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NCT Number: NCT07668921

Acute Muscular and Vascular Responses to a Single Session of Exercise With BFR in COPD

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.

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Key information

Conditions

Control Condition Blood Flow Restriction Training (BFRT) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease (COPD), Chronic Obstructive Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood Flow Restriction

Device

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.

Standard exercise session

Device

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.

Primary outcomes

  1. Muscle fatigue

    Time frame: Assessed 15-minutes before, and 3, 30, 60-minutes after exercise

    Muscle fatigue assessed by magnetic stimulation of the femoral nerve

Secondary outcomes

  1. Flow Mediated Dilation (FMD)

    Time frame: 30-minutes pre-exercise, and 10 and 75-minutes post-exercise

    Brachial artery FMD assessed by ultrasound

  2. Symptoms of dyspnea

    Time frame: 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)

  3. Leg discomfort

    Time frame: 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)

  4. Affective valence

    Time frame: 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)

  5. Affective intensity

    Time frame: 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)

  6. Oxygen uptake

    Time frame: 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

  7. Carbon dioxide output

    Time frame: 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

  8. Minute ventilation

    Time frame: 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

  9. Breathing pattern

    Time frame: 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

  10. Heart rate

    Time frame: Continuous monitoring throughout the exercise session.

    Using electrocardiogram, in beats/min

  11. Blood pressure

    Time frame: Continuous monitoring throughout the exercise session.

    Using digital cuff system, in mmHg

  12. Cardiac output

    Time frame: Continuous monitoring throughout the exercise session.

    Using impedance cardiography, in L/min

Study contacts

Contact information is provided by the study sponsor or research team.

Bruno Degano, MD, PhD

CONTACT

[email protected]

+33664810986

Mathieu Marillier, PhD

CONTACT

[email protected]

+33681552231

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

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

Acronym: 2BFREE_aigu

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 25, 2026
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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