Lung Volume Recruitment for Lung Function and Cough Impairment in Multiple Sclerosis
3 other identifiers
interventional
35
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable multiple-sclerosis
Started Jul 2013
Longer than P75 for not_applicable multiple-sclerosis
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2013
CompletedStudy Start
First participant enrolled
July 1, 2013
CompletedFirst Posted
Study publicly available on registry
July 2, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2017
CompletedMarch 31, 2016
March 1, 2016
3.8 years
February 25, 2013
March 29, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of decline of FVC (forced vital capacity)
up to 9 months
Secondary Outcomes (3)
Rate of decline of peak cough flow
baseline, 2, 4, 6 and 9 months
Change from baseline in FVC at 2, 4, 6 and 9 months
baseline vs 2, 4, 6 and 9 months
Change from baseline in peak cough flow at 2, 4, 6 and 9 months
baseline vs 2, 4, 6 and 9 months
Study Arms (2)
Lung volume recruitment
EXPERIMENTALLung volume recruitment twice daily for 9 months
Standard care
NO INTERVENTIONStandard care
Interventions
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
Eligibility Criteria
You may qualify if:
- History of multiple sclerosis, diagnosed by a neurologist in accordance with the 2010 McDonald criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ottawa Hospital Research Institutelead
- The Ottawa Hospitalcollaborator
Study Sites (2)
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6, Canada
Hôpital Charles-LeMoyne
Greenfield Park, Quebec, J4V2H1, Canada
Related Publications (1)
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.
PMID: 23383293BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Nadim Srour, MD, MSc
Université de Sherbrooke
- PRINCIPAL INVESTIGATOR
Douglas A McKim, MD
The Ottawa Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2013
First Posted
July 2, 2013
Study Start
July 1, 2013
Primary Completion
April 1, 2017
Study Completion
April 1, 2017
Last Updated
March 31, 2016
Record last verified: 2016-03