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

NCT06302205 | Recruiting DMC

• 1 other identifier: S66232
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Liver Transplantation; Physical Fitness

Keywords

Exercise Intensity

Outcome Measures

Primary Outcomes (1)

• Cardiorespiratory fitness

  Changes in peak oxygen uptake (mL O2·min-1·kg-1) assessed by cardiopulmonary exercise test

  At 0, 3 and 6 months of the interventional rehabilitation programme and at 15 months after the end of the intervention

Secondary Outcomes (10)

• Functional exercise capacitiy

  At 0, 3 and 6 months of the interventional rehabilitation programme and 15 months after the end of the intervention

• Hand grip strength

  At 0, 3 and 6 months of the interventional rehabilitation programme and 15 months after the end of the intervention

• Knee-extensor strength

  At 0, 3 and 6 months of the interventional rehabilitation programme and 15 months after the end of the intervention

• Endothelial function

  At 0, 3 and 6 months of the interventional rehabilitation programme and 15 months after the end of the intervention

• Arterial stiffness

  At 0, 3 and 6 months of the interventional rehabilitation programme and 15 months after the end of the intervention

Study Arms (3)

Sham Group

SHAM COMPARATOR

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

Other: Sham intervention

Moderate-intensity (MIT)

EXPERIMENTAL

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

Other: Physical activity

Combined moderate and high-intensity (MHIT)

EXPERIMENTAL

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

Other: Physical activity

Interventions

Physical activity 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); Moderate-intensity (MIT)

Sham intervention OTHER

2 times a week, flexibility and balance training

Sham Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• de novo adult liver transplant recipients with a transplant vintage of two to three months
• access to a home freezer (± -18°C)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• KU Leuven: collaborator

Study Sites (1)

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

Related Publications (2)

• Leunis S, Van Criekinge H, Vrancken L, Vandecruys M, Renier M, De Geest S, Bogaerts S, De Smet S, H Van Craenenbroeck A, Monbaliu D, Cornelissen V. Understanding participation of liver transplant recipients in an exercise intervention RCT: a cross-sectional study of barriers and motivators. BMC Sports Sci Med Rehabil. 2025 Nov 10;17(1):324. doi: 10.1186/s13102-025-01369-y.

  PMID: 41214814 DERIVED

• De Smet S, Leunis S, Van Criekinge H, Vandecruys M, Vrancken L, Renier M, Fieuws S, Goetschalckx K, Luyten J, Raes J, Bogaerts S, De Geest S, Van Craenenbroeck AH, Cornelissen V, Monbaliu D. Home-based exercise and PHysical activity maintenance interventiOn after livEr traNsplantation: Impact of eXercise intensity (PHOENIX-Liver). BMJ Open Sport Exerc Med. 2025 Mar 15;11(1):e002436. doi: 10.1136/bmjsem-2024-002436. eCollection 2025.

  PMID: 40098918 DERIVED

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Diethard Monbaliu, MD PhD

CONTACT

+3216342361; diethard.monbaliu@uzleuven.be

Stefan De Smet, PhD

CONTACT

stefan.desmet@kuleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two interventional groups and one control group

Study Record Dates

• First Submitted: December 6, 2023
• First Posted: March 8, 2024
• Study Start: March 1, 2023
• Primary Completion: January 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 1, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)