Instructed Home-based Physical Exercise for Patients With Liver Cirrhosis

NCT05061576 | Recruiting

• 1 other identifier: 2021-04454
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Change in quality of life summary score, as measured with the CLDQ tool

  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).

  3 months

Secondary Outcomes (3)

• Frailty

  3 months

• MELD

  3 months

• Mortality

  3 months

Study Arms (2)

Standard of care

ACTIVE COMPARATOR

Oral advice on exercise from a physician.

Behavioral: Standard of Care advice on physical activity

Active intervention

EXPERIMENTAL

A leaflet with instructions and images on different forms of physical activities as well as clear recommendations on when to perform these.

Behavioral: Structured advice on physical activity

Interventions

Standard of Care advice on physical activity BEHAVIORAL

Oral advice on exercise from a physician.

Standard of care

Structured advice on physical activity BEHAVIORAL

A leaflet with instructions and images on different forms of physical activities as well as clear recommendations on when to perform these.

Active intervention

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska University Hospital: lead
• Karolinska Institutet: collaborator

Study Sites (1)

Karolinska University Hospital

Stockholm, 14186, Sweden

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Hannes Hagström, MD PhD

  Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hannes Hagström, MD PhD

CONTACT

0046858580000; hannes.hagstrom@ki.se

Andrea Lindfors, MD

CONTACT

andrea.lindfors@sll.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: September 29, 2021
• Study Start: August 16, 2022
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 4, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)