A pilot study of respiratory muscle training to improve cough effectiveness and reduce the incidence of pneumonia in acute stroke: study protocol for a randomized controlled trialReport as inadecuate

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, 15:123

First Online: 12 April 2014Received: 20 January 2014Accepted: 28 March 2014DOI: 10.1186-1745-6215-15-123

Cite this article as: Kulnik, S.T., Rafferty, G.F., Birring, S.S. et al. Trials 2014 15: 123. doi:10.1186-1745-6215-15-123


BackgroundAfter stroke, pneumonia is a relevant medical complication that can be precipitated by aspiration of saliva, liquids, or solid food. Swallowing difficulty and aspiration occur in a significant proportion of stroke survivors. Cough, an important mechanism protecting the lungs from inhaled materials, can be impaired in stroke survivors, and the likely cause for this impairment is central weakness of the respiratory musculature. Thus, respiratory muscle training in acute stroke may be useful in the recovery of respiratory muscle and cough function, and may thereby reduce the risk of pneumonia. The present study is a pilot study, aimed at investigating the validity and feasibility of this approach by exploring effect size, safety, and patient acceptability of the intervention.

Methods-designAdults with moderate to severe stroke impairment National Institutes of Health Stroke Scale NIHSS score 5 to 25 at the time of admission are recruited within 2 weeks of stroke onset. Participants must be able to perform voluntary respiratory maneuvers. Excluded are patients with increased intracranial pressure, uncontrolled hypertension, neuromuscular conditions other than stroke, medical history of asthma or chronic obstructive pulmonary disease, and recent cardiac events. Participants are randomized to receive inspiratory, expiratory, or sham respiratory training over a 4-week period, by using commercially available threshold resistance devices. Participants and caregivers, but not study investigators, are blind to treatment allocation. All participants receive medical care and stroke rehabilitation according to the usual standard of care. The following assessments are conducted at baseline, 4 weeks, and 12 weeks: Voluntary and reflex cough flow measurements, forced spirometry, respiratory muscle strength tests, incidence of pneumonia, assessments of safety parameters, and self-reported activity of daily living. The primary outcome is peak expiratory cough flow of voluntary cough, a parameter indicating the effectiveness of cough. Secondary outcomes are incidence of pneumonia, peak expiratory cough flow of reflex cough, and maximum inspiratory and expiratory mouth pressures.

DiscussionVarious novel pharmacologic and nonpharmacologic approaches for preventing stroke-associated pneumonia are currently being researched. This study investigates a novel strategy based on an exercise intervention for cough rehabilitation.

Trial registrationCurrent Controlled Trials ISRCTN40298220

KeywordsRespiratory muscle training Prevention Pneumonia Stroke Cough Rehabilitation AbbreviationsACEangiotensin converting enzyme

ADLActivity of daily living

ANCOVAanalysis of covariance

ANOVAanalysis of variance

COPDchronic obstructive pulmonary disease

CTcomputed tomography

FEVforced expiratory volume

FEV1forced expiratory volume in 1 second

IDinternal diameter

IMTinspiratory muscle trainer

MEPmaximum expiratory mouth pressure

MIPmaximum inspiratory mouth pressure

NHSNational Health Service

NIHRNational Institute for Health Research

NIHSSNational Institutes of Health Stroke Scale

NRESNational Research Ethics Service

PECFpeak expiratory cough flow

PEFpeak expiratory flow

PEPpositive expiratory pressure

PICFpeak inspiratory cough flow

RMTrespiratory muscle training

SDstandard deviation

UKUnited Ki ngdom

USAUnited States of America

VEvolume expired

VIvolume inspired.

Electronic supplementary materialThe online version of this article doi:10.1186-1745-6215-15-123 contains supplementary material, which is available to authorized users.

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Author: Stefan Tino Kulnik - Gerrard Francis Rafferty - Surinder S Birring - John Moxham - Lalit Kalra

Source: https://link.springer.com/

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