- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05853484
Home-based Bimodal Lifestyle Intervention in Patients With Liver Cirrhosis Awaiting Orthotopic Liver Transplantation (FIT4Cirrhotics)
FIT4Cirrhotics@Home: Effects of a Home-based Bimodal Lifestyle Intervention in Patients With Liver Cirrhosis Awaiting Orthotopic Liver Transplantation
Study Overview
Status
Intervention / Treatment
Detailed Description
Rationale: Patients with liver cirrhosis who are on the waiting list for orthotopic liver transplantation (OLT) encounter all key components of physical frailty, i.e., decreased functional capacity, impaired aerobic capacity and sarcopenia, which all lead to fatigue, diminished quality of life, increased hospitalization and pre- and post-transplantation morbidity and mortality. An exercise program in combination with nutritional support has proven to improve all key components of physical frailty and quality of life in various surgical patient populations. Although small studies have demonstrated similar positive effects of exercise training in patients on the waiting list for OLT, to date no large studies supported the effects of exercise training and nutritional support on (the longevity of) the increase in aerobic capacity in OLT patients.
Objective: The primary objective of this study is to assess the effect of a semi-supervised home based bimodal lifestyle intervention on aerobic capacity (measured by VO2 at the Ventilatory anaerobic threshold (VAT) and VO2peak in ml/kg/min) in patients with liver cirrhosis on the waiting list for OLT. Secondary objectives are to evaluate individual patients' responses to the bimodal lifestyle intervention on sarcopenia, anthropometry, functional mobility, quality of life, perceived fatigue, incidence of hepatic encephalopathy, number of unplanned hospital admissions, change in liver frailty index score and change in microbiome composition at six, 12 and 18 weeks, or until transplantation. Finally, the feasibility (participation rate, reasons for non-participation, adherence/compliance, dropout rate, reasons for dropout and adverse event) will be assessed.
Study design: This study is an investigator-initiated, single center, single arm, prospective clinical trial. It will take place at the University Medical Center Groningen, the Netherlands. Eligible patients will participate in the bimodal lifestyle program, which comprises two home-based training periods of six-weeks each (12 weeks training in total, or until transplantation). After 18 weeks (i.e., six weeks after termination of the program) a final assessment will take place to evaluate the longevity of the expected effects of the lifestyle program on predefined study outcomes.
Study population: Adult patients diagnosed with liver cirrhosis and screened for OLT, with a VO2 at the VAT ≤13ml/kg/min and/or VO2peak ≤18ml/kg/min will be screened for potential eligibility. Patients with no contraindications to physical exercise training and the ability to work out on a cycle ergometer can participate in the bimodal lifestyle intervention.
Intervention: Patients will participate in a home-based bimodal lifestyle program. The program comprises semi-supervised high intensity interval and endurance training on an advanced cycle ergometer (Lode Corival Home+ , Lode BV, Groningen, The Netherlands), combined with nutritional support consisting of protein, vitamin and mineral supplementation. Moreover, to improve functional mobility and muscle function patients will perform peripheral resistance training of the large muscle groups of the upper and lower extremities. Finally, to improve respiratory performance after surgery and potentially reduce pulmonary complications, patients will perform breathing exercises. The program will be patient personalized and compromises three training sessions per week. The cycle ergometer used for this program will upload training results of the interval and endurance training sessions to an online platform, enabling remote monitoring of patients' adherence and training progress. Furthermore, a community physical therapist will visit the patient at least weekly to monitor progress and to optimize the training intensity.
Main study parameters/endpoints: The main study parameter/endpoint is the progression in aerobic capacity after 6 weeks. Hereto, before and after the first training period a CPET will performed to determine the difference in VO2 at the VAT and VO2peak in ml/kg/min. A secondary parameter/endpoint of this study is the progression in aerobic capacity after the second training period, and six weeks after termination of the program. Hereto, after 12 and 18 weeks another CPET will be performed. Other secondary parameters/endpoints are the evaluation of differences in sarcopenia, anthropometry, functional mobility, quality of life, perceived fatigue, incidence of hepatic encephalopathy, number of unplanned hospital admissions, change in liver frailty index score and change in microbiome composition at six, 12 and 18 weeks, or until transplantation. Furthermore, postoperative outcomes up to twelve months post-OLT will be collected.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Because the exercise program is situated at home (both the cycle ergometer as the community physiotherapist will come to the patient) the investigators make things as accessible as possible for the patient to participate. Supervision by the physiotherapist during the training sessions is arranged three times in the first week and at least once a week thereafter. At the start of the program a CPET with continuous ECG monitoring will be executed under guidance of trained employees to assess baseline cardiorespiratory fitness, as well as to rule out strain related cardiac ischemia and other contraindications for physical exercise training during the consecutive exercise program. Hence, patient's safety in the exercise program is guaranteed. To minimize the burden of this study, the majority of the visits, withdrawal of blood samples, physical examinations and other study procedures, are combined with regular outpatient clinic visits.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Groningen, Netherlands, 9713 GZ
- University Medical Center Groningen
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged at least 18 years;
- Diagnosed with end-stage liver disease / liver cirrhosis (regardless of etiology);
- On the waiting list for OLT;
- VO2 at the VAT ≤13 ml/kg/min and/or VO2peak ≤18 ml/kg/min;
- Speaks the Dutch language;
- Understands the purpose of the study and has given written informed consent to participate in the study.
Exclusion Criteria:
- Experienced a MACE (e.g., myocardial infarction) 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., variceal eradication endoscopy and/or adequately dosed NSBB);
- MELD score ≥30;
- Not capable of cycling on a cycle ergometer;
- No available community physical therapist in the living area of the patient.
- Patients refusing or unable to sign informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Home based prehabilitation
Participants will be subjected to two training periods of six weeks (or until transplantation) of a semi-supervised home-based bimodal lifestyle program.
The bimodal lifestyle program consists of an exercise program combined with nutritional support.
The exercise program comprises high intensity interval training and endurance training, combined with peripheral resistance training and breathing exercises
|
Participants will be subjected to two training periods of six weeks (or until transplantation) of a semi-supervised home-based bimodal lifestyle program.
The bimodal lifestyle program consists of an exercise program combined with nutritional support.
The exercise program comprises high intensity interval training and endurance training, combined with peripheral resistance training and breathing exercises
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Aerobic capacity
Time Frame: During baseline measurements patients will perform a cardiopulmonary exercise test to determine their baseline aerobic capacity. After 6 weeks of home-based training the cardiopulmonary exercise test will be repeated to reassess their aerobic capacity.
|
The main study parameter/endpoint is the change in aerobic capacity after the first six weeks of the FIT4Cirrhotics@Home program, for which the following outcomes will be assessed: VO2 at the VAT (ml/kg/min).
A cardiopulmonary exercise test will be performed by participants to determine their aerobic capacity pre-intervention and after six weeks of training.
|
During baseline measurements patients will perform a cardiopulmonary exercise test to determine their baseline aerobic capacity. After 6 weeks of home-based training the cardiopulmonary exercise test will be repeated to reassess their aerobic capacity.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ultrasound measurements of muscle thickness
Time Frame: through study completion, an average of 1 year
|
Sarcopenia in patients will be assessed by measuring muscle thickness with point-of-care ultrasound before and after the bimodal lifestyle program.
|
through study completion, an average of 1 year
|
Anthropometry assessment
Time Frame: through study completion, an average of 1 year
|
Body mass and height used to calculate the body mass index
|
through study completion, an average of 1 year
|
Functional mobility assessment
Time Frame: through study completion, an average of 1 year
|
30-sec chair-stand test will be performed to assess functional mobility
|
through study completion, an average of 1 year
|
Quality of Life assessment
Time Frame: through study completion, an average of 1 year
|
Questionnaire
|
through study completion, an average of 1 year
|
Perceived fatigue assessment
Time Frame: through study completion, an average of 1 year
|
Questionnaire
|
through study completion, an average of 1 year
|
Incidence of hepatic encephalopathy assessment
Time Frame: through study completion, an average of 1 year
|
Determined using the animal naming test
|
through study completion, an average of 1 year
|
Number and reasons for intercurrent hospitalizations assessment
Time Frame: through study completion, an average of 1 year
|
Number and reasons for intercurrent hospitalizations, with more hospitalizations representing poorer patient outcomes.
Minimum hospitalization 0, maximum not predefined.
|
through study completion, an average of 1 year
|
Liver frailty index score assessment
Time Frame: During through study completion, an average of 1 year and immediately post-intervention
|
Determined using https://liverfrailtyindex.ucsf.edu.
Scale ranges from 0 - 7 points.
A higher score represents a higher risk of clinical frailty.
|
During through study completion, an average of 1 year and immediately post-intervention
|
Microbiome composition assessment
Time Frame: through study completion, an average of 1 year
|
By analyzing feces collections
|
through study completion, an average of 1 year
|
Postoperative outcomes up to 12 months post-OLT assessment
Time Frame: through study completion, and up to 12 months post-OLT assessment
|
All surgical relevant postoperative outcomes up to 12 months post-OLT are recorded.
Of which, ICU admittance, length of hospital stay, unplanned readmissions, and one-year patient- and graft survival.
All displayed as absolute and relative frequencies.
|
through study completion, and up to 12 months post-OLT assessment
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NL83612.042.23
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Liver Cirrhosis
-
Postgraduate Institute of Medical Education and...Society for the Study of Liver Diseases, Chandigarh ( India )UnknownDecompensated Cirrhosis of LiverIndia
-
SUUMC Central Military Hospital Dr Carol DavilaRecruiting
-
The Cleveland ClinicRecruiting
-
The Cleveland ClinicRecruitingCirrhosis, LiverUnited States
-
University of PittsburghNational Institute on Drug Abuse (NIDA)CompletedCirrhosis, LiverUnited States
-
Beth Israel Deaconess Medical CenterAmerican Association for the Study of Liver Diseases FoundationCompleted
-
Asian Institute of Gastroenterology, IndiaCompletedCirrhosis, LiverIndia
-
Sherief Abd-ElsalamUnknown
-
Fundació Institut de Recerca de l'Hospital de la...Spanish Clinical Research Network - SCReNWithdrawn
Clinical Trials on Bimodal lifestyle program
-
Azienda Ospedaliero-Universitaria CareggiRecruitingDiabetes Mellitus, Type 2Italy
-
Scripps Center for Integrative MedicineUnknown
-
Medical College of WisconsinLoyola University ChicagoCompletedBreast Cancer | Gynecologic CancerUnited States
-
Boston Heart DiagnosticsHeart Fit for Duty, LLCCompleted
-
Sheba Medical CenterD-Cure, Israel; Rashi FoundationCompleted
-
Universitair Ziekenhuis BrusselTerminatedPolycystic Ovarian Syndrome | Infertility, Female | LifestyleBelgium
-
Federal University of Juiz de ForaCoordenação de Aperfeiçoamento de Pessoal de Nível Superior.; Federal University... and other collaboratorsRecruitingDiabetes Mellitus | PrediabetesBrazil
-
National Heart, Lung, and Blood Institute (NHLBI)CompletedLung Diseases, Obstructive | Pulmonary Disease, Chronic ObstructiveUnited States
-
University of the Basque Country (UPV/EHU)Universidad Pública de Navarra; Ministerio de Economía y Competitividad, SpainCompletedOverweight Children With Type 2 Diabetes RiskSpain
-
Heidelberg UniversityRecruiting