An interventional study of Physical activity and Sham intervention in Liver Transplantation and Physical Fitness, sponsored by Universitaire Ziekenhuizen KU Leuven. Recruiting at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-01.
Sponsored by Universitaire Ziekenhuizen KU Leuven · Not applicable, Interventional, and Treatment
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.
Liver transplantation constitutes the only curative treatment for patients with end-stage liver disease. Advances in the field have led to favourable short- and medium term (1-3 year) post-transplant survival rates, but improvement in long-term survival rates remains disappointing. Due to the immunosuppressive therapy, a sedentary lifestyle and a poor recovery of post-transplant physical fitness, the proportion of liver transplant recipients that develop a new-onset or a deteriorating unfavourable cardiovascular risk profile is alarmingly high, and cardiovascular disease is the leading cause of death in this population. By consequence, in order to improve long-term outcome after liver transplantation, prevention of cardiovascular disease should be prioritized. The investigators are convinced that the challenge of cardiovascular disease and lack of physical fitness in liver transplant recipients should and can be addressed by subjecting these patients to a structured physical rehabilitation program. The aim of this project is implement a structured, individually-tailored, home-based but supervised physical rehabilitation and maintenance program for de novo liver transplantation recipients, and to demonstrate the feasibility and safety of such approach as well as its efficacy to improve physical fitness. The program will consist of a 2-phase intervention of i) home-based exercise training (aerobic exercise training as well as strength, flexibility and stability exercises under in-person and subsequently remote guidance) and ii) an 15-month maintenance phase of physical activity. This program will be studied in an open-label randomized trial where the regimen will be compared with a regimen of standard of posttransplant care. In addition to the interventional arm, two different regimens of exercise training intensity will also be studied.
Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 928 studies on the registry; 261 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Home-based low-intensity exercise training without subsequent physical activity intervention.
Other: Sham intervention
Home-based moderate-intensity exercise training with subsequent physical activity intervention.
Other: Physical activity
Home-based moderate- and high-intensity exercise training with subsequent physical activity intervention.
Other: Physical activity
The home-based training intervention consists of two phases of each three months in duration. It consists of three weekly aerobic training sessions on the one hand, and two weekly training sessions focused on strength, balance, and flexibility on the other hand.
2 times a week, flexibility and balance training
Cardiorespiratory fitness
Changes in peak oxygen uptake (mL O2·min-1·kg-1) assessed by cardiopulmonary exercise test
Time frame: At 0, 3 and 6 months of the interventional rehabilitation programme and at 15 months after the end of the intervention
Functional exercise capacitiy
six-minute walking test (m)
Time frame: At 0, 3 and 6 months of the interventional rehabilitation programme and 15 months after the end of the intervention
Hand grip strength
assessement by means of Jamar Hydraulic Hand Dynamometry (kg)
Time frame: At 0, 3 and 6 months of the interventional rehabilitation programme and 15 months after the end of the intervention
Knee-extensor strength
assessement by means of Biodex dynamometer (Nm)
Time frame: At 0, 3 and 6 months of the interventional rehabilitation programme and 15 months after the end of the intervention
Endothelial function
assessed via flow mediated dilation
Time frame: At 0, 3 and 6 months of the interventional rehabilitation programme and 15 months after the end of the intervention
Arterial stiffness
assessed via pulse wave velocity
Time frame: At 0, 3 and 6 months of the interventional rehabilitation programme and 15 months after the end of the intervention
Graft function
Transient elastography Fibroscan assessing liver stiffness
Time frame: At 0 and after 21 months
Occurence of adverse events
Safety is estimated by means of questionnaires
Time frame: Monthly
Motor fitness
Short Physical Performance Battery test
Time frame: At 0, 3 and 6 months of the interventional rehabilitation programme and 15 months after the end of the intervention
Blood pressure
Variation in blood pressure measured by means of automatic device (Omron M6) in fasted condition and without medication taken in
Time frame: At 0, 3 and 6 months of the interventional rehabilitation programme and 15 months after the end of the intervention
Blood profile
Blood is drawn when patient is in fasted condition and did not take their medication
Time frame: At 0, 3 and 6 months of the interventional rehabilitation programme, and at 3 and 15 months after the end of the intervention
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Universitaire Ziekenhuizen KU Leuven