Respiratory Muscle Training in Stroke Swallowing Disorders

Stroke Clinical Trial

— RETORNUS-2  

Official title:

The RETORNUS-2 Study: Impact of Respiratory Muscle Training on Swallowing Disorders in Stroke Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03021252
• Other study ID #: PSM/RHB/NR21
• Status: Terminated
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: September 16, 2020

Study information

• Verified date: September 2019
• Source: Parc de Salut Mar
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: September 16, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Deglutition Disorders
• Malnutrition
• Respiratory Muscle Training
• Stroke
• Swallowing Disorder

Intervention

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 IEMT
5 sets of 10 inspirations and expirations in a sham IEMT trainer, three times a day, during 8 weeks.

Locations

Country	Name	City	State
Spain	Hospital de l'Esperança	Barcelona	Catalonia
Spain	Physical Medicine & Rehabilitation Dpt. Parc de Salut Mar.	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Parc de Salut Mar	Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

References & Publications (5)

Burgos R, Sarto B, Elío I, Planas M, Forga M, Cantón A, Trallero R, Muñoz MJ, Pérez D, Bonada A, Saló E, Lecha M, Enrich G, Salas-Salvadó J; Group for the Study of Malnutrition in Hospitals in Catalonia. Prevalence of malnutrition and its etiological factors in hospitals. Nutr Hosp. 2012 Mar-Apr;27(2):469-76. doi: 10.1590/S0212-16112012000200018. — View Citation

Guillén-Solà A, Messagi Sartor M, Bofill Soler N, Duarte E, Barrera MC, Marco E. Respiratory muscle strength training and neuromuscular electrical stimulation in subacute dysphagic stroke patients: a randomized controlled trial. Clin Rehabil. 2017 Jun;31(6):761-771. doi: 10.1177/0269215516652446. Epub 2016 Jun 7. — View Citation

Kulnik ST, Birring SS, Moxham J, Rafferty GF, Kalra L. Does respiratory muscle training improve cough flow in acute stroke? Pilot randomized controlled trial. Stroke. 2015 Feb;46(2):447-53. doi: 10.1161/STROKEAHA.114.007110. Epub 2014 Dec 11. — View Citation

Martino R, Foley N, Bhogal S, Diamant N, Speechley M, Teasell R. Dysphagia after stroke: incidence, diagnosis, and pulmonary complications. Stroke. 2005 Dec;36(12):2756-63. Epub 2005 Nov 3. Review. — View Citation

Messaggi-Sartor M, Guillen-Solà A, Depolo M, Duarte E, Rodríguez DA, Barrera MC, Barreiro E, Escalada F, Orozco-Levi M, Marco E. Inspiratory and expiratory muscle training in subacute stroke: A randomized clinical trial. Neurology. 2015 Aug 18;85(7):564-72. doi: 10.1212/WNL.0000000000001827. Epub 2015 Jul 15. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in respiratory muscle strength	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).	Baseline and weekly during 8 weeks
Primary	Change in dysphagia severity	Dysphagia severity is assessed with the Penetration-Aspiration Scale: scores of 1-2 indicate normal swallowing; 3-5, penetration; >6, aspiration.	Baseline, 8 weeks, 6 months post-stroke
Secondary	Change in tongue strength	Lingual Force (IOPI system): maximum isometric tongue pressure defined as the highest of the three peak isometric tongue pressure scores.	Baseline and weekly during 8 weeks
Secondary	Change in fat-free mass	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	Baseline, 3 months and 6 months post-stroke
Secondary	Malnutrition at 6 months	Malnutrition criteria of the European Society of Clinical Nutrition and Metabolism (ESPEN)	Baseline and 6 months post-stroke