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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01891071

Enrollment

Registered

2013-07-02

Start date

2013-07-31

Completion date

2017-04-30

Last updated

2016-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

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

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.

Interventions

PROCEDURELung 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Rate of decline of FVC (forced vital capacity)	up to 9 months

Secondary

Measure	Time frame
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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026