Respiratory Muscle Training in Stroke Swallowing Disorders "RETORNUS-2"

Recruiting

Phase N/A Results N/A

Trial Description

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.

Detailed 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 bronchoaspirative 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

Interventions

  • High intensity IEMT Device
    Intervention Desc: 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), twice a 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.
    ARM 1: Kind: Experimental
    Label: High intensity IEMT
    Description: Inspiratory and expiratory muscle training + standard swallow therapy.
  • Sham IEMT Device
    Intervention Desc: 5 sets of 10 inspirations and expirations in a sham IEMT trainer, twice a day, during 8 weeks.
    ARM 1: Kind: Experimental
    Label: Sham IEMT
    Description: Sham inspiratory and expiratory muscle training + standard swallow therapy

Outcomes

Type Measure Time Frame Safety Issue
Primary Change in respiratory muscle strength Baseline and weekly during 8 weeks
Primary Change in dysphagia severity Baseline, 8 weeks, 6 months post-stroke
Secondary Change in tongue strength Baseline and weekly during 8 weeks
Secondary Change in fat-free mass Baseline, 3 months and 6 months post-stroke
Secondary Malnutrition at 6 months Baseline and 6 months post-stroke

Sponsors