A Home-based Exercise and Physical Activity Intervention After Liver Transplantation: Impact of Exercise Intensity - a Monocenter Randomized Controlled Trial [PHOENIX-Liver]

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• de novo adult liver transplant recipients with a transplant vintage of two to three months

• access to a home freezer (± -18°C)

Locations
Other Locations
Belgium
UZ Leuven
RECRUITING
Leuven
Contact Information
Primary
Diethard Monbaliu, MD PhD
diethard.monbaliu@uzleuven.be
+3216342361
Backup
Stefan De Smet, PhD
stefan.desmet@kuleuven.be
Time Frame
Start Date: 2023-03-01
Estimated Completion Date: 2026-12
Participants
Target number of participants: 147
Treatments
Sham_comparator: Sham Group
Home-based low-intensity exercise training without subsequent physical activity intervention.
Experimental: Moderate-intensity (MIT)
Home-based moderate-intensity exercise training with subsequent physical activity intervention.
Experimental: Combined moderate and high-intensity (MHIT)
Home-based moderate- and high-intensity exercise training with subsequent physical activity intervention.
Related Therapeutic Areas
Sponsors
Leads: Universitaire Ziekenhuizen KU Leuven
Collaborators: KU Leuven

This content was sourced from clinicaltrials.gov