Abstract

BackgroundStroke can lead to varying degrees of oropharyngeal dysphagia, respiratory muscle dysfunction and even increase medical complications such as aspiration, malnutrition and death. Recent studies suggest that inspiratory and expiratory respiratory muscle training (IEMT) can improve swallowing efficacy and may reduce aspiration events. The main purpose of this study is to examine whether an 8-week IEMT programme can improve respiratory muscle strength and swallow dysfunction severity in subacute stroke patients with dysphagia.MethodsRetornus-2 is a two-arm, prospectively registered, randomized controlled study with blinded assessors and the participation of fifty individuals who have suffered a stroke. The intervention group undergoes IEMT training consisting of 5 sets of 10 repetitions, three times a day for 8 weeks. Training loads increase weekly. The control group undergoes a sham-IEMT protocol. The primary outcome examines the efficacy of the IEMT protocol to increase respiratory muscle strength and reduce dysphagia severity. The secondary outcome assesses the longitudinal impact of dysphagia on body composition and nutritional assessment over a 6-month follow-up.DiscussionIEMT induces an improvement in respiratory muscle strength and might be associated with relevant benefits in dysphagia patterns, as well as a reduction in the number of aspiration events confirmed by videofluoroscopy or fiberoptic endoscopic evaluation of swallowing. The description of the impact of swallowing impairment on nutritional status will help develop new strategies to face this known side-effect.Trial registrationClinicaltrials.gov NCT03021252. Registered on 10 January 2017. https://clinicaltrials.gov/ct2/results?cond=retornus+2&term=&cntry=ES&state=&city=&dist=WHO trial Registration data set: Due to heavy traffic generated by the COVID-19 outbreak, the ICTRP Search Portal does not respond. The portal recommends other registries such as clinicaltrials.gov. Protocol version: RETORNUS 2_ PROTOCOL_2.

Highlights

  • Stroke is one of the major causes of disability in adults, being an important public health concern [1]

  • Some authors tested a dual training programme for inspiratory and expiratory muscle training (IEMT) and concluded that IEMT induces significant improvement in inspiratory and expiratory muscle strength. This could potentially offer an additional therapeutic tool aimed at reducing respiratory complications at 6 months in stroke patients [5] while providing class II evidence of this practice

  • This study is an attempt to evaluate the effect of IEMT on respiratory muscle function and dysphagia severity

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Summary

Introduction

Stroke is one of the major causes of disability in adults, being an important public health concern [1]. The incidence of aspiration pneumonia in medical wards and rehabilitation units ranges from 3.9 to 45%, with a median rate of 7.4% [2]. Considering the variability of outcomes to stroke-related dysphagia, to improve protocols for an early detection and to provide an efficient treatment might reduce respiratory complications and reduce other health care expenditures [8]. Stroke can lead to varying degrees of oropharyngeal dysphagia, respiratory muscle dysfunction and even increase medical complications such as aspiration, malnutrition and death. Recent studies suggest that inspiratory and expiratory respiratory muscle training (IEMT) can improve swallowing efficacy and may reduce aspiration events. The main purpose of this study is to examine whether an 8-week IEMT programme can improve respiratory muscle strength and swallow dysfunction severity in subacute stroke patients with dysphagia

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