Liver TransplantationPHOENIX-LNCT06302205
A Home-based Exercise and Physical Activity Intervention After Liver Transplantation: Impact of Exercise Intensity
A study testing Physical activity in people with Liver Transplantation and Physical Fitness, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplantation, Physical Fitness
- What is being tested?
- Physical activity
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 147 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Mar 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- de novo adult liver transplant recipients with a transplant vintage of two to three months
- access to a home freezer (± -18°C)
Who cannot join
- Aberrant CPET (abnormal low cardiorespiratory fitness is not considered an exclusion criteria), unstable angina, life-threatening arrhythmias, uncontrolled hypertension/diabetes, HbA1c ≥ 9%, severe pulmonary disease (FEV1 < 50%), musculoskeletal disorders not allowing physical training on a cycle ergometer, or any other medical reasons by the physician considered to be a contraindication for moderate or high-intensity physical exercise
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Stefan De Smet, PhD contact
Belgium1 site, 1 recruiting
- Recruiting
UZ Leuven
Leuven, Vlaams-Brabant, 3000
Hanne Van Criekinge, +3216343162, hanne.vancriekinge@kuleuven.be
Diethard Monbaliu, MD PhD
About this study
Official title: A Home-based Exercise and Physical Activity Intervention After Liver Transplantation: Impact of Exercise Intensity - a Monocenter Randomized Controlled Trial [PHOENIX-Liver]
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.
Read the detailed description
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
- Liver Transplantation, Physical Fitness
- Being tested
- Physical activity, Sham intervention
- Keywords
- Exercise Intensity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activityOther
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.
Sham interventionOther
2 times a week, flexibility and balance training
| Study group | Role | What they receive |
|---|---|---|
| Sham Group | Sham comparator | Home-based low-intensity exercise training without subsequent physical activity intervention. Receives: Other: Sham intervention |
| Moderate-intensity (MIT) | Experimental | Home-based moderate-intensity exercise training with subsequent physical activity intervention. Receives: Other: Physical activity |
| Combined moderate and high-intensity (MHIT) | Experimental | Home-based moderate- and high-intensity exercise training with subsequent physical activity intervention. Receives: Other: Physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiorespiratory fitness
Changes in peak oxygen uptake (mL O2·min-1·kg-1) assessed by cardiopulmonary exercise test
Measured: 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
six-minute walking test (m)
Measured: At 0, 3 and 6 months of the interventional rehabilitation programme and 15 months after the end of the intervention
Hand grip strength
assessement by means of Jamar Hydraulic Hand Dynamometry (kg)
Measured: At 0, 3 and 6 months of the interventional rehabilitation programme and 15 months after the end of the intervention
Knee-extensor strength
assessement by means of Biodex dynamometer (Nm)
Measured: At 0, 3 and 6 months of the interventional rehabilitation programme and 15 months after the end of the intervention
Endothelial function
assessed via flow mediated dilation
Measured: At 0, 3 and 6 months of the interventional rehabilitation programme and 15 months after the end of the intervention
Arterial stiffness
assessed via pulse wave velocity
Measured: At 0, 3 and 6 months of the interventional rehabilitation programme and 15 months after the end of the intervention
Graft function
Transient elastography Fibroscan assessing liver stiffness
Measured: At 0 and after 21 months
Occurence of adverse events
Safety is estimated by means of questionnaires
Measured: Monthly
Motor fitness
Short Physical Performance Battery test
Measured: At 0, 3 and 6 months of the interventional rehabilitation programme and 15 months after the end of the intervention
Blood pressure
Variation in blood pressure measured by means of automatic device (Omron M6) in fasted condition and without medication taken in
Measured: At 0, 3 and 6 months of the interventional rehabilitation programme and 15 months after the end of the intervention
Blood profile
Blood is drawn when patient is in fasted condition and did not take their medication
Measured: At 0, 3 and 6 months of the interventional rehabilitation programme, and at 3 and 15 months after the end of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start1 Mar 2023
- Primary completionJan 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two interventional groups and one control group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 147 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06302205
- Sponsor's protocol ID
- S66232
- Acronym
- PHOENIX-L
- Status last verified
- Nov 2023
- First submitted
- 6 Dec 2023
- Last updated
- 1 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41214814De 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.
PubMed 40098918
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Home-based Exercise and Physical Activity Intervention After Liver Transplantation: Impact of Exercise Intensity - a Monocenter Randomized Controlled Trial [PHOENIX-Liver]
- ClinicalTrials.gov ID
- NCT06302205
- Acronym / sponsor ID
- PHOENIX-L / S66232
- Conditions
- Liver Transplantation, Physical Fitness
- Keywords
- Exercise Intensity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 147 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- KU Leuven
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 8 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Two interventional groups and one control group
| Arm | Type | Receives |
|---|---|---|
| Sham Group | Sham comparator | Other: Sham interventionHome-based low-intensity exercise training without subsequent physical activity intervention. |
| Moderate-intensity (MIT) | Experimental | Other: Physical activityHome-based moderate-intensity exercise training with subsequent physical activity intervention. |
| Combined moderate and high-intensity (MHIT) | Experimental | Other: Physical activityHome-based moderate- and high-intensity exercise training with subsequent physical activity intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- de novo adult liver transplant recipients with a transplant vintage of two to three months
- access to a home freezer (± -18°C)
Key exclusion criteria (6 listed)
- Aberrant CPET (abnormal low cardiorespiratory fitness is not considered an exclusion criteria), unstable angina, life-threatening arrhythmias, uncontrolled hypertension/diabetes, HbA1c ≥ 9%, severe pulmonary disease (FEV1 < 50%), musculoskeletal disorders not allowing physical training on a cycle ergometer, or any other medical reasons by the physician considered to be a contraindication for moderate or high-intensity physical exercise
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activityThe 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. | Other | Combined moderate and high-intensity (MHIT), Moderate-intensity (MIT) |
| Sham intervention2 times a week, flexibility and balance training | Other | Sham Group |
Primary outcome
Cardiorespiratory fitness
Time frame: At 0, 3 and 6 months of the interventional rehabilitation programme and at 15 months after the end of the intervention
Changes in peak oxygen uptake (mL O2·min-1·kg-1) assessed by cardiopulmonary exercise test
10 secondary outcomes
Functional exercise capacitiy
Time frame: At 0, 3 and 6 months of the interventional rehabilitation programme and 15 months after the end of the intervention
Hand grip strength
Time frame: At 0, 3 and 6 months of the interventional rehabilitation programme and 15 months after the end of the intervention
Knee-extensor strength
Time frame: At 0, 3 and 6 months of the interventional rehabilitation programme and 15 months after the end of the intervention
Endothelial function
Time frame: At 0, 3 and 6 months of the interventional rehabilitation programme and 15 months after the end of the intervention
Arterial stiffness
Time frame: At 0, 3 and 6 months of the interventional rehabilitation programme and 15 months after the end of the intervention
Graft function
Time frame: At 0 and after 21 months
Occurence of adverse events
Time frame: Monthly
Motor fitness
Time frame: At 0, 3 and 6 months of the interventional rehabilitation programme and 15 months after the end of the intervention
Blood pressure
Time frame: At 0, 3 and 6 months of the interventional rehabilitation programme and 15 months after the end of the intervention
Blood profile
Time frame: At 0, 3 and 6 months of the interventional rehabilitation programme, and at 3 and 15 months after the end of the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2024.
- Derived from this study: PubMed 41214814Leunis 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.
- Derived from this study: PubMed 40098918De 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stefan De Smet, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity in people with Liver Transplantation and Physical Fitness, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Diethard Monbaliu, MD PhD (+3216342361, diethard.monbaliu@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiorespiratory fitness (time frame: At 0, 3 and 6 months of the interventional rehabilitation programme and at 15 months after the end of the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06302205, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2024.