Instructed Home-based Physical Exercise for Patients With Liver Cirrhosis

Study Overview
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Brief Summary
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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.

Official Title
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Instructed Home-based Physical Exercise for Patients With Liver Cirrhosis

Conditions
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Liver Cirrhosis

Intervention / Treatment
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* Behavioral: Standard of Care advice on physical activity
* Behavioral: Structured advice on physical activity


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of care<br>Oral advice on exercise from a physician. | Behavioral: Standard of Care advice on physical activity<br>* Oral advice on exercise from a physician.<br>|
| Experimental: Active intervention<br>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<br>* A leaflet with instructions and images on different forms of physical activities as well as clear recommendations on when to perform these.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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