Inspiratory Muscle Training and Respiratory Electromyographic Activity in COPD
24 avril 2017 mis à jour par: 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:
- 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).
- TMI alters the breathing pattern in COPD patients regardless of whether they were entered into a PR program.
- 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.
- There is decreased activity of the sternocleidomastoid muscle due to increased activity in the diaphragmatic muscle fibers after a period of TMI.
- 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.
- 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.
- TMI reduce the degree of dyspnea reported by patients as MRC scale at the end of the training period.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
20
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Rio Grande do Sul
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Santa Cruz do Sul, Rio Grande do Sul, Brésil
- Universidade de Santa Cruz do Sul
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
40 ans à 80 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation factorielle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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.
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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.
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Expérimental: 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.
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Expérimental: Control Group
Inspiratory muscle training will be held three times a week for eight weeks
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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.
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Expérimental: COPD group not rehabilitation
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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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Muscle electromyographic activity of the accessory Inspiration
Délai: The electromyographic activity will be evaluated during the inspiratory cycles for one minute, It will be evaluated over eight weeks
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The electromyographic activity will be evaluated during the inspiratory cycles for one minute, It will be evaluated over eight weeks
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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Inspiratory Muscle Training
Délai: Will be performed with frequency of three days non-consecutive week, for eight weeks
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Will be performed with frequency of three days non-consecutive week, for eight weeks
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Assessment of lung volumes
Délai: will be performed previously to the study and at the end, over eight weeks
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will be performed previously to the study and at the end, over eight weeks
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assessment of respiratory muscle strength
Délai: 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
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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
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breathing pattern assessment
Délai: will be performed previously to the study and at the end of the same, It will be evaluated over eight weeks
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will be performed previously to the study and at the end of the same, It will be evaluated over eight weeks
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Dulciane N Paiva, Doctor, University of Santa Cruz do Sul
- Chercheur principal: Diogo F Bordin, Academic, University of Santa Cruz do Sul
- Directeur d'études: Dannuey M Cardoso, Master, University of Santa Cruz do Sul
- Directeur d'études: Andrea LG da Silva, Doctor, University of Santa Cruz do Sul
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 août 2013
Achèvement primaire (Réel)
1 novembre 2014
Achèvement de l'étude (Réel)
1 janvier 2015
Dates d'inscription aux études
Première soumission
3 novembre 2013
Première soumission répondant aux critères de contrôle qualité
11 décembre 2013
Première publication (Estimation)
18 décembre 2013
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
25 avril 2017
Dernière mise à jour soumise répondant aux critères de contrôle qualité
24 avril 2017
Dernière vérification
1 avril 2017
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- UNISC_001
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .