Lung Volume Recruitment for Lung Function and Cough Impairment in Multiple Sclerosis

NCT ID: NCT01891071

Last Updated: 2016-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2017-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Lung volume recruitment

Lung volume recruitment twice daily for 9 months

Group Type EXPERIMENTAL

Lung volume recruitment

Intervention Type PROCEDURE

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

Standard care

Standard care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Lung volume recruitment

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

Intervention Type PROCEDURE

Other Intervention Names

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Air stacking Glossophayngeal breathing

Eligibility Criteria

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Inclusion Criteria

* History of multiple sclerosis, diagnosed by a neurologist in accordance with the 2010 McDonald criteria

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Ottawa Hospital

OTHER

Sponsor Role collaborator

Ottawa Hospital Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nadim Srour, MD, MSc

Role: STUDY_CHAIR

Université de Sherbrooke

Douglas A McKim, MD

Role: PRINCIPAL_INVESTIGATOR

The Ottawa Hospital

Locations

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The Ottawa Hospital

Ottawa, Ontario, Canada

Site Status RECRUITING

Hôpital Charles-LeMoyne

Greenfield Park, Quebec, Canada

Site Status RECRUITING

Countries

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Canada

Facility Contacts

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Doug A. McKim, MD

Role: primary

613-737-8899 ext. 16448

Nadim Srour, MD

Role: primary

450-466-5000 ext. 2734

References

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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.

Reference Type BACKGROUND
PMID: 23383293 (View on PubMed)

Other Identifiers

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20120570-01H

Identifier Type: OTHER

Identifier Source: secondary_id

AA-HCLM-14-019

Identifier Type: OTHER

Identifier Source: secondary_id

MS-LVR-01

Identifier Type: -

Identifier Source: org_study_id

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