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FIT4Cirrhotics@Home: Effects of a home-based, bimodal lifestyle intervention in patients with liver cirrhosis awaiting orthotopic liver transplantation.

FIT4Cirrhotics@Home: Effects of a home-based, bimodal lifestyle intervention in patients with liver cirrhosis awaiting orthotopic liver transplantation. - FIT4Cirrhotics@Home

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON53348
Enrollment
16
Registered
2023-08-02
Start date
2024-10-22
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver cirrhosis liver scarring

Interventions

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

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Diagnosed with end-stage liver disease / liver cirrhosis (regardless of etiology); • On the waiting list for OLT; • VO2 at the VAT

Exclusion criteria

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); • 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

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)