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Inspiratory Muscle Training and Respiratory Electromyographic Activity in COPD

24. April 2017 aktualisiert von: 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.

Studienübersicht

Studientyp

Interventionell

Einschreibung (Tatsächlich)

20

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

40 Jahre bis 80 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Fakultätszuweisung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
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.
Experimental: 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.
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.
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.
Experimental: Control Group
Inspiratory muscle training will be held three times a week for eight weeks
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.
Experimental: COPD group not 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
Muscle electromyographic activity of the accessory Inspiration
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
Inspiratory Muscle Training
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. August 2013

Primärer Abschluss (Tatsächlich)

1. November 2014

Studienabschluss (Tatsächlich)

1. Januar 2015

Studienanmeldedaten

Zuerst eingereicht

3. November 2013

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

11. Dezember 2013

Zuerst gepostet (Schätzen)

18. Dezember 2013

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

25. April 2017

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

24. April 2017

Zuletzt verifiziert

1. April 2017

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • UNISC_001

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