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NCT Number: NCT05061576

Instructed Home-based Physical Exercise for Patients With Liver Cirrhosis

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska University Hospital

Stockholm, 14186, Sweden

Location status: Recruiting

Location contact

Hannes Hagström, MD, PhD

CONTACT

[email protected]

0046858580000

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standard of Care advice on physical activity

Behavioral

Oral advice on exercise from a physician.

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.

Primary outcomes

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

    Time frame: 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 outcomes

  1. Frailty

    Time frame: 3 months

    Frailty as measured with the Liver Frailty Index.

  2. MELD

    Time frame: 3 months

    Model of End-stage Liver Disease score (range 6-40, a higher score indicates a worse prognosis)

  3. Mortality

    Time frame: 3 months

    Overall mortality

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea Lindfors, MD

CONTACT

[email protected]

Hannes Hagström, MD PhD

CONTACT

[email protected]

0046858580000

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Collaborators

  • Karolinska Institutet

Registry information

Acronym: INSPEL

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Sep 29, 2021
Registry last updated
Oct 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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