Acute Muscular and Vascular Responses to a Single Session of Exercise With BFR in COPD (2BFREE_aigu)
2026년 6월 25일 업데이트: 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.
연구 개요
상태
아직 모집하지 않음
상세 설명
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.
연구 유형
중재적
등록 (추정된)
40
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Mathieu Marillier, PhD
- 전화번호: +33681552231
- 이메일: mmarillier@chu-grenoble.fr
연구 연락처 백업
- 이름: Bruno Degano, MD, PhD
- 전화번호: +33664810986
- 이메일: bdegano@chu-grenoble.fr
연구 장소
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Auvergne-Rhône-Alpes
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La Tronche, Auvergne-Rhône-Alpes, 프랑스, 38700
- CReSI - Laboratoire HP2
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연락하다:
- Mathieu Marillier, PhD
- 전화번호: +33681552231
- 이메일: mmarillier@chu-grenoble.fr
-
연락하다:
- Bruno Degano, MD, PhD
- 전화번호: +33664810986
- 이메일: bdegano@chu-grenoble.fr
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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. |
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활성 비교기: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Muscle fatigue
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Flow Mediated Dilation (FMD)
기간: 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
기간: 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
기간: 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)
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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 intensity
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 11월 1일
기본 완료 (추정된)
2028년 12월 1일
연구 완료 (추정된)
2028년 12월 1일
연구 등록 날짜
최초 제출
2026년 6월 11일
QC 기준을 충족하는 최초 제출
2026년 6월 19일
처음 게시됨 (실제)
2026년 6월 25일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 30일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 25일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- EssaiClinique_2BFREEaigu
- 2026-A00501-50 (레지스트리 식별자: CPP Sud-Méditerranée I)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
The data that support the findings of this study will be made available from the contact person/backup upon reasonable request.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .