Multiple SclerosisNCT01891071
Lung Volume Recruitment for Lung Function and Cough Impairment in Multiple Sclerosis
A study testing Lung volume recruitment in people with Multiple Sclerosis, run by Ottawa Hospital Research Institute at 2 sites in Canada.
Trial summary
Multiple sclerosis is a neurological disease that can affect lung function and cough efficacy. This pilot study will examine whether the lung volume recruitment technique can slow down the decline in lung function and cough. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Lung volume recruitment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesCanada
- Study dates
- Jul 2013to Apr 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of multiple sclerosis, diagnosed by a neurologist in accordance with the 2010 McDonald criteria
Who cannot join
- Concomitant parenchymal pulmonary disease or pleural disease
- Symptomatic cardiomyopathy
- Unable to perform pulmonary function testing or lung volume recruitment, due to comprehension or cooperation issues, physical inability such as bulbar or cerebellar dysfunction
- Contra-indication to pulmonary function testing or lung volume recruitment such as myocardial infarction, bleeding aortic aneurysm, intracranial hemorrhage within the previous month
- Known susceptibility to pneumothorax or pneumomediastinum
- Not competent to provide informed consent
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 2 recruiting
- Recruiting
Hôpital Charles-LeMoyne
Greenfield Park, Quebec, J4V2H1
Nadim Srour, MD, 450-466-5000 ext. 2734, nadim.srour@usherbrooke.ca
Nadim Srour, MD
- Recruiting
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6
Doug A. McKim, MD, 613-737-8899 ext. 16448, dmckim@ottawahospital.on.ca
Doug A McKim, MD
About this study
Multiple sclerosis is a neurological disease that can affect lung function and cough efficacy. This pilot study will examine whether the lung volume recruitment technique can slow down the decline in lung function and cough.
- Conditions
- Multiple Sclerosis
- Being tested
- Lung volume recruitment
- Keywords
- Multiple sclerosis, Lung volume recruitment, Pulmonary function impairment, Cough impairment
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung volume recruitmentProcedure or surgery
Also called Air stacking, Glossophayngeal breathing
Inflation of the lungs to their maximal insufflation capacity by the consecutive delivery, by a manual resuscitator in this study, of volumes of air that are held with a closed glottis
| Study group | Role | What they receive |
|---|---|---|
| Lung volume recruitment | Experimental | Lung volume recruitment twice daily for 9 months Receives: Procedure: Lung volume recruitment |
| Standard care | No intervention | Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of decline of FVC (forced vital capacity)
Measured: up to 9 months
Secondary outcomes (3)
Rate of decline of peak cough flow
Measured: baseline, 2, 4, 6 and 9 months
Change from baseline in FVC at 2, 4, 6 and 9 months
Measured: baseline vs 2, 4, 6 and 9 months
Change from baseline in peak cough flow at 2, 4, 6 and 9 months
Measured: baseline vs 2, 4, 6 and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionApr 2017 (estimated)
- Study completionApr 2017 (estimated)
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 Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- The Ottawa Hospital
- Responsible party
- Sponsor
- Investigators
- Nadim Srour, MD, MSc, Study chair, Université de SherbrookeDouglas A McKim, MD, Principal investigator, The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01891071
- Sponsor's protocol ID
- MS-LVR-01
- Other IDs
- 20120570-01H, AA-HCLM-14-019
- Status last verified
- Mar 2016
- First submitted
- 25 Feb 2013
- Last updated
- 31 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Srour N, LeBlanc C, King J, McKim DA. Lung volume recruitment in multiple sclerosis. PLoS One. 2013;8(1):e56676. doi: 10.1371/journal.pone.0056676. Epub 2013 Jan 31.
PubMed 23383293
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Volume Recruitment for Lung Function and Cough Impairment in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01891071
- Acronym / sponsor ID
- MS-LVR-01
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis, Lung volume recruitment, Pulmonary function impairment, Cough impairment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- The Ottawa Hospital
- Study start
- Jul 2013
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 2 Jul 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.
Multiple sclerosis is a neurological disease that can affect lung function and cough efficacy. This pilot study will examine whether the lung volume recruitment technique can slow down the decline in lung function and cough.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lung volume recruitment | Experimental | Procedure: Lung volume recruitmentLung volume recruitment twice daily for 9 months |
| Standard care | No intervention | –Standard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- History of multiple sclerosis, diagnosed by a neurologist in accordance with the 2010 McDonald criteria
Key exclusion criteria (6 listed)
- Concomitant parenchymal pulmonary disease or pleural disease
- Symptomatic cardiomyopathy
- Unable to perform pulmonary function testing or lung volume recruitment, due to comprehension or cooperation issues, physical inability such as bulbar or cerebellar dysfunction
- Contra-indication to pulmonary function testing or lung volume recruitment such as myocardial infarction, bleeding aortic aneurysm, intracranial hemorrhage within the previous month
- Known susceptibility to pneumothorax or pneumomediastinum
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 |
|---|---|---|
| Lung volume recruitmentAlso: Air stacking, Glossophayngeal breathingInflation of the lungs to their maximal insufflation capacity by the consecutive delivery, by a manual resuscitator in this study, of volumes of air that are held with a closed glottis | Procedure or surgery | Lung volume recruitment |
Primary outcome
Rate of decline of FVC (forced vital capacity)
Time frame: up to 9 months
3 secondary outcomes
Rate of decline of peak cough flow
Time frame: baseline, 2, 4, 6 and 9 months
Change from baseline in FVC at 2, 4, 6 and 9 months
Time frame: baseline vs 2, 4, 6 and 9 months
Change from baseline in peak cough flow at 2, 4, 6 and 9 months
Time frame: baseline vs 2, 4, 6 and 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2016.
- Background: PubMed 23383293Srour N, LeBlanc C, King J, McKim DA. Lung volume recruitment in multiple sclerosis. PLoS One. 2013;8(1):e56676. doi: 10.1371/journal.pone.0056676. Epub 2013 Jan 31.
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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.
Nadim Srour, MD, MSc study chair
Université de Sherbrooke
Douglas A McKim, MD principal investigator
The Ottawa Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lung volume recruitment in people with Multiple Sclerosis, run by Ottawa Hospital Research Institute at 2 sites 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 6 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: status not confirmed, as of the sponsor's last update on 31 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of decline of FVC (forced vital capacity) (time frame: up to 9 months). 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 NCT01891071, 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 31 Mar 2016.