Home-based Bimodal Lifestyle Intervention in Patients With Liver Cirrhosis Awaiting Orthotopic Liver Transplantation

NCT05853484 | Not Yet Recruiting

• 1 other identifier: NL83612.042.23
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic liver disease eventually results in liver cirrhosis and is associated with an increasing deterioration in patients' physical fitness. As there is currently limited evidence regarding the effects of a home-based exercise program in patients with liver cirrhosis awaiting OLT, and physical frailty rates are particularly high in this patient population, this group has the investigators specific interest. The primary aim of this study is to assess the effect of a semi-supervised home-based bimodal lifestyle program, consisting of interval and endurance training and peripheral resistance training on aerobic capacity in patients with liver cirrhosis awaiting OLT

Conditions

Liver Cirrhosis; Liver Transplant; Complications; Physical Inactivity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Ultrasound measurements of muscle thickness

  through study completion, an average of 1 year

• Anthropometry assessment

  through study completion, an average of 1 year

• Functional mobility assessment

  through study completion, an average of 1 year

• Quality of Life assessment

  through study completion, an average of 1 year

• Perceived fatigue assessment

  through study completion, an average of 1 year

Study Arms (1)

Home based prehabilitation

EXPERIMENTAL

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

Other: Bimodal lifestyle program

Interventions

Bimodal lifestyle program OTHER

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

Home based prehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

Location

Related Publications (1)

• Wijma AG, Bongers BC, Annema C, Dekker R, Blokzijl H, van der Palen JA, De Meijer VE, Cuperus FJ, Klaase JM. 'Effects of a home-based bimodal lifestyle intervention in frail patients with end-stage liver disease awaiting orthotopic liver transplantation': study protocol of a non-randomised clinical trial. BMJ Open. 2024 Jan 29;14(1):e080430. doi: 10.1136/bmjopen-2023-080430.

  PMID: 38286689 DERIVED

MeSH Terms

Conditions

Liver Cirrhosis; Sedentary Behavior

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2023
• First Posted: May 10, 2023
• Study Start: September 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: August 1, 2025
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)