Instructed Home-based Physical Exercise for Patients With Liver Cirrhosis

NCT ID: NCT05061576

Last Updated: 2023-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-16

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Liver Cirrhosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Standard of care

Oral advice on exercise from a physician.

Group Type ACTIVE_COMPARATOR

Standard of Care advice on physical activity

Intervention Type BEHAVIORAL

Oral advice on exercise from a physician.

Active intervention

A leaflet with instructions and images on different forms of physical activities as well as clear recommendations on when to perform these.

Group Type EXPERIMENTAL

Structured advice on physical activity

Intervention Type BEHAVIORAL

A leaflet with instructions and images on different forms of physical activities as well as clear recommendations on when to perform these.

Interventions

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Standard of Care advice on physical activity

Oral advice on exercise from a physician.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role collaborator

Karolinska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hannes Hagström

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hannes Hagström, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska University Hospital

Locations

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Karolinska University Hospital

Stockholm, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Hannes Hagström, MD PhD

Role: CONTACT

0046858580000

Andrea Lindfors, MD

Role: CONTACT

Facility Contacts

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Hannes Hagström, MD, PhD

Role: primary

0046858580000

Other Identifiers

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2021-04454

Identifier Type: -

Identifier Source: org_study_id

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