Exacerbation and Training in Patients With Chronic Obstructive Pulmonary Disease (EXTRA)
Exacerbation and Training - Study; a Randomized Controlled Study of the Effect of Resistance Training in Acute Exacerbations of COPD
When patients with chronic obstructive lung disease (COPD) are admitted to the hospital with a severe exacerbation they lose muscle strength. This muscle weakness predisposes these patients to further hospital admissions. Resistance training is a potent countermeasure to prevent and treat muscle weakness. In the setting of an acute exacerbation this intervention however has not been validated.
The present study aims at investigating the safety and efficacy of resistance training (3x8 quadriceps extensions per day) to prevent muscle weakness. End points are quadriceps muscle strength and hospital readmission and functional status at discharge. Using the minimally invasive needle muscle biopsy technique described by Bergström the effects of resistance training on the skeletal muscle will be analyzed in detail.
After giving informed consent, patients will be randomized on admission into usual care or usual care plus resistance training. Patients will be followed-up using the clinical pathway for COPD (10 days). After one month patients will attend the outpatient clinic for a follow-up visit. Besides the measurement prescribed in the clinical path for COPD (including arterial blood gas measures, lung function, functional investigation of the patients), patients will undergo muscle strength measures and venous blood will be drawn for the analysis of systemic inflammatory and growth factors. Half of the patients will receive a resistance training program. At the end of the hospital admission, a needle biopsy of the vastus lateralis muscle will be obtained.
調査の概要
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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Leuven、ベルギー、3000
- Universitair Ziekenhuis Leuven, Campus Gasthuisberg
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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:
- COPD exacerbation, admitted to the respiratory units
- Informed consent
- Age < 80
- No critical comorbidity compromising outcome up to one month.
- No suspect of malignancy
Exclusion criteria:
- Patient is involved in a rehabilitation program with a frequency >1/wk during one month after inclusion in the study
- NIMV or ICU on admission
- Patient scheduled for procedure (LTX/LVRS) within one month after discharge
- Readmission <14 days after previous hospitalization
- Significant pathology that would hinder the participation in resistance training (gonarthrosis, arthritis to be judged by the investigator)
- Clinical signs of pulmonary hypertension
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: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:1
Resistance training: series of 3x8 repetitions will be performed for the quadriceps muscle at 70% of the 1 Repetition Maximum determined as the weight the patient can lift once over the full range of motion.
The weight can be applied using free weights or using a classical multi-gym device or a quadriceps chair.
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Resistance training: series of 3x8 repetitions will be performed for the quadriceps muscle at 70% of the 1 Repetition Maximum determined as the weight the patient can lift once over the full range of motion.
The weight can be applied using free weights or using a classical multi-gym device or a quadriceps chair.
他の名前:
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プラセボコンパレーター:2
Usual care according to clinical pathway for COPD exacerbations + NO training
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usual care according to clinical pathway for COPD, No training
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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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Reduction in the decline of muscle force during the exacerbation.
時間枠:discharge Day 9
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discharge Day 9
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二次結果の測定
結果測定 |
時間枠 |
---|---|
Time to readmission or death
時間枠:6 Months
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6 Months
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Functional exercise capacity at discharge (6MWT)
時間枠:discharge Day 9
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discharge Day 9
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Functional exercise capacity and muscle force at 1 month
時間枠:1 Month
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1 Month
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Markers of systemic inflammation and oxidative stress in serum and muscle of patients at day 9 of the exacerbation.
時間枠:Day 9
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Day 9
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協力者と研究者
スポンサー
出版物と役立つリンク
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 (見積もり)
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
- 1.5.139.06KAN
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。
COPDの臨床試験
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Istituto Nazionale di Ricovero e Cura per Anziani募集
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Bio-Sensing Solutions S.L. (DyCare)Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau; Centre de Validació...募集
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University Hospital, Brest募集
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The First Affiliated Hospital of Guangzhou Medical...募集
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Association des Réseaux BronchioliteLaboratoire Système et Matériaux pour la Mécatronique (SYMME)募集
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Baylor Research Instituteまだ募集していません
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Polytechnic Institute of PortoNippon Gases Portugal募集
Resistance trainingの臨床試験
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University of MinnesotaNational Institute of Mental Health (NIMH)募集精神病性障害 | 統合失調症 | 統合失調症スペクトラムおよびその他の精神病性障害 | 統合失調感情障害 | 精神病 | 統合失調感情障害 | 統合失調症性障害 | 精神病、感情的 | 精神性気分障害 | 精神病患者番号/その他アメリカ
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VA Office of Research and Development募集
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University of WashingtonNational Institute on Aging (NIA); Kaiser Permanente完了
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Universidade Metodista de Piracicaba完了アスレチックパフォーマンス | アスリート | 呼吸筋 | 呼吸法 | 有酸素容量
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Queens College, The City University of New York完了
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Diakonhjemmet HospitalThe Dam Foundation; The Norwegian Council for Musculoskeletal Health募集