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

March 29, 2016 updated by: Ottawa Hospital Research Institute
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Recruiting
        • The Ottawa Hospital
        • Contact:
        • Principal Investigator:
          • Doug A McKim, MD
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V2H1
        • Recruiting
        • Hôpital Charles-LeMoyne
        • Contact:
        • Principal Investigator:
          • Nadim Srour, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lung volume recruitment
Lung volume recruitment twice daily for 9 months
Procedure: 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
Other Names:
  • Air stacking
  • Glossophayngeal breathing
No Intervention: Standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of decline of FVC (forced vital capacity)
Time Frame: up to 9 months
up to 9 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Rate of decline of peak cough flow
Time Frame: baseline, 2, 4, 6 and 9 months
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
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
baseline vs 2, 4, 6 and 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ottawa Hospital Research Institute

Collaborators

The Ottawa Hospital

Investigators

  • Study Chair: Nadim Srour, MD, MSc, Université de Sherbrooke
  • Principal Investigator: Douglas A McKim, MD, The Ottawa Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Anticipated)

April 1, 2017

Study Completion (Anticipated)

April 1, 2017

Study Registration Dates

First Submitted

February 25, 2013

First Submitted That Met QC Criteria

July 1, 2013

First Posted (Estimate)

July 2, 2013

Study Record Updates

Last Update Posted (Estimate)

March 31, 2016

Last Update Submitted That Met QC Criteria

March 29, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS-LVR-01
  • 20120570-01H (Other Identifier: Ottawa Hospital Research Ethics Board)
  • AA-HCLM-14-019 (Other Identifier: Comité d'éthique de la recherche du Centre de santé et services sociaux Champlain-Charles LeMoyne)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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