Control Condition2BFREE_aiguNCT07668921
Acute Muscular and Vascular Responses to a Single Session of Exercise With BFR in COPD
A study testing Blood Flow Restriction and Standard exercise session in people with Control Condition and Pulmonary Disease (COPD), Chronic Obstructive, run by University Hospital, Grenoble at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Control Condition, Pulmonary Disease (COPD), Chronic Obstructive, Blood Flow Restriction Training (BFRT)
- What is being tested?
- Blood Flow Restriction and Standard exercise session
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 29Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
CReSI - Laboratoire HP2
La Tronche, Auvergne-Rhône-Alpes, 38700
Bruno Degano, MD, PhD, +33664810986, bdegano@chu-grenoble.fr
Mathieu Marillier, PhD, +33681552231, mmarillier@chu-grenoble.fr
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Control Condition, Pulmonary Disease (COPD), Chronic Obstructive, Blood Flow Restriction Training (BFRT)
- Being tested
- Blood Flow Restriction, Standard exercise session
- Keywords
- Muscle Fatigue, COPD, Aerobic exercise, Resistance exercise, Blood Flow Restriction Training
- Medical subject headings
- Lung Diseases, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Flow RestrictionDevice
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 sessionDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Blood flow restricted exercise session | Experimental | 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). Receives: Device: Blood Flow Restriction |
| Standard exercise session | Active comparator | Sub-study 1: resistance exercise session (RE); Sub-study 2: aerobic endurance exercise session (END). Receives: Device: Standard exercise session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle fatigue
Muscle fatigue assessed by magnetic stimulation of the femoral nerve
Measured: Assessed 15-minutes before, and 3, 30, 60-minutes after exercise
Secondary outcomes (12)
Flow Mediated Dilation (FMD)
Brachial artery FMD assessed by ultrasound
Measured: 30-minutes pre-exercise, and 10 and 75-minutes post-exercise
Symptoms of dyspnea
Modified Borg scale: ranging from 0 (nothing at all) to 10 (maximal)
Measured: Assessed at the end of each exercise set/bout (sub-study 1) or every 2 minutes throughout exercise (sub-study 2)
Leg discomfort
Modified Borg scale: ranging from 0 (nothing at all) to 10 (maximal)
Measured: Assessed at the end of each exercise set/bout (sub-study 1) or every 2 minutes throughout exercise (sub-study 2)
Affective valence
Feeling scale: ranging from -5 (very bad) to 5 (very good)
Measured: Assessed at the end of each exercise set/bout (sub-study 1) or every 2 minutes throughout exercise (sub-study 2)
Affective intensity
Felt Arousal Scale: ranging from 1 (low activation state) to 6 (high activation state)
Measured: Assessed at the end of each exercise set/bout (sub-study 1) or every 2 minutes throughout exercise (sub-study 2)
Oxygen uptake
Using metabolic chart, in L/min
Measured: Assessed at the end of each exercise set/bout (sub-study 1) or continuously throughout exercise (sub-study 2).
Carbon dioxide output
Using metabolic chart, in L/min
Measured: Assessed at the end of each exercise set/bout (sub-study 1) or continuously throughout exercise (sub-study 2).
Minute ventilation
Using metabolic chart, in L/min
Measured: Assessed at the end of each exercise set/bout (sub-study 1) or continuously throughout exercise (sub-study 2).
Breathing pattern
Tidal volume (in L) and respiratory rate (in breaths per minute), using metabolic chart
Measured: Assessed at the end of each exercise set/bout (sub-study 1) or continuously throughout exercise (sub-study 2).
Heart rate
Using electrocardiogram, in beats/min
Measured: Continuous monitoring throughout the exercise session.
Blood pressure
Using digital cuff system, in mmHg
Measured: Continuous monitoring throughout the exercise session.
Cardiac output
Using impedance cardiography, in L/min
Measured: Continuous monitoring throughout the exercise session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study startNov 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Control ConditionStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07668921
- Sponsor's protocol ID
- EssaiClinique_2BFREEaigu
- Other IDs
- 2026-A00501-50
- Acronym
- 2BFREE_aigu
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data that support the findings of this study will be made available from the contact person/backup upon reasonable request.
Publications
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.
PubMed 35360241Burtin 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.
PubMed 22135284Spruit 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.
PubMed 26453626Mador 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.
PubMed 24165798
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07668921
- Acronym / sponsor ID
- 2BFREE_aigu / EssaiClinique_2BFREEaigu
- Conditions
- Control Condition, Pulmonary Disease (COPD), Chronic Obstructive, Blood Flow Restriction Training (BFRT)
- Keywords
- Muscle Fatigue, COPD, Aerobic exercise, Resistance exercise, Blood Flow Restriction Training
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 25 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blood flow restricted exercise session | Experimental | Device: Blood Flow RestrictionSub-study 1: resistance exercise session with Blood Flow Restriction (RE-BFR); Sub-study 2: aerobic endurance exercise session with Blood Flow Restriction (END-BFR). |
| Standard exercise session | Active comparator | Device: Standard exercise sessionSub-study 1: resistance exercise session (RE); Sub-study 2: aerobic endurance exercise session (END). |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Flow RestrictionSub-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. | Device | Blood flow restricted exercise session |
| Standard exercise sessionSub-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. | Device | Standard exercise session |
Primary outcome
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
12 secondary outcomes
Flow Mediated Dilation (FMD)
Time frame: 30-minutes pre-exercise, and 10 and 75-minutes post-exercise
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)
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)
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)
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)
Oxygen uptake
Time frame: Assessed at the end of each exercise set/bout (sub-study 1) or continuously throughout exercise (sub-study 2).
Carbon dioxide output
Time frame: Assessed at the end of each exercise set/bout (sub-study 1) or continuously throughout exercise (sub-study 2).
Minute ventilation
Time frame: Assessed at the end of each exercise set/bout (sub-study 1) or continuously throughout exercise (sub-study 2).
Breathing pattern
Time frame: Assessed at the end of each exercise set/bout (sub-study 1) or continuously throughout exercise (sub-study 2).
Heart rate
Time frame: Continuous monitoring throughout the exercise session.
Blood pressure
Time frame: Continuous monitoring throughout the exercise session.
Cardiac output
Time frame: Continuous monitoring throughout the exercise session.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Background: PubMed 35360241Kilgas 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.
- Background: PubMed 22135284Burtin 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.
- Background: PubMed 26453626Spruit 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.
- Background: PubMed 24165798Mador 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.
- Individual participant dataSharing planned: Yes. The data that support the findings of this study will be made available from the contact person/backup upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Flow Restriction and Standard exercise session in people with Control Condition and Pulmonary Disease (COPD), Chronic Obstructive, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 29 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bruno Degano, MD, PhD (+33664810986, bdegano@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle fatigue (time frame: Assessed 15-minutes before, and 3, 30, 60-minutes after exercise). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07668921, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.