Acute Muscular and Vascular Responses to a Single Session of Exercise With BFR in COPD (2BFREE_aigu)
2026年6月25日 更新者：University Hospital, Grenoble
Blood Flow Restriction (BFR): a Novel Approach to Potentiate the Effects of Rehabilitative Exercise Training in COPD? Study of Acute - Muscular, and Vascular - Responses to a Single Session of Exercise With BFR
Exercise training is a cornerstone of pulmonary rehabilitation (PR) in patients with chronic obstructive pulmonary disease (COPD). However, some patients derive limited benefits from conventional exercise programs. Previous studies suggest that the magnitude of exercise-induced muscle fatigue is associated with training effectiveness, with patients unable to develop significant muscle fatigue ("non-fatiguers") showing smaller improvements in functional capacity and quality of life.
Blood flow restriction (BFR) exercise consists in performing physical exercise while applying external pressure to the proximal part of the exercising limb, thereby reducing oxygen delivery to the muscles and limiting metabolite clearance. This approach has been shown to induce significant muscular adaptations despite the use of low exercise intensities. Because exercise intensity in COPD patients is often constrained by ventilatory limitations, BFR training may enhance muscle adaptations while reducing respiratory stress, potentially improving the effectiveness of PR.
The primary objective of this monocentric randomized crossover study is to compare lower-limb muscle fatigue induced by a single exercise session performed with BFR versus a standard exercise session in patients with COPD.
調査の概要
状態
まだ募集していません
詳細な説明
Two exercise modalities commonly used in pulmonary rehabilitation will be investigated independently in two sub-studies: (1) resistance training performed with BFR or without BFR, and (2) aerobic endurance training performed with BFR or without BFR.
研究の種類
介入
入学 (推定)
40
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。
研究連絡先
- 名前：Mathieu Marillier, PhD
- 電話番号：+33681552231
- メール：mmarillier@chu-grenoble.fr
研究連絡先のバックアップ
- 名前：Bruno Degano, MD, PhD
- 電話番号：+33664810986
- メール：bdegano@chu-grenoble.fr
研究場所
-
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Auvergne-Rhône-Alpes
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La Tronche、Auvergne-Rhône-Alpes、フランス、38700
- CReSI - Laboratoire HP2
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コンタクト：
- Mathieu Marillier, PhD
- 電話番号：+33681552231
- メール：mmarillier@chu-grenoble.fr
-
コンタクト：
- Bruno Degano, MD, PhD
- 電話番号：+33664810986
- メール：bdegano@chu-grenoble.fr
-
-
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
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Negative pregnancy test and use of an acceptable contraceptive method throughout the study duration for women of childbearing potential
- Established COPD defined as obstructive ventilatory defect (FEV1/FVC < 0.70 or below the 5th percentile)
- Resting lung hyperinflation defined as functional residual capacity > 2.5 z-scores according to the Global Lung Function Initiative (GLI)
- Clinical stability of COPD for at least 3 months, with no recent exacerbation requiring treatment modification
- Covered by a national health insurance system
- Able and willing to provide written informed consent
Non-inclusion Criteria:
- Presence of a medical device incompatible with magnetic stimulation
- Inability to perform an exercise test on a cycle ergometer
Any usual contraindication to exercise testing, including:
- Recent myocardial infarction (3-5 days)
- Unstable coronary insufficiency
- Severe stenotic valvular disease
- Uncontrolled arrhythmia with hemodynamic instability
- Recent unexplained syncope
- Uncontrolled heart failure
- Uncontrolled arterial hypertension (systolic blood pressure ≥200 mmHg and/or diastolic blood pressure ≥110 mmHg at rest)
- Acute thromboembolic disease and/or pulmonary edema
Conditions contraindicating the use of blood flow restriction (BFR), including:
- Coagulation disorder
- Peripheral neuropathy
- Uncontrolled hypertension (>160/100 mmHg)
- Peripheral arterial disease
- History of venous thrombosis
- Intensive care unit stay within the last 3 months
- Participation in another study during an exclusion period
- Inability to be contacted in case of emergency
- Individuals covered under Articles L1121-5 to L1121-8 of the French Public Health Code (protected populations, including pregnant or breastfeeding women, prisoners, minors, individuals under legal protection, psychiatric inpatients, etc.)
- Staff members with a hierarchical relationship with the principal investigator
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：クロスオーバー割り当て
- 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：Blood flow restricted exercise session
Sub-study 1: resistance exercise session with Blood Flow Restriction (RE-BFR); Sub-study 2: aerobic endurance exercise session with Blood Flow Restriction (END-BFR).
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Sub-study 1 (RE-BFR): Resistance training consisting of 1 × 30 repetitions followed by 3 × 15 repetitions at 30% 1-RM, performed with thigh BFR to 50-60% of arterial occlusion pressure (AOP). Sub-study 2 (END-BFR): Low-intensity cycling exercise (~30% peak aerobic power) performed with thigh BFR to 50-60% of AOP. |
|
アクティブコンパレータ：Standard exercise session
Sub-study 1: resistance exercise session (RE); Sub-study 2: aerobic endurance exercise session (END).
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Sub-study 1 (RE): Resistance exercise consisting of 4 × 10 repetitions at 60-70% 1-RM. Sub-study 2 (END): Conventional aerobic endurance cycling exercise performed at ~50% peak aerobic power. |
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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Muscle fatigue
時間枠：Assessed 15-minutes before, and 3, 30, 60-minutes after exercise
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Muscle fatigue assessed by magnetic stimulation of the femoral nerve
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Assessed 15-minutes before, and 3, 30, 60-minutes after exercise
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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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Flow Mediated Dilation (FMD)
時間枠：30-minutes pre-exercise, and 10 and 75-minutes post-exercise
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Brachial artery FMD assessed by ultrasound
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30-minutes pre-exercise, and 10 and 75-minutes post-exercise
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Symptoms of dyspnea
時間枠：Assessed at the end of each exercise set/bout (sub-study 1) or every 2 minutes throughout exercise (sub-study 2)
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Modified Borg scale: ranging from 0 (nothing at all) to 10 (maximal)
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Assessed at the end of each exercise set/bout (sub-study 1) or every 2 minutes throughout exercise (sub-study 2)
|
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Affective valence
時間枠：Assessed at the end of each exercise set/bout (sub-study 1) or every 2 minutes throughout exercise (sub-study 2)
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Feeling scale: ranging from -5 (very bad) to 5 (very good)
|
Assessed at the end of each exercise set/bout (sub-study 1) or every 2 minutes throughout exercise (sub-study 2)
|
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Affective intensity
時間枠：Assessed at the end of each exercise set/bout (sub-study 1) or every 2 minutes throughout exercise (sub-study 2)
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Felt Arousal Scale: ranging from 1 (low activation state) to 6 (high activation state)
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Assessed at the end of each exercise set/bout (sub-study 1) or every 2 minutes throughout exercise (sub-study 2)
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Oxygen uptake
時間枠：Assessed at the end of each exercise set/bout (sub-study 1) or continuously throughout exercise (sub-study 2).
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Using metabolic chart, in L/min
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Assessed at the end of each exercise set/bout (sub-study 1) or continuously throughout exercise (sub-study 2).
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Carbon dioxide output
時間枠：Assessed at the end of each exercise set/bout (sub-study 1) or continuously throughout exercise (sub-study 2).
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Using metabolic chart, in L/min
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Assessed at the end of each exercise set/bout (sub-study 1) or continuously throughout exercise (sub-study 2).
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Minute ventilation
時間枠：Assessed at the end of each exercise set/bout (sub-study 1) or continuously throughout exercise (sub-study 2).
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Using metabolic chart, in L/min
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Assessed at the end of each exercise set/bout (sub-study 1) or continuously throughout exercise (sub-study 2).
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Breathing pattern
時間枠：Assessed at the end of each exercise set/bout (sub-study 1) or continuously throughout exercise (sub-study 2).
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Tidal volume (in L) and respiratory rate (in breaths per minute), using metabolic chart
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Assessed at the end of each exercise set/bout (sub-study 1) or continuously throughout exercise (sub-study 2).
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Heart rate
時間枠：Continuous monitoring throughout the exercise session.
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Using electrocardiogram, in beats/min
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Continuous monitoring throughout the exercise session.
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Blood pressure
時間枠：Continuous monitoring throughout the exercise session.
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Using digital cuff system, in mmHg
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Continuous monitoring throughout the exercise session.
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Cardiac output
時間枠：Continuous monitoring throughout the exercise session.
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Using impedance cardiography, in L/min
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Continuous monitoring throughout the exercise session.
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Leg discomfort
時間枠：Assessed at the end of each exercise set/bout (sub-study 1) or every 2 minutes throughout exercise (sub-study 2)
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Modified Borg scale: ranging from 0 (nothing at all) to 10 (maximal)
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Assessed at the end of each exercise set/bout (sub-study 1) or every 2 minutes throughout exercise (sub-study 2)
|
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。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Kilgas MA, Yoon T, McDaniel J, Phillips KC, Elmer SJ. Physiological Responses to Acute Cycling With Blood Flow Restriction. Front Physiol. 2022 Mar 11;13:800155. doi: 10.3389/fphys.2022.800155. eCollection 2022.
- Burtin C, Saey D, Saglam M, Langer D, Gosselink R, Janssens W, Decramer M, Maltais F, Troosters T. Effectiveness of exercise training in patients with COPD: the role of muscle fatigue. Eur Respir J. 2012 Aug;40(2):338-44. doi: 10.1183/09031936.00111811. Epub 2011 Dec 1.
- Spruit MA, Augustin IM, Vanfleteren LE, Janssen DJ, Gaffron S, Pennings HJ, Smeenk F, Pieters W, van den Bergh JJ, Michels AJ, Groenen MT, Rutten EP, Wouters EF, Franssen FM; CIRO+ Rehabilitation Network. Differential response to pulmonary rehabilitation in COPD: multidimensional profiling. Eur Respir J. 2015 Dec;46(6):1625-35. doi: 10.1183/13993003.00350-2015. Epub 2015 Oct 9.
- Mador MJ, Mogri M, Patel A. Contractile fatigue of the quadriceps muscle predicts improvement in exercise performance after pulmonary rehabilitation. J Cardiopulm Rehabil Prev. 2014 Jan-Feb;34(1):54-61. doi: 10.1097/HCR.0000000000000023.
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 (推定)
2026年11月1日
一次修了 (推定)
2028年12月1日
研究の完了 (推定)
2028年12月1日
試験登録日
最初に提出
2026年6月11日
QC基準を満たした最初の提出物
2026年6月19日
最初の投稿 (実際)
2026年6月25日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月30日
QC基準を満たした最後の更新が送信されました
2026年6月25日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- EssaiClinique_2BFREEaigu
- 2026-A00501-50 (レジストリ識別子：CPP Sud-Méditerranée I)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
The data that support the findings of this study will be made available from the contact person/backup upon reasonable request.
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米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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