CirrhosisNCT02267421
Effects of Home Based Exercise Therapy in Early Cirrhosis
A study testing Home based Aerobic exercise training in people with Cirrhosis, run by University of Alberta at 1 site in Canada.
Trial summary
Individuals with Cirrhosis have been shown to have a low aerobic capacity. While supervised exercise training has been shown to be an effective intervention to remedy this, there is currently no data on home based exercise interventions in this population. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cirrhosis
- What is being tested?
- Home based Aerobic exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 and less than or equal to 70 years Liver Cirrhosis Child Pugh Class A or B If required, primary or secondary Variceal prophylaxis in place
Who cannot join
- Post-liver transplantation Hepatocellular carcinoma beyond transplant criteria Active non-hepatocellular carcinoma malignancy Significant cardiac disease Hemoglobin (<80 g/L) Oxygen saturation at rest <95% Known myopathy Chronic renal failure on dialysis Physical impairment making it impossible to ride an exercise bike or treadmill Orthopedic abnormality preventing exercise training HIV infection Patient unwilling to consent to study Child Pugh class C
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Alberta, Mazankowski Heart Institute
Edmonton, Alberta, T6G2B1
About this study
Official title: An 8 Week Randomized Controlled Trial Assessing Home Exercise Therapy in Early Cirrhosis
Individuals with Cirrhosis have been shown to have a low aerobic capacity. While supervised exercise training has been shown to be an effective intervention to remedy this, there is currently no data on home based exercise interventions in this population. This study will evaluate the effects of a home based exercise program on the aerobic capacity of enrolled early stage liver cirrhosis patients, as well as changes in quality of life, thigh muscle thickness, and thigh muscle oxygen consumption.
- Conditions
- Cirrhosis
- Being tested
- Home based Aerobic exercise training
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home based Aerobic exercise trainingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Home based aerobic exercise | Experimental | Home based aerobic exercise on cycle ergometer. Three times per week, 30-60 minutes per session. Receives: Behavioral: Home based Aerobic exercise training |
| Usual Care group | No intervention | These patients will continue with their normal activities of daily living and will not be provided with equipment or coaching for home based exercise during the study period . |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in peak exercise pulmonary oxygen uptake (VO2peak).
Measured: Baseline (day 1) and Study End (8 weeks)
Secondary outcomes (3)
Change in muscle mass as measured by thigh ultrasound
Measured: Baseline (day 1) and Study end (8 weeks)
Change in quality of life - Chronic Liver Disease Questionnaire
Measured: Baseline (Day 1) and Study completion (8 weeks)
Change in muscle oxygen extraction and consumption as measured by MRI
Measured: Baseline (day 1) and study completion (8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02267421
- Sponsor's protocol ID
- CKPTMHLivCirHomeTraining
- Status last verified
- Apr 2022
- First submitted
- 14 Oct 2014
- Last updated
- 11 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An 8 Week Randomized Controlled Trial Assessing Home Exercise Therapy in Early Cirrhosis
- ClinicalTrials.gov ID
- NCT02267421
- Acronym / sponsor ID
- CKPTMHLivCirHomeTraining
- Conditions
- Cirrhosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 17 Oct 2014 (estimated)
- 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.
Individuals with Cirrhosis have been shown to have a low aerobic capacity. While supervised exercise training has been shown to be an effective intervention to remedy this, there is currently no data on home based exercise interventions in this population. This study will evaluate the effects of a home based exercise program on the aerobic capacity of enrolled early stage liver cirrhosis patients, as well as changes in quality of life, thigh muscle thickness, and thigh muscle oxygen consumption.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home based aerobic exercise | Experimental | Behavioral: Home based Aerobic exercise trainingHome based aerobic exercise on cycle ergometer. Three times per week, 30-60 minutes per session. |
| Usual Care group | No intervention | –These patients will continue with their normal activities of daily living and will not be provided with equipment or coaching for home based exercise during the study period . |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age >18 and less than or equal to 70 years Liver Cirrhosis Child Pugh Class A or B If required, primary or secondary Variceal prophylaxis in place
Key exclusion criteria (1 listed)
- Post-liver transplantation Hepatocellular carcinoma beyond transplant criteria Active non-hepatocellular carcinoma malignancy Significant cardiac disease Hemoglobin (<80 g/L) Oxygen saturation at rest <95% Known myopathy Chronic renal failure on dialysis Physical impairment making it impossible to ride an exercise bike or treadmill Orthopedic abnormality preventing exercise training HIV infection Patient unwilling to consent to study Child Pugh class C
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 |
|---|---|---|
| Home based Aerobic exercise training | Behavioural | Home based aerobic exercise |
Primary outcome
Change in peak exercise pulmonary oxygen uptake (VO2peak).
Time frame: Baseline (day 1) and Study End (8 weeks)
3 secondary outcomes
Change in muscle mass as measured by thigh ultrasound
Time frame: Baseline (day 1) and Study end (8 weeks)
Change in quality of life - Chronic Liver Disease Questionnaire
Time frame: Baseline (Day 1) and Study completion (8 weeks)
Change in muscle oxygen extraction and consumption as measured by MRI
Time frame: Baseline (day 1) and study completion (8 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
- MedlinePlusLink provided by the sponsor.
- MedlinePlus CirrhosisLink provided by the sponsor.
- MedlinePlus Exercise and Physical FitnessLink provided by the sponsor.
- U.S. FDA ResourcesLink provided by the sponsor.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home based Aerobic exercise training in people with Cirrhosis, run by University of Alberta at 1 site in Canada.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 11 Apr 2022. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in peak exercise pulmonary oxygen uptake (VO2peak). (time frame: Baseline (day 1) and Study End (8 weeks)). 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 11 Apr 2022.