Online prehabilitation program for liver transplant patients
OPAL: Online Prehabilitation for Patients Awaiting Liver Transplantation - a Multicenter Randomized Controlled Trial to Reduce Physical Frailty and Improve Health Outcomes
This study tests whether a 12-week online program that includes exercise and nutrition can help people waiting for a liver transplant feel stronger and healthier.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 177 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Alberta Academic / other |
| Locations | 6 sites (Calgary, Alberta and 5 other locations) |
| Trial ID | NCT05899231 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a 12-week online prehabilitation program designed for patients awaiting liver transplantation. The program includes nutritional guidance and resistance exercise, aiming to improve physical function and overall health outcomes for individuals with cirrhosis. Participants will be recruited from five major transplant centers across Canada and will be randomized to either the prehabilitation program or usual care. The primary outcome will measure the change in distance walked in six minutes, while secondary outcomes will assess various health-related metrics.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with cirrhosis who are pre-frail or frail and have a high likelihood of being listed for liver transplantation.
Not a fit: Patients who are robust on frailty testing or have a life expectancy of less than six months may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could enhance physical function and health outcomes for patients awaiting liver transplantation.
How similar studies have performed: Previous smaller studies have shown promising results for prehabilitation in improving physical function in similar patient populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: ≥18 years old with cirrhosis (confirmed with transient elastography by FibroScan, histology, or imaging-based assessment with compatible clinical picture), referred for transplant and are assessed to have a high likelihood of being listed according to a preliminary review by hepatologist or are already listed for LT, are pre-frail or frail on the liver frailty index (LFI) or (added August 30, 2024) pre-frail or frail on the TeLeFI (prefrail LFI 3.2-4.3 and frail LFI ≥4.4), have English or French language proficiency, and own an internet-connected device. Exclusion Criteria: * Listed for living related donor transplantation with expected time on the wait list \<12 weeks, or model for end-stage liver disease (MELD-Na) Score \>26 (Justification: time to transplant is very short) * Robust status on frailty testing (LFI 0-3.1) (Justification: unlikely to see benefit) * Unable to provide informed consent * Presence of a clinical condition that makes the intervention unsafe or infeasible (e.g. unable to follow instruction) or unsafe environment for virtual participation * Life expectancy less than 6 months, compassionate care (clinician judgment) (Justification: unlikely to see benefit) * Recent variceal bleed or history of varices not on adequate prophylaxis (Justification: acute exercise increases portal pressure * Transplant indication is cholangiocarcinoma.
Where this trial is running
Calgary, Alberta and 5 other locations
- Foothills Medical Centre — Calgary, Alberta, Canada (Recruiting)
- Kaye Edmonton Clinic — Edmonton, Alberta, Canada (Recruiting)
- Gordon and Leslie Diamond Health Care Centre — Vancouver, British Columbia, Canada (Recruiting)
- London Health Sciences Centre — London, Ontario, Canada (Recruiting)
- Toronto General Hospital - Ajmera Transplant Centre — Toronto, Ontario, Canada (Recruiting)
- McGill University Health Centre — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Puneeta Tandon — University of Alberta
- Study coordinator: Puneeta Tandon
- Email: ptandon@ualberta.ca
- Phone: 780-492-9844
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.