Instructed Home-based Physical Exercise for Patients With Liver Cirrhosis

Not Applicable

Recruiting

• Conditions: Liver Cirrhosis
• Interventions: Behavioral: Structured advice on physical activity; Behavioral: Standard of Care advice on physical activity

• Registration Number: NCT05061576
• Lead Sponsor: Karolinska University Hospital

Brief Summary

The study will compare two forms of advice regarding physical activity for patients hospitalized with cirrhosis that are preparing for leaving the hospital. One arm consists of current standard of care: simple oral advice on exercise. One arm instead gives patients a structured but simple paper template on physical activity.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-09
• Study First Submitted QC: 2021-09-18
• Study First Posted: 2021-09-29
• Study Start: 2022-08-16
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-02
• Last Update Posted: 2023-10-04
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Liver cirrhosis diagnosed with previous clinical assessment and radiology (de-formed liver, noduli, varices, collaterals, splenomegaly >12 cm) or with biopsy (fibrosis grade 4). ICD-code K70.3, K74.6.
• MELD < 25
• Understanding the Swedish language.
• Signed informed consent.

Exclusion Criteria

• Performance status ≥3.
• Severe pain which prevents the patient to perform the physical activities, as judged by the attending physician at time of discharge.
• Previously liver transplanted
• Unlikely to be compliant to follow-up (living in other parts of Sweden), as judged by the attending physician at time of discharge.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active intervention	Structured advice on physical activity	A leaflet with instructions and images on different forms of physical activities as well as clear recommendations on when to perform these.
Standard of care	Standard of Care advice on physical activity	Oral advice on exercise from a physician.

Primary Outcome Measures

Name	Time	Method
Change in quality of life summary score, as measured with the CLDQ tool	3 months	Change in quality of life, as measured with the CLDQ tool (gives a summary score between 1-7, a higher score suggests a better quality of life).

Secondary Outcome Measures

Name	Time	Method
Mortality	3 months	Overall mortality
MELD	3 months	Model of End-stage Liver Disease score (range 6-40, a higher score indicates a worse prognosis)
Frailty	3 months	Frailty as measured with the Liver Frailty Index.

Trial Locations

Locations (1)

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden