Respiratory Muscle Training in Stroke Swallowing Disorders

Not Applicable

Terminated

• Conditions: Malnutrition; Swallowing Disorder; Respiratory Muscle Training; Stroke
• Interventions: Device: High intensity IEMT; Device: Sham IEMT

• Registration Number: NCT03021252
• Lead Sponsor: Parc de Salut Mar

Brief Summary

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 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.

Study Timeline

• Study First Submitted: 2017-01-10
• Study First Submitted QC: 2017-01-11
• Study First Posted: 2017-01-13
• Study Start: 2017-03-01
• Status Verified: 2019-09
• Primary Completion: 2020-02-01
• Study Completion: 2020-09-16
• Last Update Submitted: 2020-09-18
• Last Update Posted: 2020-09-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High intensity IEMT	High intensity IEMT	Inspiratory and expiratory muscle training + standard swallow therapy.
Sham IEMT	Sham IEMT	Sham inspiratory and expiratory muscle training + standard swallow therapy

Primary Outcome Measures

Name	Time	Method
Change in respiratory muscle strength	Baseline and weekly during 8 weeks	Respiratory muscle strength is assessed through maximal inspiratory and expiratory pressures (PImax and PEmax, respectively) using a pressure transducer connected to a digital register system. The PImax is measured at mouth during a maximum effort from residual volume against occluded airway. To determine the PEmax, the patients will perform a maximum expiratory effort from total lung capacity (TLC) in the face of the occluded airway. A specific and validated respiratory pressures manometer will be used (Micro RPM, Cardinalhealth, Kent, UK).
Change in dysphagia severity	Baseline, 8 weeks, 6 months post-stroke	Dysphagia severity is assessed with the Penetration-Aspiration Scale: scores of 1-2 indicate normal swallowing; 3-5, penetration; \>6, aspiration.

Secondary Outcome Measures

Name	Time	Method
Change in tongue strength	Baseline and weekly during 8 weeks	Lingual Force (IOPI system): maximum isometric tongue pressure defined as the highest of the three peak isometric tongue pressure scores.
Change in fat-free mass	Baseline, 3 months and 6 months post-stroke	Fat-free mass measured by electrical bioimpedance in kilograms and expressed as normal, low or high values according to normal values for the reference population
Malnutrition at 6 months	Baseline and 6 months post-stroke	Malnutrition criteria of the European Society of Clinical Nutrition and Metabolism (ESPEN)

Trial Locations

Locations (2)

Physical Medicine & Rehabilitation Dpt. Parc de Salut Mar.; 🇪🇸 Barcelona, Spain

Hospital de l'Esperança; 🇪🇸 Barcelona, Catalonia, Spain