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

25. Juni 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

40

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Crossover-Aufgabe
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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).
Gerät: 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.
Aktiver Komparator: Standard exercise session
Sub-study 1: resistance exercise session (RE); Sub-study 2: aerobic endurance exercise session (END).
Gerät: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Muscle fatigue
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Flow Mediated Dilation (FMD)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Continuous monitoring throughout the exercise session.
Using electrocardiogram, in beats/min
Continuous monitoring throughout the exercise session.
Blood pressure
Zeitfenster: Continuous monitoring throughout the exercise session.
Using digital cuff system, in mmHg
Continuous monitoring throughout the exercise session.
Cardiac output
Zeitfenster: Continuous monitoring throughout the exercise session.
Using impedance cardiography, in L/min
Continuous monitoring throughout the exercise session.
Leg discomfort
Zeitfenster: 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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University Hospital, Grenoble

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. November 2026

Primärer Abschluss (Geschätzt)

1. Dezember 2028

Studienabschluss (Geschätzt)

1. Dezember 2028

Studienanmeldedaten

Zuerst eingereicht

11. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

19. Juni 2026

Zuerst gepostet (Tatsächlich)

25. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

30. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

25. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • EssaiClinique_2BFREEaigu
  • 2026-A00501-50 (Registrierungskennung: CPP Sud-Méditerranée I)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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