Effects of Combined Cycle Training and Inspiratory Muscle Training in Patients With COPD
Effects of Combined Cycle Training and Inspiratory Muscle Training on Exercise Performance ,Health-related Quality,Dyspnoea ,Body Composition,Depressive Symptomatology in Patients With Chronic Obstructive Pulmonary Disease(COPD)
Chronic Obstructive Pulmonary Disease (COPD) ，the fourth leading cause of death in the world, represents an important public health challenge. It is also a major cause of chronic morbidity, mortality and disability throughout the world, leading to a heavy social and economic burden. For a long time, treatment of COPD mainly focus on drug therapy. Recently, pulmonary rehabilitation is recognized as a core component of the management of individuals with chronic respiratory disease, which has been clearly demonstrated to reduce dyspnea, increase exercise capacity, and improve quality of life.
Exercise training, widely regarded as the cornerstone of pulmonary rehabilitation , is one of the best available means of improving muscle function in COPD.The most commonly form is cycle training. Inspiratory Muscle Training (IMT) as an adjunct to exercise training has an additional benefit on inspiratory muscle strength, endurance and exercise capacity in patient with COPD.
There is insufficient evidence demonstrate greater benefits from combined inspiratory muscle training and cycle training. This study will evaluate the effects of combined inspiratory muscle training and cycle training in patients with COPD.
調査の概要
状態
詳細な説明
The patients with COPD will participate in a rehabilitation program for 8 weeks. Participants in the proposed study will be randomly programmed into one of three intervention groups:
- Cycle training program alone (performing on calibrated stationary cycle ergometer).
- Combined cycle training and inspiratory muscle training(performing on calibrated stationary cycle ergometer and threshold loading device).
- Neither cycle training nor inspiratory muscle training.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Guangdong
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Guangzhou、Guangdong、中国、510282
- Zhujiang Hospital,Southern Medical Universtiy
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
Patients between 40 and 75 years of age were eligible if they met the following criteria:
- moderate to severe airflow obstruction (30≤ Forced Expiratory Volume At One Second(FEV1) <80% predicted and Forced Expiratory Volume At One Second/Forced Vital Capacity(FEV1/FVC)<70%)
- Complaints of dyspnea on exertion
- Clinically stable condition
- No participation in a pulmonary rehabilitation program in the last year.
Exclusion Criteria:
- Patients were excluded if they had evidence of asthma and/or had experienced a major exacerbation in the 2 months before enrollment
- Required home oxygen therapy or experienced oxyhemoglobin desaturation below 85% with exercise
- And/or had other health problems that would interfere with exercise.
研究計画
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：並列代入
- マスキング：なし（オープンラベル）
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：対照群
サイクルトレーニングでも吸気筋トレーニングでもありません。
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サイクルトレーニングでも吸気筋トレーニングでもありません。
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実験的：Cycle training group
A 30-minute cycling training session is performed 3 days a week using calibrated cycle ergometer.
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The most common device to proform cycle training is calibrated cycle ergometer.
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実験的：Combined group
A 30-minute Combined training session is performed 3 days a week using calibrated cycle ergometer and threshold loading device.
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Combined cycle training and inspiratory muscle training.The threshold loading device is composed of a mouth -piece attached to a small plastic cylinder that contains a spring-loaded poppet value.
The valve opens to permit inspiratory flow only once the person has generated adequate negative intrathoracic pressure to condense the spring.
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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 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Exercise Performance (composite outcome measure)
時間枠：The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)
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Exercise performance tests include field walking tests and cycle ergometer tests.
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The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Health-related quality (composite outcome measure)
時間枠：The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)
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Health-related quality is a component of the broader concept of quality of life and is defined as satisfaction with health.The St. George's Respiratory Questionnaire (SGRQ) and Chronic Respiratory Disease Questionnaire (CRQ）; and its self-reported version are the most widely used disease-specific questionnaires.
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The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)
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inspiratory muscle function (composite outcome measure)
時間枠：The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)
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Currently, a variety of methods can be used to evaluate respiratory muscle function, including maximal inspiratory (PImax)，expiratory pressures(PEmax) and inspiratory muscle endurance.
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The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)
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Symptom Evaluation (composite outcome measure)
時間枠：The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)
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Individuals with chronic respiratory disease often have symptoms such as dyspnea, fatigue, cough, weakness, sleeplessness,and psychological distress.Instruments for assessment of multiple symptoms include COPD Assessment Test (CAT) and Modified Medical British Research Council Scale(mMRC).
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The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Depression and anxiety evaluation
時間枠：The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)
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Hospital Anxiety and Depression Scale (HADS) was found to perform well in assessing the symptom severity and caseness of anxiety disorders and depression in both somatic, psychiatric and primary care patients and in the general population.
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The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)
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Composite outcomes
時間枠：The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)
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Among patients with COPD there is increasing interest in the use of multidimensional indices to characterize the severity of the disease and better predict outcomes.Arguably the most well-known of these indices is the BODE Index.
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The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)
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Body Composition Monitor
時間枠：The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)
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Body composition abnormalities are prevalent in COPD.Human body composition analyzer can detect various elements of human body and analyze human health status.
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The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- CX13902205193
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