Inspiratory Muscle Training and Respiratory Electromyographic Activity in COPD
2017年4月24日 更新者：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.
調査の概要
研究の種類
介入
入学 (実際)
20
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Rio Grande do Sul
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Santa Cruz do Sul、Rio Grande do Sul、ブラジル
- Universidade de Santa Cruz do Sul
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
40年～80年 (大人、高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：階乗代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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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実験的：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.
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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.
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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実験的：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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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
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Muscle electromyographic activity of the accessory Inspiration
時間枠：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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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Inspiratory Muscle Training
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Dulciane N Paiva, Doctor、University of Santa Cruz do Sul
- 主任研究者：Diogo F Bordin, Academic、University of Santa Cruz do Sul
- スタディディレクター：Dannuey M Cardoso, Master、University of Santa Cruz do Sul
- スタディディレクター：Andrea LG da Silva, Doctor、University of Santa Cruz do Sul
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2013年8月1日
一次修了 (実際)
2014年11月1日
研究の完了 (実際)
2015年1月1日
試験登録日
最初に提出
2013年11月3日
QC基準を満たした最初の提出物
2013年12月11日
最初の投稿 (見積もり)
2013年12月18日
学習記録の更新
投稿された最後の更新 (実際)
2017年4月25日
QC基準を満たした最後の更新が送信されました
2017年4月24日
最終確認日
2017年4月1日
詳しくは
本研究に関する用語
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Pulmonary Rehabilitationの臨床試験
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Bahçeşehir UniversityNevsehir Haci Bektas Veli Universityまだ募集していません