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Effects of Inspiratory Muscle Training on the Functional Gait Performance of Individuals After Stroke

3. april 2020 oppdatert av: Lorena de Oliveira Vaz Miranda

The most commonly observed sequel after stroke is muscle weakness, which can also be identified in respiratory muscles, in the acute and chronic phases, and may compromise the lung function of these individuals. Studies have shown that lower Pimax values are found in non-community ambulators, and gait velocity has been reported as an important indicator of functionality after stroke, with higher gait velocity values associated with greater community participation and better quality of life.

This study will test the hypothesis that training of the inspiratory muscles is effective in improving strength and endurance of the inspiratory muscles and functionality, including speed of gait, functional gait perfomarnce, activities of daily living and quality of life with stroke subjects.

For this clinical trial, people after stroke will be randomly allocated into either experimental or control/sham groups. The experimental group will undertake training of the inspiratory muscles with the Power Breath Medical Classic device regulated at 50% of the subjects' maximal inspiratory pressure values, five times/week over six weeks, twice a day for 15 minutes, totaling 30 minutes/day. The control group will undertake the same protocol, but the participants will receive the devices with a minimal load, wich corresponds to 1cmH2O. Both groups will participate in the rehabilitation program for 6 weeks. At baseline and post intervention, after the cessation of the interventions, researchers blinded to group allocations will collect the following outcome measures: maximal respiratory pressures, respiratory muscle endurance, functional gait performance, activities of daily living and quality of life. After 12 weeks will collect again maximal inspiratory pressures and functional gait performance.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

The most commonly observed sequel after stroke is muscle weakness, which can also be identified in respiratory muscles, in the acute and chronic phases, and may compromise the lung function of these individuals. Studies have shown that lower Pimax values are found in non-community ambulators, and gait velocity has been reported as an important indicator of functionality after stroke, with higher gait velocity values associated with greater community participation and better Quality of life.

Aim: This study will test the hypothesis that training of the inspiratory muscles is effective in improving strength and endurance of the inspiratory muscles and functional gait perfomarnce, activities of daily living and quality of life with stroke subjects.

Design: For this prospective, triple-blinded, randomized clinical trial, people after stroke will be randomly allocated into either experimental or control/sham groups. The experimental group will undertake training of the inspiratory muscles with the PowerBreath Medic Plus regulated at 50% of the subjects' maximal inspiratory pressure (MIP) values, five times/week over six weeks during 30 minutes/day. The control group will undertake the same protocol, but the participants will receive the threshold devices with minimal resistance valves. At baseline and post intervention after the cessation of the interventions, researchers blinded to group allocations will collect all outcome measures. After 12 weeks will collect again maximal inspiratory pressures and functional gait performance.

Study outcomes: Primary outcomes will be functional gait perfomarnce. Secondary outcomes will include inspiratory endurance, activities of daily living and quality of life.

Studietype

Intervensjonell

Registrering (Faktiske)

50

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Brasil
    • Bahia
      • Salvador, Bahia, Brasil
        • Lorena de Oliveira Vaz Miranda

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Adults with hemiparesis after stroke, of any etiology, ischemic or hemorrhagic, that carry out walking with or without assistance locomotion; Aged between 18 and 80 years of age; In the chronic period (between 6 months and 5 years); clinically stable (Measured through clinical and hemodynamic stability: vital signs within normal and released for physical activity by the physician), who present with inspiratory muscle weakness, defined as Pimáx less than -80cmH2O and score in the normal Mini Mental State Examination (MMSE) For schooling.

Exclusion Criteria:

  • Smokers and ex-smokers for more than five years, presence of facial paralysis that prevents lip occlusion, associated neurological diseases, orthopedic alterations that include distortions of the chest cavity or pains that prevent the tests from being performed, respiratory dysfunctions, cardiac dysfunctions that Compromise hemodynamic stability.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Eksperimentell gruppe
Annen: Inspiratory Muscle Training

Experimental: IMT will include training of the inspiratory muscles five times per week over six weeks, divided into two fiftten-minute sessions of inspiratory training totaling 30 minutes of training. Thresholds regulated at 50% of the subjects' maximal inspiratory pressure values, the load being increased weekly. Associated with the IMT, subjects will participate in the rehabilitation program, when they will perform 7 sessions of physiotherapy per week, totaling 42 sessions, as well as 180 minutes per week of aerobic exercise, for six weeks.

Sham Group: This group will underwent exactly the same protocol but the participants will receive the threshold devices with the minimum resistance of the spring, which will be also concealed. The control group will also participate in the rehabilitation program and undergo the same procedures, except for the load adjustments.
Sham-komparator: Kontrollgruppe
Annen: Inspiratory Muscle Training

Experimental: IMT will include training of the inspiratory muscles five times per week over six weeks, divided into two fiftten-minute sessions of inspiratory training totaling 30 minutes of training. Thresholds regulated at 50% of the subjects' maximal inspiratory pressure values, the load being increased weekly. Associated with the IMT, subjects will participate in the rehabilitation program, when they will perform 7 sessions of physiotherapy per week, totaling 42 sessions, as well as 180 minutes per week of aerobic exercise, for six weeks.

Sham Group: This group will underwent exactly the same protocol but the participants will receive the threshold devices with the minimum resistance of the spring, which will be also concealed. The control group will also participate in the rehabilitation program and undergo the same procedures, except for the load adjustments.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
change in functional gait perfomarnce
Tidsramme: change from Baseline at 6 weeks
functional gait perfomarnce will be assessed by six minute walk test. (6MWT)
change from Baseline at 6 weeks

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
endurance muscular respiratory
Tidsramme: Baseline and after 6 weeks
inspiratory and expiratory endurance will be assessed by the threshold devices, following previously described protocols.
Baseline and after 6 weeks
maximal respiratory pressures
Tidsramme: Baseline, after 6 six weeks and three-monsth follow-ups
Maximal respiratory pressures will be assessed by a analogic manovacuometer, following previously described protocols.
Baseline, after 6 six weeks and three-monsth follow-ups
functional gait perfomarnce
Tidsramme: three-monsth follow-ups
functional gait perfomarnce will be assessed by six minute walk test. (6MWT)
three-monsth follow-ups
activities of daily living
Tidsramme: Baseline and after 6 weeks
activities of daily living: will be assessed by measure independence functional (MIF)
Baseline and after 6 weeks
Quality of life
Tidsramme: Baseline, after 6 weeks and three-monsth follow-ups
Quality of life will be assessed by the Brazilian version of the EQ5D.
Baseline, after 6 weeks and three-monsth follow-ups

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Lorena de Oliveira Vaz Miranda

Etterforskere

  • Studieleder: Jamary Oliveira Filho, Federal University of Bahia

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. juni 2017

Primær fullføring (Faktiske)

30. mars 2019

Studiet fullført (Faktiske)

30. mars 2019

Datoer for studieregistrering

Først innsendt

25. mai 2017

Først innsendt som oppfylte QC-kriteriene

26. mai 2017

Først lagt ut (Faktiske)

31. mai 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

6. april 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. april 2020

Sist bekreftet

1. april 2020

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 65028517.0.0000.0022

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

The data collected in this study will be made available on this basis and will be published in a scientific journal. A master's dissertation will also be built. Further said reports will be provided to the ethics committee while conducting the study.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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