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| ID | Type | Description | Link |
|---|---|---|---|
| 2026-A00501-50 | Registry Identifier | CPP Sud-Méditerranée I |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| Standard exercise session | Active Comparator | Sub-study 1: resistance exercise session (RE); Sub-study 2: aerobic endurance exercise session (END). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Muscle fatigue | Muscle fatigue assessed by magnetic stimulation of the femoral nerve | Assessed 15-minutes before, and 3, 30, 60-minutes after exercise |
| Measure | Description | Time Frame |
|---|---|---|
| Flow Mediated Dilation (FMD) | Brachial artery FMD assessed by ultrasound | 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) |
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Inclusion Criteria:
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:
Conditions contraindicating the use of blood flow restriction (BFR), including:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bruno Degano, MD, PhD | Contact | +33664810986 | bdegano@chu-grenoble.fr | |
| Mathieu Marillier, PhD | Contact | +33681552231 | mmarillier@chu-grenoble.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CReSI - Laboratoire HP2 | La Tronche | Auvergne-Rhône-Alpes | 38700 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35360241 | Background | 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. | |
| 22135284 | Background | Burtin 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. |
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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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| 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. |
|
| 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) | 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) | 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) | 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 | 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 | 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 | 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 | 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 | Continuous monitoring throughout the exercise session. |
| Blood pressure | Using digital cuff system, in mmHg | Continuous monitoring throughout the exercise session. |
| Cardiac output | Using impedance cardiography, in L/min | Continuous monitoring throughout the exercise session. |
| 26453626 | Background | Spruit 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. |
| 24165798 | Background | Mador 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. |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000090003 | Blood Flow Restriction Therapy |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
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