Liver Transplant; ComplicationsPRELIVERTNCT06808945
Preoperative Prehabilitation in Patients Planned for Liver Transplantation
A study testing Prehabilitation program in people with Liver Transplant; Complications and Physical Inactivity, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
The objective of this study is to determine the feasibility and effectiveness of a home-based multimodal prehabilitation program in patients anticipated to be waitlisted for LT. Patients will participate in an eight week prehabilitation program consisting of physical exercise, nutritional support, smoking cessation… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplant; Complications, Physical Inactivity
- What is being tested?
- Prehabilitation program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteNetherlands
- Study dates
- 2 Oct 2024to Jul 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
- Age ≥18 years,
- Anticipated waitlisting for LT,
- Speaks the Dutch language,
- Understands the purpose of the study and has given written informed consent.
Who cannot join
- Experienced a major adverse cardiovascular event in the past six months,
- Experienced a cerebrovascular incident in the past six months,
- Medical history of an uncontrolled heart rhythm disorder,
- Hepatic encephalopathy grade 3 or 4,
- Acute liver failure,
- Acute-on-chronic liver failure,
- Hospitalization at start of the study.
- Non-treated esophageal varices (i.e., no previous variceal eradication endoscopy or adequately dosed NSBB)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus Medical Center
Rotterdam, 3015 CN
Lysanne P.M. Beuk, +31615822753, l.p.m.beuk@erasmusmc.nl
About this study
Official title: Preoperative PREhabilitation in Patients Planned for LIVER Transplantation (PRELIVERT)
The objective of this study is to determine the feasibility and effectiveness of a home-based multimodal prehabilitation program in patients anticipated to be waitlisted for LT. Patients will participate in an eight week prehabilitation program consisting of physical exercise, nutritional support, smoking cessation and psychological counselling.
Read the detailed description
Rationale: Patients who qualify for liver transplantation (LT) are mostly frail due to their underlying liver disease. Frailty is comprised by a decreased functional capacity, impaired aerobic capacity, and sarcopenia. It is well known that frailty leads to both increased pre- and post-transplantation morbidity as well as mortality. For various surgical populations prehabilitation was demonstrated to be feasible, effective, and to improve surgical outcomes. Few studies on this subject have been conducted in the patient population awaiting liver transplantation.
Objective: The primary objective is to determine the feasibility of a semi-supervised homebased prehabilitation program for patients to be waitlisted for LT. The secondary objectives are to assess the effectiveness of this program and possible improvements of surgical outcomes (e.g. less complications, faster recovery, and shorter length of hospital stay).
Study design: This is a multi-centre, single arm, prospective cohort (pilot) study. It will take place at the Erasmus Medical Center in Rotterdam, the Netherlands.
Study population: Adult patients who are anticipated to be waitlisted for LT, who have no contra-indications to physical exercise training.
Intervention: Patients will participate in an eight-week semi-supervised home based prehabilitation program. This program consists of physical exercise, nutritional support provided by a dietician, smoking cessation, and psychological counselling. The program will be personalized and consists of two training sessions per week. Through the Oefenportaal platform the physical therapist will supervise the exercises and monitor patients' adherence to the program.
Main study parameters/endpoints: The main study parameter/endpoint is the feasibility of the prehabilitation program (program satisfaction, compliance, and percentage of patients willing to participate in the prehabilitation program). A secondary outcome is the effectiveness of the program. Furthermore, postoperative outcomes after 30 days will be collected.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients will participate in an eight-week prehabilitation program prior to anticipated LT. The prehabilitation sessions take approximately 3-5 hours per week. To lower the burden for patients, the majority of the program takes place at home using digital tools. During the first week patients are seen at the Erasmus MC for an intake (about 60 minutes). All study appointments will be combined with regular appointments for screening if possible. Furthermore, patients are expected on-site at the start and after completion of the prehabilitation program to undergo measurements (90 minutes). Also, they have to complete questionnaires at home three times total (two times 20 minutes, one time 10 minutes).
Since the prehabilitation program is based on existing care, we expect minimal risks for the patients. Participants are anticipated to benefit from the pilot prehabilitation program considering a better physical fitness and a behavioural change towards a healthier lifestyle.
- Being tested
- Prehabilitation program
- Keywords
- prehabilitation, liver transplant
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prehabilitation programOther
Participants will be subjected to an eight week home-based multimodal prehabilitaiton program. The program consists of an exercise program, nutritional support, smoking cessation and psychological counselling.
| Study group | Role | What they receive |
|---|---|---|
| Home based prehabilitation | Experimental | Participants will be subjected to a training period of eight weeks of a home-based multimodal prehabilitation program. The program consists of an exercise program, nutritional support, smoking cessation and psychological counselling. Receives: Other: Prehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Program satisfaction
Self-designed questionnaire score (score between 1-10, higher score means higher satisfaction)
Measured: At completion of the prehabilitation program (8 weeks after baseline/screening for LT)
Program compliance
Number of sessions that patient participates in the fitness training, the counselling on nutrition, smoking cessation and psychosocial sessions will be registered.
Measured: At completion of the prehabilitation program (8 weeks after baseline/screening for LT)
Percentage of patients willing to participate in the prehabilitation program
It will be registered which patients are willing and not willing to participate
Measured: At the outpatient clinic, when patients make their appointment for screening for LT
Secondary outcomes (11)
Aerobic capacity
A cardiopulmonary exercise test (CPET) will be performed by participants to determine their aerobic capacity pre-intervention and at the end of the program. The following outcomes will be assessed: VO2 at the VAT (ml/kg/min)
Measured: At start of the program, when patients are admitted for screening, they will perform a CPET as baseline. After eight weeks of home-based training the CPET will be reassessed.
Sarcopenia
Body composition will be determined by bioelectrical impedance analysis at baseline and after eight weeks. Also patients will be asked to fill out a sarcopenia specific questionnaire: the SARC-F.
Measured: At baseline (before start prehabilitation program) and after eight weeks.
Anthropometry
Body mass and body height will be measured with a calibrated electronic scale and e metric measuring tape with a wall stop.
Measured: At baseline (before start prehabilitation program) and after eight weeks.
Functional capacity
Patients are asked to walk as many meters as possible in a time period of 6 minutes.
Measured: At baseline (before start prehabilitation program) and after eight weeks.
Functional mobility
Functional mobility will be assessed using the 30-second chair stand test.
Measured: At baseline (before start prehabilitation program) and after eight weeks.
Physical activity level
ActiGraph GTx3+ accelerometer: average time per day (min) spend in moderate-to-vigorous activity, light physical activity and sedentary behaviour Futhermore patients will be asked to monitor the amount of steps taken per day using the 'Oefenportaal platform'
Measured: At baseline (before start prehabilitation program) and after eight weeks patients will wear the ActiGraph accelerometer for 7 days.
Hand grip strength
Hand dynamometer (kg)
Measured: At baseline (before start prehabilitation program) and after eight weeks.
Quadriceps strength
Biodex dynamometer (Peak torque to body weight extension + Work fatigue)
Measured: At baseline (before start prehabilitation program) and after eight weeks
Quality of life assessment
Questionnaire
Measured: At baseline (before start prehabilitation program) and after eight weeks
Perceived fatigue assessment
Questionnaire
Measured: At baseline (before start prehabilitation program) and after eight weeks
Postoperative outcomes up to 30 days post LT assessment
All surgical relevant postoperative outcomes up to 12 months post LT are recorded.
Measured: Through study completion (30 days after LT)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start2 Oct 2024
- Primary completionApr 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Transplant; ComplicationsStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Rijndam Revalidatiecentrum, Capri Hartrevalidatie
- Responsible party
- Principal investigator, Roeland F. de Wilde, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06808945
- Sponsor's protocol ID
- NL85306.078.23
- Acronym
- PRELIVERT
- Status last verified
- Feb 2025
- First submitted
- 25 Nov 2024
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative PREhabilitation in Patients Planned for LIVER Transplantation (PRELIVERT)
- ClinicalTrials.gov ID
- NCT06808945
- Acronym / sponsor ID
- PRELIVERT / NL85306.078.23
- Keywords
- prehabilitation, liver transplant
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Rijndam Revalidatiecentrum, Capri Hartrevalidatie
- Study start
- 2 Oct 2024 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 5 Feb 2025 (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.
The objective of this study is to determine the feasibility and effectiveness of a home-based multimodal prehabilitation program in patients anticipated to be waitlisted for LT. Patients will participate in an eight week prehabilitation program consisting of physical exercise, nutritional support, smoking cessation and psychological counselling.
Detailed description
Rationale: Patients who qualify for liver transplantation (LT) are mostly frail due to their underlying liver disease. Frailty is comprised by a decreased functional capacity, impaired aerobic capacity, and sarcopenia. It is well known that frailty leads to both increased pre- and post-transplantation morbidity as well as mortality. For various surgical populations prehabilitation was demonstrated to be feasible, effective, and to improve surgical outcomes. Few studies on this subject have been conducted in the patient population awaiting liver transplantation.
Objective: The primary objective is to determine the feasibility of a semi-supervised homebased prehabilitation program for patients to be waitlisted for LT. The secondary objectives are to assess the effectiveness of this program and possible improvements of surgical outcomes (e.g. less complications, faster recovery, and shorter length of hospital stay).
Study design: This is a multi-centre, single arm, prospective cohort (pilot) study. It will take place at the Erasmus Medical Center in Rotterdam, the Netherlands.
Study population: Adult patients who are anticipated to be waitlisted for LT, who have no contra-indications to physical exercise training.
Intervention: Patients will participate in an eight-week semi-supervised home based prehabilitation program. This program consists of physical exercise, nutritional support provided by a dietician, smoking cessation, and psychological counselling. The program will be personalized and consists of two training sessions per week. Through the Oefenportaal platform the physical therapist will supervise the exercises and monitor patients' adherence to the program.
Main study parameters/endpoints: The main study parameter/endpoint is the feasibility of the prehabilitation program (program satisfaction, compliance, and percentage of patients willing to participate in the prehabilitation program). A secondary outcome is the effectiveness of the program. Furthermore, postoperative outcomes after 30 days will be collected.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients will participate in an eight-week prehabilitation program prior to anticipated LT. The prehabilitation sessions take approximately 3-5 hours per week. To lower the burden for patients, the majority of the program takes place at home using digital tools. During the first week patients are seen at the Erasmus MC for an intake (about 60 minutes). All study appointments will be combined with regular appointments for screening if possible. Furthermore, patients are expected on-site at the start and after completion of the prehabilitation program to undergo measurements (90 minutes). Also, they have to complete questionnaires at home three times total (two times 20 minutes, one time 10 minutes).
Since the prehabilitation program is based on existing care, we expect minimal risks for the patients. Participants are anticipated to benefit from the pilot prehabilitation program considering a better physical fitness and a behavioural change towards a healthier lifestyle.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Home based prehabilitation | Experimental | Other: Prehabilitation programParticipants will be subjected to a training period of eight weeks of a home-based multimodal prehabilitation program. The program consists of an exercise program, nutritional support, smoking cessation and psychological counselling. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years,
- Anticipated waitlisting for LT,
- Speaks the Dutch language,
- Understands the purpose of the study and has given written informed consent.
Key exclusion criteria (8 listed)
- Experienced a major adverse cardiovascular event in the past six months,
- Experienced a cerebrovascular incident in the past six months,
- Medical history of an uncontrolled heart rhythm disorder,
- Hepatic encephalopathy grade 3 or 4,
- Acute liver failure,
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 |
|---|---|---|
| Prehabilitation programParticipants will be subjected to an eight week home-based multimodal prehabilitaiton program. The program consists of an exercise program, nutritional support, smoking cessation and psychological counselling. | Other | Home based prehabilitation |
Primary outcome
Program satisfaction
Time frame: At completion of the prehabilitation program (8 weeks after baseline/screening for LT)
Self-designed questionnaire score (score between 1-10, higher score means higher satisfaction)
Program compliance
Time frame: At completion of the prehabilitation program (8 weeks after baseline/screening for LT)
Number of sessions that patient participates in the fitness training, the counselling on nutrition, smoking cessation and psychosocial sessions will be registered.
Percentage of patients willing to participate in the prehabilitation program
Time frame: At the outpatient clinic, when patients make their appointment for screening for LT
It will be registered which patients are willing and not willing to participate
11 secondary outcomes
Aerobic capacity
Time frame: At start of the program, when patients are admitted for screening, they will perform a CPET as baseline. After eight weeks of home-based training the CPET will be reassessed.
Sarcopenia
Time frame: At baseline (before start prehabilitation program) and after eight weeks.
Anthropometry
Time frame: At baseline (before start prehabilitation program) and after eight weeks.
Functional capacity
Time frame: At baseline (before start prehabilitation program) and after eight weeks.
Functional mobility
Time frame: At baseline (before start prehabilitation program) and after eight weeks.
Physical activity level
Time frame: At baseline (before start prehabilitation program) and after eight weeks patients will wear the ActiGraph accelerometer for 7 days.
Hand grip strength
Time frame: At baseline (before start prehabilitation program) and after eight weeks.
Quadriceps strength
Time frame: At baseline (before start prehabilitation program) and after eight weeks
Quality of life assessment
Time frame: At baseline (before start prehabilitation program) and after eight weeks
Perceived fatigue assessment
Time frame: At baseline (before start prehabilitation program) and after eight weeks
Postoperative outcomes up to 30 days post LT assessment
Time frame: Through study completion (30 days after LT)
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 5 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Liver Transplant; Complications
Not yet recruiting
New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.
Liver Transplantation (LT), Early Allograft Dysfunction
Active, not recruitingPhase 2
MT2013-31: Allo HCT for Metabolic Disorders and Severe Osteopetrosis
Mucopolysaccharidosis Disorders, Hurler Syndrome
Recruiting
Avoiding Recooling After Normothermic Machine Perfusion in Liver Transplantation
Liver Transplantation (LT), Ischemia-Reperfusion Injury
Not yet recruitingObservational study
Prospective Observational Multimodal Neuromonitoring During High-Risk Adult Surgery
Postoperative Cognitive Complications, Delirium
Not yet recruiting
Prophylactic Norepinephrine for Prevention of Acute Kidney Injury in Living-Donor Liver Transplantation
Noradrenaline
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prehabilitation program in people with Liver Transplant; Complications and Physical Inactivity, run by Erasmus Medical Center at 1 site in Netherlands.
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 4 inclusion and 8 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 5 Feb 2025. 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 Netherlands. 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. 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 Lysanne P.M. Beuk (+31615822753, l.p.m.beuk@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Program satisfaction (time frame: At completion of the prehabilitation program (8 weeks after baseline/screening for LT)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Feb 2025.