Home-based exercise program for liver transplant recipients
A Home-based Exercise and Physical Activity Intervention After Liver Transplantation: Impact of Exercise Intensity - a Monocenter Randomized Controlled Trial [PHOENIX-Liver]
This study is testing whether different levels of exercise at home can help people who have recently had a liver transplant feel better and improve their health over six months.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 147 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 1 site (Leuven, Vlaams-Brabant) |
| Trial ID | NCT06302205 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of different exercise intensities on the rehabilitation of patients who have recently undergone liver transplantation. Participants will be randomly assigned to one of three training groups (low, moderate, or moderate to high intensity) and will engage in a six-month home-based rehabilitation program supervised by a PHOENIX investigator. Assessments of physical fitness, cardiovascular health, liver function, and body composition will occur at baseline, three months, and six months, alongside monthly questionnaires to evaluate well-being and quality of life. The study aims to establish a feasible and effective exercise regimen to improve long-term outcomes for liver transplant recipients.
Who should consider this trial
Good fit: Ideal candidates are de novo adult liver transplant recipients who are two to three months post-transplant and have access to a home freezer.
Not a fit: Patients with severe comorbidities, ongoing malignancies, or those unable to participate in physical exercise due to medical contraindications may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly enhance physical fitness and reduce cardiovascular risks in liver transplant recipients.
How similar studies have performed: Previous studies have shown positive outcomes with structured rehabilitation programs for transplant recipients, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * de novo adult liver transplant recipients with a transplant vintage of two to three months * access to a home freezer (± -18°C) Exclusion Criteria: * Aberrant CPET (abnormal low cardiorespiratory fitness is not considered an exclusion criteria), unstable angina, life-threatening arrhythmias, uncontrolled hypertension/diabetes, HbA1c ≥ 9%, severe pulmonary disease (FEV1 \< 50%), musculoskeletal disorders not allowing physical training on a cycle ergometer, or any other medical reasons by the physician considered to be a contraindication for moderate or high-intensity physical exercise * multi-organ transplantation (exception: combined liver-kidney transplant is considered eligible for participation) * ongoing treatment for malignancies * unable to understand Dutch * no access to smartphone and/or computer with internet access * does not willing to except the general conditions of Coachbox. Preparticipation medical screening (cardiopulmonary exercise testing with 12-lead ECG + stratification of cardiovascular risk factors) will be performed by a cardiologist (Dr. Kaatje Goetschalckx at UZ Leuven).
Where this trial is running
Leuven, Vlaams-Brabant
- UZ Leuven — Leuven, Vlaams-Brabant, Belgium (Recruiting)
Study contacts
- Study coordinator: Diethard Monbaliu, MD PhD
- Email: diethard.monbaliu@uzleuven.be
- Phone: +3216342361
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.