Respiratory Muscle Training in Stroke Swallowing Disorders (RETORNUS-2)
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|ClinicalTrials.gov Identifier: NCT03021252|
Recruitment Status : Terminated (Because of the SARS-COV2 pandemic. Recruitment stopped at 48 patients)
First Posted : January 13, 2017
Last Update Posted : September 22, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Swallowing Disorder Stroke Respiratory Muscle Training Malnutrition||Device: High intensity IEMT Device: Sham IEMT||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||The RETORNUS-2 Study: Impact of Respiratory Muscle Training on Swallowing Disorders in Stroke Patients|
|Actual Study Start Date :||March 1, 2017|
|Actual Primary Completion Date :||February 1, 2020|
|Actual Study Completion Date :||September 16, 2020|
Experimental: High intensity IEMT
Inspiratory and expiratory muscle training + standard swallow therapy.
Device: 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.
Sham Comparator: Sham IEMT
Sham inspiratory and expiratory muscle training + standard swallow therapy
Device: Sham IEMT
5 sets of 10 inspirations and expirations in a sham IEMT trainer, three times a day, during 8 weeks.
- Change in respiratory muscle strength [ Time Frame: 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 [ Time Frame: 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.
- Change in tongue strength [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline and 6 months post-stroke ]Malnutrition criteria of the European Society of Clinical Nutrition and Metabolism (ESPEN)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03021252
|Hospital de l'Esperança|
|Barcelona, Catalonia, Spain, 08024|
|Physical Medicine & Rehabilitation Dpt. Parc de Salut Mar.|
|Barcelona, Spain, 08024|
|Principal Investigator:||Anna Guillén-Solà, MD, PhD||Fundació IMIM - Parc de Salut Mar|