Respiratory Muscle Training in Stroke Swallowing Disorders

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2020-09-16

Brief Summary

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Clinical randomized clinical trial to assess the effectiveness of incorporating inspiratory and expiratory muscle training (IEMT) in the rehabilitation of stroke patients with dysphagia in terms of functional outcomes, comorbidities, survival and quality of life.

This project also incorporates a longitudinal study to assess the clinical impact of dysphagia on body composition and nutritional status in stroke patients.

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Detailed Description

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Stroke is a major cause of morbidity and mortality worldwide. Stroke can lead to varying degrees of oropharyngeal dysphagia (25-85% of patients) and respiratory muscle dysfunction associated with an increase in medical complications such as bronchoaspiration, malnutrition and death. Dysphagia is present in a significant proportion of patients admitted to Rehabilitation (up to 85% depending on series) in stroke. Standard swallow therapy consists of educational intervention aimed to improve self-management of dysphagia and protect the airway, oral exercises to improve lingual praxis, and compensatory techniques based on videofluoroscopic findings. Recent studies suggest that IEMT can improve swallowing efficacy and reduce eventual bronchoaspiration events.

Nutritional status appears in 9-67% of patients with acute and subacute stroke and has an impact on functional outcomes and provides information about the risk of hospitalization and death. Stroke patients are at risk of developing malnutrition because of neurologic impairments related to feeding (chewing, deglutition and self-feeding) that can result in a poor food intake. To date, there is only few studies on prevalence and influence of malnutrition in stroke.

Conditions

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Swallowing Disorder Stroke Respiratory Muscle Training Malnutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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High intensity IEMT

Inspiratory and expiratory muscle training + standard swallow therapy.

Group Type EXPERIMENTAL

High intensity IEMT

Intervention Type DEVICE

Training load will be the maximum inspiratory / expiratory load defined according to patient tolerance equivalent to 10 maximal repetitions (RM) as 10 consecutive inspirations / expirations (x 5 set), three times per day, during 8 weeks. External loads will be increased weekly at intervals of 10 cm H2O as tolerated. Patients will receive standard swallow therapy consisting of swallowing manoeuvres, oral exercises, and compensatory techniques aimed to improve self-management of dysphagia and protect the airway.

Sham IEMT

Sham inspiratory and expiratory muscle training + standard swallow therapy

Group Type SHAM_COMPARATOR

Sham IEMT

Intervention Type DEVICE

5 sets of 10 inspirations and expirations in a sham IEMT trainer, three times a day, during 8 weeks.

Interventions

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High intensity IEMT

Training load will be the maximum inspiratory / expiratory load defined according to patient tolerance equivalent to 10 maximal repetitions (RM) as 10 consecutive inspirations / expirations (x 5 set), three times per day, during 8 weeks. External loads will be increased weekly at intervals of 10 cm H2O as tolerated. Patients will receive standard swallow therapy consisting of swallowing manoeuvres, oral exercises, and compensatory techniques aimed to improve self-management of dysphagia and protect the airway.

Intervention Type DEVICE

Sham IEMT

5 sets of 10 inspirations and expirations in a sham IEMT trainer, three times a day, during 8 weeks.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* First-ever Ischemic or haemorrhagic stroke
* Time since stroke onset: 1 month
* Dysphagia confirmed by videofluoroscopic study with a score \>3 in the 8-point Penetration Aspiration Scale.
* Mini-mental State Exploration \> 24)

Exclusion Criteria

* Aphasia
* History of cardiopulmonary disease; neurologic condition other than stroke and metabolic disease
* Medical treatment with potential effect on muscle structure and function

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No