Clinical trial NCT03021252: Respiratory Muscle Training in Stroke Swallowing Disorders
Official title: The RETORNUS-2 Study: Impact of Respiratory Muscle Training on Swallowing Disorders in Stroke Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Swallowing Disorder
Stroke
Respiratory Muscle Training
Malnutrition
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
First posted: 2017-01-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Change in respiratory muscle strength
timeFrame: Baseline and weekly during 8 weeks
measure: Change in dysphagia severity
timeFrame: Baseline, 8 weeks, 6 months post-stroke
Secondary outcomes:
measure: Change in tongue strength
timeFrame: Baseline and weekly during 8 weeks
measure: Change in fat-free mass
timeFrame: Baseline, 3 months and 6 months post-stroke
measure: Malnutrition at 6 months
timeFrame: Baseline and 6 months post-stroke
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de l'Esperança
state: Catalonia
city: Barcelona
country: Spain
facility: Physical Medicine & Rehabilitation Dpt. Parc de Salut Mar.
Study officials:
affiliation: Fundació IMIM - Parc de Salut Mar
name: Anna Guillén-Solà, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1161/01.STR.0000190056.76543.eb. Epub 2005 Nov 3.
citation: Guillen-Sola 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.
citation: Messaggi-Sartor M, Guillen-Sola A, Depolo M, Duarte E, Rodriguez 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.
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.
citation: Burgos R, Sarto B, Elio I, Planas M, Forga M, Canton A, Trallero R, Munoz MJ, Perez D, Bonada A, Salo E, Lecha M, Enrich G, Salas-Salvado 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.
citation: Guillen-Sola A, Messaggi-Sartor M, Ramirez-Fuentes C, Marco E, Duarte E. The Retornus-2 study: impact of respiratory muscle training in subacute stroke patients with dysphagia, study protocol of a double-blind randomized controlled trial. Trials. 2021 Jun 25;22(1):416. doi: 10.1186/s13063-021-05353-y.