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Instructed Home-based Physical Exercise for Patients With Liver Cirrhosis

Instructed Home-based Physical Exercise for Patients With Liver Cirrhosis

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05061576
Acronym
INSPEL
Enrollment
100
Registered
2021-09-29
Start date
2022-08-16
Completion date
2026-12-31
Last updated
2023-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Cirrhosis

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.

Interventions

BEHAVIORALStandard of Care advice on physical activity

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.

Sponsors

Karolinska Institutet
CollaboratorOTHER
Karolinska University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in quality of life summary score, as measured with the CLDQ tool3 monthsChange 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

MeasureTime frameDescription
Frailty3 monthsFrailty as measured with the Liver Frailty Index.
MELD3 monthsModel of End-stage Liver Disease score (range 6-40, a higher score indicates a worse prognosis)
Mortality3 monthsOverall mortality

Countries

Sweden

Contacts

Primary ContactHannes Hagström, MD PhD
hannes.hagstrom@ki.se0046858580000
Backup ContactAndrea Lindfors, MD
andrea.lindfors@sll.se

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026