Instructed Home-based Physical Exercise for Patients With Liver Cirrhosis (INSPEL)

Karolinska University Hospital

Status: Enrolling

Conditions: Liver Cirrhosis

Treatments: Behavioral: Structured advice on physical activity; Behavioral: Standard of Care advice on physical activity

Study type: Interventional

Funder types: Other

Identifiers

NCT05061576

2021-04454

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Standard of care

Active Comparator group

Description:

Oral advice on exercise from a physician.

Treatment:

Behavioral: Standard of Care advice on physical activity

Active intervention

Experimental group

Description:

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

Treatment:

Behavioral: Structured advice on physical activity