CirrhosisNCT01799785
Effects of Aerobic Training on Exercise Capacity in Patients With Cirrhosis
A study testing Aerobic exercise in people with Cirrhosis, run by University of Alberta at 1 site in Canada.
Trial summary
Cirrhosis is associated with a reduction in muscle mass and exercise capacity. This has an impact or morbidity and mortality. Regular aerobic exercise training is a proven effective therapy to improve exercise capacity in healthy and clinical populations. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cirrhosis
- What is being tested?
- Aerobic exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2013to Jul 2013
- 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 ≤70 years
- Cirrhosis
- Child Pugh class A or B
- If required, primary or secondary variceal prophylaxis in place
Who cannot join
- Post-liver transplantation
- Hepatocellular carcinoma
- Active non-Hepatocellular carcinoma malignancy
- Significant cardiac disease - ejection fraction <60% or known coronary artery disease
- Oxygen saturation at rest <95%
- Known myopathy
Show all 12Show fewer
- Hemoglobin (<100 g/L)
- 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
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: Aerobic Training in Patients With Cirrhosis
Cirrhosis is associated with a reduction in muscle mass and exercise capacity. This has an impact or morbidity and mortality. Regular aerobic exercise training is a proven effective therapy to improve exercise capacity in healthy and clinical populations. the effect of this training has not yet been evaluated in cirrhosis. The safety of this intervention also requires further study. Using a randomized controlled design, the investigators aim to conduct a pilot study evaluating the safety and efficacy of eight weeks of aerobic exercise training on aerobic capacity.
- Conditions
- Cirrhosis
- Being tested
- Aerobic exercise, Usual Care
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exerciseBehavioural
Aerobic exercise for 8 weeks (3 times per week, 30-60 minutes each session)
Usual CareOther
| Study group | Role | What they receive |
|---|---|---|
| Aerobic exercise | Experimental | Supervised aerobic training 3 times per week for 8 weeks (30-60 minute sessions) Receives: Behavioral: Aerobic exercise |
| Usual care group | Placebo comparator | These patients will continue with their normal daily activity and will not be provided with supervised aerobic exercise training during the study period. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in peak exercise pulmonary oxygen uptake (peak VO2)
Measured: Baseline (day 1) and Study End (8 weeks)
Secondary outcomes (2)
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 End (8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Puneeta Tandon, University of Alberta
- Investigators
- Mark Haykowsky, Study director, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01799785
- Sponsor's protocol ID
- LZPTMH1
- Status last verified
- Oct 2013
- First submitted
- 8 Feb 2013
- Last updated
- 9 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Zenith L, Meena N, Ramadi A, Yavari M, Harvey A, Carbonneau M, Ma M, Abraldes JG, Paterson I, Haykowsky MJ, Tandon P. Eight weeks of exercise training increases aerobic capacity and muscle mass and reduces fatigue in patients with cirrhosis. Clin Gastroenterol Hepatol. 2014 Nov;12(11):1920-6.e2. doi: 10.1016/j.cgh.2014.04.016. Epub 2014 Apr 24.
PubMed 24768811
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aerobic Training in Patients With Cirrhosis
- ClinicalTrials.gov ID
- NCT01799785
- Acronym / sponsor ID
- LZPTMH1
- Conditions
- Cirrhosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 27 Feb 2013 (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.
Cirrhosis is associated with a reduction in muscle mass and exercise capacity. This has an impact or morbidity and mortality. Regular aerobic exercise training is a proven effective therapy to improve exercise capacity in healthy and clinical populations. the effect of this training has not yet been evaluated in cirrhosis. The safety of this intervention also requires further study. Using a randomized controlled design, the investigators aim to conduct a pilot study evaluating the safety and efficacy of eight weeks of aerobic exercise training on aerobic capacity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic exercise | Experimental | Behavioral: Aerobic exerciseSupervised aerobic training 3 times per week for 8 weeks (30-60 minute sessions) |
| Usual care group | Placebo comparator | Other: Usual CareThese patients will continue with their normal daily activity and will not be provided with supervised aerobic exercise training 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 (4 listed)
- Age ≥18 and ≤70 years
- Cirrhosis
- Child Pugh class A or B
- If required, primary or secondary variceal prophylaxis in place
Key exclusion criteria (12 listed)
- Post-liver transplantation
- Hepatocellular carcinoma
- Active non-Hepatocellular carcinoma malignancy
- Significant cardiac disease - ejection fraction <60% or known coronary artery disease
- Oxygen saturation at rest <95%
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 |
|---|---|---|
| Aerobic exerciseAerobic exercise for 8 weeks (3 times per week, 30-60 minutes each session) | Behavioural | Aerobic exercise |
| Usual Care | Other | Usual care group |
Primary outcome
Change in peak exercise pulmonary oxygen uptake (peak VO2)
Time frame: Baseline (day 1) and Study End (8 weeks)
2 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 End (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 9 Oct 2013.
- Derived from this study: PubMed 24768811Zenith L, Meena N, Ramadi A, Yavari M, Harvey A, Carbonneau M, Ma M, Abraldes JG, Paterson I, Haykowsky MJ, Tandon P. Eight weeks of exercise training increases aerobic capacity and muscle mass and reduces fatigue in patients with cirrhosis. Clin Gastroenterol Hepatol. 2014 Nov;12(11):1920-6.e2. doi: 10.1016/j.cgh.2014.04.016. Epub 2014 Apr 24.
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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.
Mark Haykowsky study director
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise 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 4 inclusion and 12 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 9 Oct 2013. 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. Some participants in this study may receive a placebo. 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 (peak VO2) (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?
On the ClinicalTrials.gov record for NCT01799785, which also lists 1 linked publication.
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 9 Oct 2013.