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

25. juni 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

40

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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Studiekontakt

Studer Kontakt Backup

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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).
Enhet: 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.
Aktiv komparator: Standard exercise session
Sub-study 1: resistance exercise session (RE); Sub-study 2: aerobic endurance exercise session (END).
Enhet: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Muscle fatigue
Tidsramme: 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

Sekundære resultatmål

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

Samarbeidspartnere og etterforskere

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Sponsor

University Hospital, Grenoble

Publikasjoner og nyttige lenker

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Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. november 2026

Primær fullføring (Antatt)

1. desember 2028

Studiet fullført (Antatt)

1. desember 2028

Datoer for studieregistrering

Først innsendt

11. juni 2026

Først innsendt som oppfylte QC-kriteriene

19. juni 2026

Først lagt ut (Faktiske)

25. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

30. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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