Understanding participation of liver transplant recipients in an exercise intervention RCT: a cross-sectional study of barriers and motivators.
Sofie Leunis, Hanne Van Criekinge, Lieze Vrancken...
https://pubmed.ncbi.nlm.nih.gov/41214814Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06302205
A Home-based Exercise and Physical Activity Intervention After Liver Transplantation: Impact of Exercise Intensity - a Monocenter Randomized Controlled Trial [PHOENIX-Liver]
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2024-04-01
147
Participants Needed
1
Research Sites
47 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
Researchers are investigating the appropriate intensity of rehabilitation programs for patients who have undergone liver transplantation. Cardiovascular disease is a leading cause of death for these patients due to sedentary lifestyle and poor physical fitness after transplant. The study aims to test a structured, home-based, supervised physical rehabilitation and maintenance program in liver transplant recipients, assessing its feasibility, safety, and ability to improve physical fitness. Participants will be randomly assigned to one of three training groups with different exercise intensities: low, moderate, or combined moderate and high intensity. The rehabilitation program lasts six months and includes aerobic, strength, balance, and flexibility exercises performed from home under supervision. After this, a 15-month maintenance phase of physical activity tailored to individual preferences will follow to observe long-term implementation. Participants will undergo assessments at the start, three months, six months, and 15 months after the intervention begins. These evaluations include tests of physical fitness, cardiovascular health, liver function, body composition, and questionnaires monitoring well-being, safety, quality of life, physical activity, and cost-effectiveness. Monthly monitoring of adverse events and follow-ups at the study site will ensure safety and track outcomes over time.
CONDITIONS
Brief Title
A Home-based Exercise and Physical Activity Intervention After Liver Transplantation: Impact of Exercise Intensity
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adult liver transplant recipients 2 to 3 months after transplant
- Access to a home freezer (-18°C)
You will not qualify if you...
- Unstable angina or life-threatening arrhythmias
- Uncontrolled hypertension or diabetes with HbA1c ≥ 9%
- Severe lung disease (FEV1 < 50%)
- Musculoskeletal disorders preventing cycle ergometer training
- Other medical reasons contraindicating moderate or high-intensity exercise
- Multi-organ transplant except combined liver-kidney transplant
- Current treatment for cancer
- Unable to understand Dutch
- No access to smartphone or computer with internet
- Unwilling to accept general conditions of Coachbox
- Contraindications found in preparticipation medical screening including cardiopulmonary exercise testing and cardiovascular risk stratification
- Ongoing multi-organ transplantation except liver-kidney transplants
- Ongoing malignancy treatments
- No internet-enabled device access
- Language barrier or refusal of study conditions
- Medical contraindications for exercise as determined by physician
- Musculoskeletal limitations preventing exercise on cycle ergometer
- Severe pulmonary disease with FEV1 less than 50%
- Cardiovascular instability such as uncontrolled hypertension or serious arrhythmias
- HbA1c greater than or equal to 9%
- Unable to participate due to any other medical reason per physician judgment
- Not willing to accept study conditions
- Unable to understand Dutch language
- No access to required technology
- Multi-organ transplantation except combined liver-kidney transplant
- Ongoing cancer treatment
- Medical screening contraindications
AI-Screening
AI-Powered Screening
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1
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3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 6 months
Participants engage in a home-based exercise training program consisting of two phases of three months each. The program includes three weekly aerobic sessions and two weekly sessions focusing on strength, balance, and flexibility. Different exercise intensities are studied.
Weekly visits for monitoring and guidance
Follow-up
Duration - 15 months
Participants continue a 15-month maintenance phase of physical activity to support long-term fitness after the intervention.
Monthly visits for assessment
Trial Site Locations
Total: 1 location
1
UZ Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Actively Recruiting
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Research Team
D
Diethard Monbaliu, MD PhD
S
Stefan De Smet, PhD
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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Published Research Related To This Trial
Home-based exercise and PHysical activity maintenance interventiOn after livEr traNsplantation: Impact of eXercise intensity (PHOENIX-Liver).
Stefan De Smet, Sofie Leunis, Hanne Van Criekinge...
https://pubmed.ncbi.nlm.nih.gov/40098918