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Acute Muscular and Vascular Responses to a Single Session of Exercise With BFR in COPD (2BFREE_aigu)

25 juin 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

40

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

  • France
    • Auvergne-Rhône-Alpes
      • La Tronche, Auvergne-Rhône-Alpes, France, 38700

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation croisée
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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).
Dispositif: Blood Flow Restriction

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.
Comparateur actif: Standard exercise session
Sub-study 1: resistance exercise session (RE); Sub-study 2: aerobic endurance exercise session (END).
Dispositif: Standard exercise session

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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Muscle fatigue
Délai: Assessed 15-minutes before, and 3, 30, 60-minutes after exercise
Muscle fatigue assessed by magnetic stimulation of the femoral nerve
Assessed 15-minutes before, and 3, 30, 60-minutes after exercise

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Flow Mediated Dilation (FMD)
Délai: 30-minutes pre-exercise, and 10 and 75-minutes post-exercise
Brachial artery FMD assessed by ultrasound
30-minutes pre-exercise, and 10 and 75-minutes post-exercise
Symptoms of dyspnea
Délai: Assessed at the end of each exercise set/bout (sub-study 1) or every 2 minutes throughout exercise (sub-study 2)
Modified Borg scale: ranging from 0 (nothing at all) to 10 (maximal)
Assessed at the end of each exercise set/bout (sub-study 1) or every 2 minutes throughout exercise (sub-study 2)
Affective valence
Délai: Assessed at the end of each exercise set/bout (sub-study 1) or every 2 minutes throughout exercise (sub-study 2)
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)
Affective intensity
Délai: Assessed at the end of each exercise set/bout (sub-study 1) or every 2 minutes throughout exercise (sub-study 2)
Felt Arousal Scale: ranging from 1 (low activation state) to 6 (high activation state)
Assessed at the end of each exercise set/bout (sub-study 1) or every 2 minutes throughout exercise (sub-study 2)
Oxygen uptake
Délai: Assessed at the end of each exercise set/bout (sub-study 1) or continuously throughout exercise (sub-study 2).
Using metabolic chart, in L/min
Assessed at the end of each exercise set/bout (sub-study 1) or continuously throughout exercise (sub-study 2).
Carbon dioxide output
Délai: Assessed at the end of each exercise set/bout (sub-study 1) or continuously throughout exercise (sub-study 2).
Using metabolic chart, in L/min
Assessed at the end of each exercise set/bout (sub-study 1) or continuously throughout exercise (sub-study 2).
Minute ventilation
Délai: Assessed at the end of each exercise set/bout (sub-study 1) or continuously throughout exercise (sub-study 2).
Using metabolic chart, in L/min
Assessed at the end of each exercise set/bout (sub-study 1) or continuously throughout exercise (sub-study 2).
Breathing pattern
Délai: Assessed at the end of each exercise set/bout (sub-study 1) or continuously throughout exercise (sub-study 2).
Tidal volume (in L) and respiratory rate (in breaths per minute), using metabolic chart
Assessed at the end of each exercise set/bout (sub-study 1) or continuously throughout exercise (sub-study 2).
Heart rate
Délai: Continuous monitoring throughout the exercise session.
Using electrocardiogram, in beats/min
Continuous monitoring throughout the exercise session.
Blood pressure
Délai: Continuous monitoring throughout the exercise session.
Using digital cuff system, in mmHg
Continuous monitoring throughout the exercise session.
Cardiac output
Délai: Continuous monitoring throughout the exercise session.
Using impedance cardiography, in L/min
Continuous monitoring throughout the exercise session.
Leg discomfort
Délai: Assessed at the end of each exercise set/bout (sub-study 1) or every 2 minutes throughout exercise (sub-study 2)
Modified Borg scale: ranging from 0 (nothing at all) to 10 (maximal)
Assessed at the end of each exercise set/bout (sub-study 1) or every 2 minutes throughout exercise (sub-study 2)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University Hospital, Grenoble

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 novembre 2026

Achèvement primaire (Estimé)

1 décembre 2028

Achèvement de l'étude (Estimé)

1 décembre 2028

Dates d'inscription aux études

Première soumission

11 juin 2026

Première soumission répondant aux critères de contrôle qualité

19 juin 2026

Première publication (Réel)

25 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

30 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

25 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • EssaiClinique_2BFREEaigu
  • 2026-A00501-50 (Identificateur de registre: CPP Sud-Méditerranée I)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

The data that support the findings of this study will be made available from the contact person/backup upon reasonable request.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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