Preoperative Prehabilitation in Patients Planned for Liver Transplantation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorErasmus Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years,
Anticipated waitlisting for LT,
Speaks the Dutch language,
Understands the purpose of the study and has given written informed consent.
Disqualifiers
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,
Trial design
Design model
Single group
Treatments tested in this trial
Prehabilitation program
Other interventionParticipants 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.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Home based prehabilitationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Program satisfaction
Self-designed questionnaire score (score between 1-10, higher score means higher satisfaction)
Time frame
At completion of the prehabilitation program (8 weeks after baseline/screening for LT)2
Program compliance
Number of sessions that patient participates in the fitness training, the counselling on nutrition, smoking cessation and psychosocial sessions will be registered.
Time frame
At completion of the prehabilitation program (8 weeks after baseline/screening for LT)3
Percentage of patients willing to participate in the prehabilitation program
It will be registered which patients are willing and not willing to participate
Time frame
At the outpatient clinic, when patients make their appointment for screening for LTSecondary outcomes
1
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)
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.2
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.
Time frame
At baseline (before start prehabilitation program) and after eight weeks.3
Anthropometry
Body mass and body height will be measured with a calibrated electronic scale and e metric measuring tape with a wall stop.
Time frame
At baseline (before start prehabilitation program) and after eight weeks.4
Functional capacity
Patients are asked to walk as many meters as possible in a time period of 6 minutes.
Time frame
At baseline (before start prehabilitation program) and after eight weeks.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Erasmus Medical Center
Lead sponsor
Rijndam Revalidatiecentrum
Collaborator
Capri Hartrevalidatie
Collaborator
Source ClinicalTrials.gov