A Home-based Exercise and Physical Activity Intervention After Liver Transplantation: Impact of Exercise Intensity

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Liver Transplantation, Physical Fitness

In brief

Research demonstrated that transplant recipients benefit from physical activity, but there is a gap in knowledge regarding the required intensity. In the PHOENIX-Liver study, researchers aim to investigate the adequate intensity of rehabilitation programs after liver transplantation. Patients will be randomized into one of the three PHOENIX-Liver training groups (low, moderate, moderate to high). The six months rehabilitation program is conducted from the patient's home but supervised by a PHOENIX-investigator. At baseline, after three months of rehabilitation and after six months of rehabilitation, a test moment takes place at which physical fitness, cardiovascular health, liver function, and body composition will be assessed. Questionnaires are taken monthly to survey well-being, safety, quality of life, physical activity, and cost-effectiveness. To gather information on the potential for implementation in a real-world setting, a 15-month-long physical activity phase will start after the intervention phase. This entails a maintenance physical activity program tailored to the patients' preferences. A follow-up at UZ Leuven is planned at three and at 15 months where the same clinical evaluations will be conducted as during the test moments of the intervention phase.

Key facts

Study ID

NCT06302205

Run by

Universitaire Ziekenhuizen KU Leuven

People needed

147

Starts

2023-03-01

Expected to finish

2026-12-01

Last updated by the study team

2024-04-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• de novo adult liver transplant recipients with a transplant vintage of two to three months
• access to a home freezer (± -18°C)

You may not qualify if…

• 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 it is running

• UZ Leuven — Leuven, Vlaams-Brabant, Belgium (enrolling)

Full record on ClinicalTrials.gov

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