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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborator:
Instituto de Salud Carlos III
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Swallowing Disorder Stroke Respiratory Muscle Training Malnutrition Device: High intensity IEMT Device: Sham IEMT Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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).

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. Malnutrition at 6 months [ Time Frame: Baseline and 6 months post-stroke ]
    Malnutrition criteria of the European Society of Clinical Nutrition and Metabolism (ESPEN)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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Spain
Hospital de l'Esperança
Barcelona, Catalonia, Spain, 08024
Physical Medicine & Rehabilitation Dpt. Parc de Salut Mar.
Barcelona, Spain, 08024
Sponsors and Collaborators
Parc de Salut Mar
Instituto de Salud Carlos III
Investigators
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Principal Investigator: Anna Guillén-Solà, MD, PhD Fundació IMIM - Parc de Salut Mar
Publications:
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Responsible Party: Parc de Salut Mar
ClinicalTrials.gov Identifier: NCT03021252    
Other Study ID Numbers: PSM/RHB/NR21
First Posted: January 13, 2017    Key Record Dates
Last Update Posted: September 22, 2020
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Deglutition Disorders
Stroke
Malnutrition
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Nutrition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases