Instructed Home-based Physical Exercise for Patients With Liver Cirrhosis

Liver Cirrhosis Clinical Trial

— INSPEL  

Official title:

Instructed Home-based Physical Exercise for Patients With Liver Cirrhosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05061576
• Other study ID #: 2021-04454
• Status: Recruiting
• Phase: N/A
• Start date: August 16, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: October 2023
• Source: Karolinska University Hospital
• Contact: Hannes Hagström, MD PhD
• Phone: 0046858580000
• Email: hannes.hagstrom[@]ki.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fibrosis
• Liver Cirrhosis

Intervention

Behavioral:
• Standard of Care advice on physical activity
Oral advice on exercise from a physician.
• 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.

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska University Hospital	Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Frailty	Frailty as measured with the Liver Frailty Index.	3 months
Secondary	MELD	Model of End-stage Liver Disease score (range 6-40, a higher score indicates a worse prognosis)	3 months
Secondary	Mortality	Overall mortality	3 months