Respiratory Muscle Training in Stroke Swallowing Disorders (RETORNUS-2)

Parc de Salut Mar

Status

Terminated

Conditions

Malnutrition

Stroke

Respiratory Muscle Training

Swallowing Disorder

Treatments

Device: Sham IEMT

Device: High intensity IEMT

Study type

Interventional

Funder types

Other

Identifiers

NCT03021252

PSM/RHB/NR21

Details and patient eligibility

About

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.

Full description

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.

Enrollment

50 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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