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

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.

Study Overview

• Status: Recruiting
• Conditions: Liver Cirrhosis
• Intervention / Treatment: Behavioral: Standard of Care advice on physical activity; Behavioral: Structured advice on physical activity

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hannes Hagström, MD PhD; Phone Number: 0046858580000; Email: hannes.hagstrom@ki.se
• Study Contact Backup: Name: Andrea Lindfors, MD; Email: andrea.lindfors@sll.se

Study Locations

• Sweden
  • Stockholm, Sweden, 14186
    • Recruiting
    • Karolinska University Hospital
    • Contact: Hannes Hagström, MD, PhD; Phone Number: 0046858580000; Email: hannes.hagstrom@ki.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Karolinska University Hospital
• Collaborators: Karolinska Institutet
• Investigators: Principal Investigator: Hannes Hagström, MD PhD, Karolinska University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2022
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: September 9, 2021
• First Submitted That Met QC Criteria: September 18, 2021
• First Posted (Actual): September 29, 2021

Study Record Updates

• Last Update Posted (Actual): October 4, 2023
• Last Update Submitted That Met QC Criteria: October 2, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis
• Other Study ID Numbers: 2021-04454

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No