Liver CirrhosisINSPELNCT05061576
Instructed Home-based Physical Exercise for Patients With Liver Cirrhosis
A study testing Structured advice on physical activity in people with Liver Cirrhosis, run by Karolinska University Hospital at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- Structured advice on physical activity
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- 16 Aug 2022to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Andrea Lindfors, MD contact
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University Hospital
Stockholm, 14186
Hannes Hagström, MD, PhD, 0046858580000, hannes.hagstrom@ki.se
About this study
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.
- Conditions
- Liver Cirrhosis
- Being tested
- Standard of Care advice on physical activity, Structured advice on physical activity
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of Care advice on physical activityBehavioural
Oral advice on exercise from a physician.
Structured advice on physical activityBehavioural
A leaflet with instructions and images on different forms of physical activities as well as clear recommendations on when to perform these.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | Active comparator | Oral advice on exercise from a physician. Receives: Behavioral: Standard of Care advice on physical activity |
| Active intervention | Experimental | A leaflet with instructions and images on different forms of physical activities as well as clear recommendations on when to perform these. Receives: Behavioral: Structured advice on physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 months
Secondary outcomes (3)
Frailty
Frailty as measured with the Liver Frailty Index.
Measured: 3 months
MELD
Model of End-stage Liver Disease score (range 6-40, a higher score indicates a worse prognosis)
Measured: 3 months
Mortality
Overall mortality
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2021
- Study start16 Aug 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet
- Responsible party
- Principal investigator, Hannes Hagström, Karolinska University Hospital
- Investigators
- Hannes Hagström, MD PhD, Principal investigator, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05061576
- Sponsor's protocol ID
- 2021-04454
- Acronym
- INSPEL
- Status last verified
- Oct 2023
- First submitted
- 9 Sep 2021
- Last updated
- 4 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Instructed Home-based Physical Exercise for Patients With Liver Cirrhosis
- ClinicalTrials.gov ID
- NCT05061576
- Acronym / sponsor ID
- INSPEL / 2021-04454
- Conditions
- Liver Cirrhosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- Karolinska Institutet
- Study start
- 16 Aug 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care | Active comparator | Behavioral: Standard of Care advice on physical activityOral advice on exercise from a physician. |
| Active intervention | Experimental | Behavioral: Structured advice on physical activityA leaflet with instructions and images on different forms of physical activities as well as clear recommendations on when to perform these. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of Care advice on physical activityOral advice on exercise from a physician. | Behavioural | Standard of care |
| Structured advice on physical activityA leaflet with instructions and images on different forms of physical activities as well as clear recommendations on when to perform these. | Behavioural | Active intervention |
Primary outcome
Change in quality of life summary score, as measured with the CLDQ tool
Time frame: 3 months
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 secondary outcomes
Frailty
Time frame: 3 months
MELD
Time frame: 3 months
Mortality
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrea Lindfors, MD contact
Hannes Hagström, MD PhD principal investigator
Karolinska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured advice on physical activity in people with Liver Cirrhosis, run by Karolinska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hannes Hagström, MD PhD (0046858580000, hannes.hagstrom@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in quality of life summary score, as measured with the CLDQ tool (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2023.