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Clinical Trials/NCT05061576
NCT05061576
Recruiting
Not Applicable

Instructed Home-based Physical Exercise for Patients With Liver Cirrhosis

Karolinska University Hospital1 site in 1 country100 target enrollmentAugust 16, 2022
ConditionsLiver Cirrhosis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Liver Cirrhosis
Sponsor
Karolinska University Hospital
Enrollment
100
Locations
1
Primary Endpoint
Change in quality of life summary score, as measured with the CLDQ tool
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 16, 2022
End Date
December 31, 2026
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Karolinska University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Hannes Hagström

Principal Investigator

Karolinska University Hospital

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.
  • MELD \< 25
  • Understanding the Swedish language.
  • Signed informed consent.

Exclusion Criteria

  • Performance status ≥
  • 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.

Outcomes

Primary Outcomes

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

  • Mortality(3 months)
  • MELD(3 months)
  • Frailty(3 months)

Study Sites (1)

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