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Inspiratory Muscle Training and Respiratory Electromyographic Activity in COPD

24 april 2017 bijgewerkt door: Diogo Fanfa Bordin, University of Santa Cruz do Sul

Effects of Inspiratory Muscle Training on Respiratory Electromyographic Activity in Patients With COPD Participants and Non-participants of a Pulmonary Rehabilitation Program

Intended to treat disorders of the respiratory muscles can use the device Threshold IMT ® through an inspiratory muscle training (IMT) that allows training of the inspiratory muscles, the chief of these being the diaphragm which is which objectified the improvement of its function . To monitor the action of the respiratory muscles can be used several tools such as manometer that aims to assess respiratory pressures, ie, the strength of respiratory muscles, or the Surface Electromyography (sEMG) that allow evaluating the electromyographic activity of muscles analyzed. From a quantitative clinical trial, randomized and blinded, composed of 45 individuals obtained by random convenience and divided into three groups, COPD participating in a pulmonary rehabilitation program (RP) which will make TMI (TGR - Trained Group Rehabilitated), COPD does not participant in a PR program (TGNR - Trained Group not Rehabilitated) and a control group composed of healthy individuals (CG) that seek to analyze the electromyographic activity of sternocleidomastoid (SCM) and diaphragm muscle strength, lung volumes and breathing patterns before and after a period of eight weeks of TMI. Manual will also be held dynamometry to compare the grip strength of the CG, TGR and TGNR only at baseline.

Hypothesis:

  1. The Inspiratory Muscle Training (IMT) increases the maximal inspiratory pressure (MIP) in COPD patients regardless of whether they are enrolled in a program of pulmonary rehabilitation (PR).
  2. TMI alters the breathing pattern in COPD patients regardless of whether they were entered into a PR program.
  3. Patients with COPD who do not participate in a PR program have higher handgrip strength compared to patients who did not participate in a PR program.
  4. There is decreased activity of the sternocleidomastoid muscle due to increased activity in the diaphragmatic muscle fibers after a period of TMI.
  5. TMI in COPD patients participating in a program RP produces greater increase in MIP, the handgrip strength, improves breathing pattern and a greater reduction in the activity of the SCM muscle and diaphragm than in those who did not participate in a program RP.
  6. There will be a reduction in respiratory rate, heart rate, systolic and diastolic blood pressure and increased oxygen saturation at the end of the TMI.
  7. TMI reduce the degree of dyspnea reported by patients as MRC scale at the end of the training period.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

20

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Brazilië
    • Rio Grande do Sul
      • Santa Cruz do Sul, Rio Grande do Sul, Brazilië
        • Universidade de Santa Cruz do Sul

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

40 jaar tot 80 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Will be included in the study subjects of both sexes aged between 40 and 80 years. For the control group will participate in healthy subjects, non-smokers with normal lung function. For Group TMI + Rehabilitation, Non-Rehabilitated and Rehabilitation Group participate COPD patients with GOLD staging II and III, participants and non-participants of a PR program respectively, where individuals not participating (GTMINR) will be those who will enter the PR program during the stipulated time of study and the participants have (GTMIR) should be included in the project for at least eight weeks, the time required for a program to provide RP's effects in COPD

Exclusion Criteria:

  • Not participate in the study and Group TMI + Rehabilitation, Non-Rehabilitated and Rehabilitation Group, individuals who do not fit the criteria for GOLD in stages II and III, which are in acute disease, presenting hemodynamic instability, aneurysm, cognitive impairment or any other co-morbidity that prevents this study. For the GC will not participate smokers, ex-smokers or who have compromised lung function, individuals participating in regular physical activity, ie three or more times per week, and no pathology that affects the cardiorespiratory system. Also excluded are those who do not sign the consent form.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Faculteitstoewijzing
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Group Pulmonary Rehabilitation
Pulmonary Rehabilitation consists of isotonic exercises of upper and lower limbs, 20-minute workout on cycle ergometer in standard desinsuflativo (expiration at the time of muscle contraction), is performed three times a week for eight weeks.
Ander: Pulmonary Rehabilitation
Pulmonary Rehabilitation consists of isotonic exercises of upper and lower limbs, 20-minute workout on cycle ergometer in standard deflation (expiration at the time of muscle contraction), is performed three times a week for eight weeks.
Experimenteel: Group TMI + Pulmonary Rehabilitation
Will be held inspiratory muscle training associated with a pulmonary rehabilitation program. The inspiratory muscle training is performed with a load of 40 to 50% of the muscle strength of the subjects. Pulmonary Rehabilitation consists of isotonic exercises of upper and lower limbs, 20-minute workout on cycle ergometer in standard deflation (expiration at the time of muscle contraction), is performed three times a week for eight weeks.
Ander: Pulmonary Rehabilitation
Pulmonary Rehabilitation consists of isotonic exercises of upper and lower limbs, 20-minute workout on cycle ergometer in standard deflation (expiration at the time of muscle contraction), is performed three times a week for eight weeks.
Ander: Inspiratory Muscle Training
Will be held inspiratory muscle training associated with a pulmonary rehabilitation program. The inspiratory muscle training is performed with a load of 40 to 50% of the muscle strength of the subjects.
Experimenteel: Control Group
Inspiratory muscle training will be held three times a week for eight weeks
Ander: Inspiratory Muscle Training
Will be held inspiratory muscle training associated with a pulmonary rehabilitation program. The inspiratory muscle training is performed with a load of 40 to 50% of the muscle strength of the subjects.
Experimenteel: COPD group not rehabilitation
Ander: Inspiratory Muscle Training
Will be held inspiratory muscle training associated with a pulmonary rehabilitation program. The inspiratory muscle training is performed with a load of 40 to 50% of the muscle strength of the subjects.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Muscle electromyographic activity of the accessory Inspiration
Tijdsspanne: The electromyographic activity will be evaluated during the inspiratory cycles for one minute, It will be evaluated over eight weeks
The electromyographic activity will be evaluated during the inspiratory cycles for one minute, It will be evaluated over eight weeks

Secundaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Inspiratory Muscle Training
Tijdsspanne: Will be performed with frequency of three days non-consecutive week, for eight weeks
Will be performed with frequency of three days non-consecutive week, for eight weeks
Assessment of lung volumes
Tijdsspanne: will be performed previously to the study and at the end, over eight weeks
will be performed previously to the study and at the end, over eight weeks
assessment of respiratory muscle strength
Tijdsspanne: will be performed previously to the study and at the end, as well as weekly to adjust the pressure load, It will be evaluated over eight weeks
will be performed previously to the study and at the end, as well as weekly to adjust the pressure load, It will be evaluated over eight weeks
breathing pattern assessment
Tijdsspanne: will be performed previously to the study and at the end of the same, It will be evaluated over eight weeks
will be performed previously to the study and at the end of the same, It will be evaluated over eight weeks

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Santa Cruz do Sul

Onderzoekers

  • Hoofdonderzoeker: Dulciane N Paiva, Doctor, University of Santa Cruz do Sul
  • Hoofdonderzoeker: Diogo F Bordin, Academic, University of Santa Cruz do Sul
  • Studie directeur: Dannuey M Cardoso, Master, University of Santa Cruz do Sul
  • Studie directeur: Andrea LG da Silva, Doctor, University of Santa Cruz do Sul

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 augustus 2013

Primaire voltooiing (Werkelijk)

1 november 2014

Studie voltooiing (Werkelijk)

1 januari 2015

Studieregistratiedata

Eerst ingediend

3 november 2013

Eerst ingediend dat voldeed aan de QC-criteria

11 december 2013

Eerst geplaatst (Schatting)

18 december 2013

Updates van studierecords

Laatste update geplaatst (Werkelijk)

25 april 2017

Laatste update ingediend die voldeed aan QC-criteria

24 april 2017

Laatst geverifieerd

1 april 2017

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • UNISC_001

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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