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

Primary Purpose

Multiple Sclerosis

Status

Unknown status

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Lung volume recruitment

About this trial

This is an interventional prevention trial for Multiple Sclerosis focused on measuring Multiple sclerosis, Lung volume recruitment, Pulmonary function impairment, Cough impairment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

The Ottawa HospitalRecruiting
Hôpital Charles-LeMoyneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Lung volume recruitment

Standard care

Arm Description

Lung volume recruitment twice daily for 9 months

Standard care

Outcomes

Primary Outcome Measures

Rate of decline of FVC (forced vital capacity)

Secondary Outcome Measures

Rate of decline of peak cough flow

Change from baseline in FVC at 2, 4, 6 and 9 months

Change from baseline in peak cough flow at 2, 4, 6 and 9 months

Full Information

NCT ID

NCT01891071

First Posted

February 25, 2013

Last Updated

March 29, 2016

Sponsor

Ottawa Hospital Research Institute

Collaborators

The Ottawa Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01891071

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Unknown status

Study Start Date

July 2013 (undefined)

Primary Completion Date

April 2017 (Anticipated)

Study Completion Date

April 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ottawa Hospital Research Institute

Collaborators

The Ottawa Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis

Keywords

Multiple sclerosis, Lung volume recruitment, Pulmonary function impairment, Cough impairment

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Lung volume recruitment

Arm Type

Experimental

Arm Description

Lung volume recruitment twice daily for 9 months

Arm Title

Standard care

Arm Type

No Intervention

Arm Description

Standard care

Intervention Type

Procedure

Intervention Name(s)

Lung volume recruitment

Other Intervention Name(s)

Air stacking, Glossophayngeal breathing

Intervention Description

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

Primary Outcome Measure Information:

Title

Rate of decline of FVC (forced vital capacity)

Time Frame

up to 9 months

Secondary Outcome Measure Information:

Title

Rate of decline of peak cough flow

Time Frame

baseline, 2, 4, 6 and 9 months

Title

Change from baseline in FVC at 2, 4, 6 and 9 months

Time Frame

baseline vs 2, 4, 6 and 9 months

Title

Change from baseline in peak cough flow at 2, 4, 6 and 9 months

Time Frame

baseline vs 2, 4, 6 and 9 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nadim Srour, MD, MSc

Organizational Affiliation

Université de Sherbrooke

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Douglas A McKim, MD

Organizational Affiliation

The Ottawa Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Ottawa Hospital

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1H 8L6

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Doug A. McKim, MD

Phone

613-737-8899

Ext

16448

dmckim@ottawahospital.on.ca

First Name & Middle Initial & Last Name & Degree

Doug A McKim, MD

Facility Name

Hôpital Charles-LeMoyne

City

Greenfield Park

State/Province

Quebec

ZIP/Postal Code

J4V2H1

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nadim Srour, MD

Phone

450-466-5000

Ext

2734

nadim.srour@usherbrooke.ca

First Name & Middle Initial & Last Name & Degree

Nadim Srour, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

23383293

Citation

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.

Results Reference

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

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