NCT03021252

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 13, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2020

Completed
Last Updated

September 22, 2020

Status Verified

September 1, 2019

Enrollment Period

2.9 years

First QC Date

January 10, 2017

Last Update Submit

September 18, 2020

Conditions

Swallowing DisorderStrokeRespiratory Muscle TrainingMalnutrition

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (3)

  • Change in tongue strength

    Baseline and weekly during 8 weeks

  • Change in fat-free mass

    Baseline, 3 months and 6 months post-stroke

  • Malnutrition at 6 months

    Baseline and 6 months post-stroke

Study Arms (2)

High intensity IEMT

EXPERIMENTAL

Inspiratory and expiratory muscle training + standard swallow therapy.

Device: High intensity IEMT

Sham IEMT

SHAM COMPARATOR

Sham inspiratory and expiratory muscle training + standard swallow therapy

Device: Sham IEMT

Interventions

High intensity IEMTDEVICE

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.

High intensity IEMT
Sham IEMTDEVICE

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

Sham IEMT

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Aphasia
  • History of cardiopulmonary disease; neurologic condition other than stroke and metabolic disease
  • Medical treatment with potential effect on muscle structure and function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital de l'Esperança

Barcelona, Catalonia, 08024, Spain

Location

Physical Medicine & Rehabilitation Dpt. Parc de Salut Mar.

Barcelona, 08024, Spain

Location

Related Publications (6)

  • 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.

    PMID: 16269630BACKGROUND

  • 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.

    PMID: 27271373BACKGROUND

  • 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.

    PMID: 26180145BACKGROUND

  • 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.

    PMID: 25503549BACKGROUND

  • 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.

    PMID: 22732970BACKGROUND

  • 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.

    PMID: 34172071DERIVED

MeSH Terms

Conditions

Deglutition DisordersStrokeMalnutrition

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Anna Guillén-Solà, MD, PhD

    Fundació IMIM - Parc de Salut Mar

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2017

First Posted

January 13, 2017

Study Start

March 1, 2017

Primary Completion

February 1, 2020

Study Completion

September 16, 2020

Last Updated

September 22, 2020

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

ES(2)