Actively Recruiting
A Home-based Exercise and Physical Activity Intervention After Liver Transplantation: Impact of Exercise Intensity
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2024-04-01
147
Participants Needed
1
Research Sites
195 weeks
Total Duration
On this page
Sponsors
U
Universitaire Ziekenhuizen KU Leuven
Lead Sponsor
K
KU Leuven
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Home-based Exercise and Physical Activity Intervention After Liver Transplantation: Impact of Exercise Intensity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- De novo adult liver transplant recipients with a transplant vintage of two to three months
- Access to a home freezer (around -18°C)
You will not qualify if you...
- Aberrant cardiopulmonary exercise test (abnormal low cardiorespiratory fitness is allowed), unstable angina, life-threatening arrhythmias, uncontrolled hypertension or diabetes, HbA1c ≥ 9%, severe pulmonary disease (FEV1 < 50%)
- Musculoskeletal disorders preventing exercise on a cycle ergometer
- Any other medical contraindication for moderate or high-intensity physical exercise as determined by a physician
- Multi-organ transplantation except combined liver-kidney transplant
- Ongoing treatment for malignancies
- Inability to understand Dutch
- No access to smartphone and/or computer with internet
- Unwillingness to accept the general conditions of Coachbox
- Preparticipation medical screening including cardiopulmonary exercise testing and cardiovascular risk assessment is required
AI-Screening
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Trial Site Locations
Total: 1 location
1
UZ Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Actively Recruiting
Research Team
D
Diethard Monbaliu, MD PhD
CONTACT
S
Stefan De Smet, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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