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Swallowing DisorderRETORNUS-2NCT03021252

Respiratory Muscle Training in Stroke Swallowing Disorders

A study testing High intensity IEMT in people with Swallowing Disorder and Stroke, run by Parc de Salut Mar at 2 sites in Spain.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
High intensity IEMT
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
2 sitesSpain
Study dates
1 Mar 2017to 16 Sep 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Spain2 sites

  • Hospital de l'Esperança

    Barcelona, Catalonia, 08024

  • Physical Medicine & Rehabilitation Dpt. Parc de Salut Mar.

    Barcelona, 08024

Other trials in Spain

About this study

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

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.

Read the 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.

Being tested
High intensity IEMT, Sham IEMT
Medical subject headings
Deglutition Disorders, Stroke, Malnutrition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • Sham IEMTDevice

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

Study groups in NCT03021252
Study groupRoleWhat they receive
High intensity IEMTExperimentalInspiratory and expiratory muscle training + standard swallow therapy.
Receives: Device: High intensity IEMT
Sham IEMTSham comparatorSham inspiratory and expiratory muscle training + standard swallow therapy
Receives: Device: Sham IEMT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Baseline and weekly during 8 weeks

  2. 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.

    Measured: Baseline, 8 weeks, 6 months post-stroke

Secondary outcomes (3)

  1. Change in tongue strength

    Lingual Force (IOPI system): maximum isometric tongue pressure defined as the highest of the three peak isometric tongue pressure scores.

    Measured: Baseline and weekly during 8 weeks

  2. 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

    Measured: Baseline, 3 months and 6 months post-stroke

  3. Malnutrition at 6 months

    Malnutrition criteria of the European Society of Clinical Nutrition and Metabolism (ESPEN)

    Measured: Baseline and 6 months post-stroke

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2017 (estimated)
  2. Study start1 Mar 2017
  3. Primary completion1 Feb 2020
  4. Study completion16 Sep 2020

Why it stopped: Because of the SARS-COV2 pandemic. Recruitment stopped at 48 patients

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03021252
Sponsor's protocol ID
PSM/RHB/NR21
Acronym
RETORNUS-2
Status last verified
Sep 2019
First submitted
10 Jan 2017
Last updated
22 Sep 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 16269630

  • 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.

    PubMed 27271373

  • 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.

    PubMed 26180145

  • 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.

    PubMed 25503549

  • 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.

    PubMed 22732970

  • 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.

    PubMed 34172071

Questions about this trial

What is this clinical trial studying?

A study testing High intensity IEMT in people with Swallowing Disorder and Stroke, run by Parc de Salut Mar at 2 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 22 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Because of the SARS-COV2 pandemic. Recruitment stopped at 48 patients). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in respiratory muscle strength (time frame: Baseline and weekly during 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03021252, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2020.

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