for Solid Organ Transplant Patients: A Hybrid Effectiveness-Implementation Trial of the Transplant Wellness Program
Led by University of Calgary · Updated on 2026-04-29
420
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the Transplant Wellness Program (TWP), a multiphase exercise and wellness behavior change program designed for kidney and liver transplant patients. The study focuses on improving physical activity, mental health, and overall quality of life (QoL) before and after transplant surgery. The TWP combines exercise with wellness components such as nutrition, stress reduction, and sleep support, to promote long-term lifestyle changes and reduce healthcare use including hospital admissions and emergency visits. Participants will engage in a 12-week exercise intervention either before or after transplant surgery, tailored to individual needs and including both individual and group sessions. The program uses a multimodal exercise approach following chronic disease guidelines, with activities adjusted for participants' fitness and health status. Alongside exercise, wellness behavior support and resources like group classes and webinars are provided. The study evaluates outcomes using the RE-AIM framework, focusing on program reach, effectiveness, adoption, implementation, and maintenance. Participants will complete functional fitness assessments and patient-reported outcome questionnaires at multiple points: before intervention, immediately after the 12-week exercise program, 12 weeks post-transplant, and at 6 months and 1 year post-intervention. Assessments include measures of frailty, physical fitness, quality of life, nutrition, sleep, and mental health. Data on healthcare use and medication will also be collected. Feedback on participant experience will be gathered through surveys and interviews, with long-term follow-up extending up to 5 years.
CONDITIONS
Brief Title
Transplant Wellness Program
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Currently being evaluated or listed (active or temporarily inactive) on the kidney or liver transplant waiting list (status 0, 1, or 2)
- Able to provide written informed consent and understand study information in English
- Approval to exercise from a Clinical Exercise Physiologist
- Have access to an internet-connected device
You will not qualify if you...
- Not cleared for participation in the Transplant Wellness Program by attending physician
- Unable to provide informed consent
- Clinical condition making participation unsafe or infeasible (e.g., refractory encephalopathy)
- Unsafe environment for virtual participation
- Recent variceal bleeding with intolerance to prophylaxis using non-selective beta blockers
AI-Screening
AI-Powered Screening
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1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or online)
Exercise Intervention
Duration - 12 weeks
Participants engage in a 12-week exercise program tailored to their needs, delivered through individual and group sessions either in-person or online to support physical activity and wellness behaviour change before or after transplant surgery.
24 individual and group sessions combined (in-person or online)
Post-Transplant Surgery Assessment
Duration - 12 weeks post-transplant
Participants complete functional fitness assessments and wellness behaviour support after transplant surgery to monitor recovery and progress.
1 assessment visit (in-person or online)
Follow-up Assessments
Duration - Up to 5 years
Participants complete follow-up functional fitness assessments and patient-reported outcome questionnaires at multiple time points to evaluate long-term wellness and quality of life.
Assessments at 6 months, 1 year, and annually up to 5 years (mostly online)
Trial Site Locations
Total: 1 location
1
University of Calgary
Calgary, Alberta, Canada, T2N 1N4
Actively Recruiting
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Research Team
M
Maneka Perinpanayagam, PhD
S
Stefan Mustata, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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