Recruiting NCT05061576
Instructed Home-based Physical Exercise for Patients With Liver Cirrhosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standard of Care advice on physical activity, Structured advice on physical activity.
- Who it may be relevant to
- Registry conditions: Liver Cirrhosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Behavioral Standard of Care advice on physical activity
Oral advice on exercise from a physician. - Behavioral 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.
Primary outcome measures
- Change in quality of life summary score, as measured with the CLDQ tool [Time frame: 3 months]
Secondary outcome measures (3)
- Frailty [Time frame: 3 months]
- MELD [Time frame: 3 months]
- Mortality [Time frame: 3 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Sweden · 1 center
- Karolinska University Hospital — Stockholm
Identifiers
NCT: NCT05061576 · 2021-04454