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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

147 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Liver Transplantation Physical Fitness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two interventional groups and one control group

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

The nature of the intervention does not allow blinding of study participants. However, outcome assessors and data investigators will be blinded to the participants' group allocation.

Study Groups

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Sham Group

Home-based low-intensity exercise training without subsequent physical activity intervention.

Group Type SHAM_COMPARATOR

Sham intervention

Intervention Type OTHER

2 times a week, flexibility and balance training

Moderate-intensity (MIT)

Home-based moderate-intensity exercise training with subsequent physical activity intervention.

Group Type EXPERIMENTAL

Physical activity

Intervention Type OTHER

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.

Combined moderate and high-intensity (MHIT)

Home-based moderate- and high-intensity exercise training with subsequent physical activity intervention.

Group Type EXPERIMENTAL

Physical activity

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Sham intervention

2 times a week, flexibility and balance training

Intervention Type OTHER

Eligibility Criteria

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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

* 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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No