Back to resultsInstructed Home-based Physical Exercise for Patients With Liver Cirrhosis (INSPEL)
Primary Purpose
Liver Cirrhosis
Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Standard of Care advice on physical activity
Structured advice on physical activity
Sponsored by
About this trial
This is an interventional supportive care trial for Liver Cirrhosis
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.
Sites / Locations
- Karolinska University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard of care
Active intervention
Arm Description
Oral advice on exercise from a physician.
A leaflet with instructions and images on different forms of physical activities as well as clear recommendations on when to perform these.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Frailty
Frailty as measured with the Liver Frailty Index.
MELD
Model of End-stage Liver Disease score (range 6-40, a higher score indicates a worse prognosis)
Mortality
Overall mortality
Full Information
NCT ID
NCT05061576
First Posted
September 9, 2021
Last Updated
October 2, 2023
Sponsor
Karolinska University Hospital
Collaborators
Karolinska Institutet
1. Study Identification
Unique Protocol Identification Number
NCT05061576
Brief Title
Instructed Home-based Physical Exercise for Patients With Liver Cirrhosis
Acronym
INSPEL
Official Title
Instructed Home-based Physical Exercise for Patients With Liver Cirrhosis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 16, 2022 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska University Hospital
Collaborators
Karolinska Institutet
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard of care
Arm Type
Active Comparator
Arm Description
Oral advice on exercise from a physician.
Arm Title
Active intervention
Arm Type
Experimental
Arm Description
A leaflet with instructions and images on different forms of physical activities as well as clear recommendations on when to perform these.
Intervention Type
Behavioral
Intervention Name(s)
Standard of Care advice on physical activity
Intervention Description
Oral advice on exercise from a physician.
Intervention Type
Behavioral
Intervention Name(s)
Structured advice on physical activity
Intervention Description
A leaflet with instructions and images on different forms of physical activities as well as clear recommendations on when to perform these.
Primary Outcome Measure Information:
Title
Change in quality of life summary score, as measured with the CLDQ tool
Description
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).
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Frailty
Description
Frailty as measured with the Liver Frailty Index.
Time Frame
3 months
Title
MELD
Description
Model of End-stage Liver Disease score (range 6-40, a higher score indicates a worse prognosis)
Time Frame
3 months
Title
Mortality
Description
Overall mortality
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hannes Hagström, MD PhD
Phone
0046858580000
Email
hannes.hagstrom@ki.se
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea Lindfors, MD
Email
andrea.lindfors@sll.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hannes Hagström, MD PhD
Organizational Affiliation
Karolinska University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska University Hospital
City
Stockholm
ZIP/Postal Code
14186
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hannes Hagström, MD, PhD
Phone
0046858580000
Email
hannes.hagstrom@ki.se
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Instructed Home-based Physical Exercise for Patients With Liver Cirrhosis
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