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

NCT07668921 | Not Yet Recruiting

• 2 other identifiers: EssaiClinique_2BFREEaigu2026-A00501-50
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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

Outcome Measures

Primary Outcomes (1)

• Muscle fatigue

  Muscle fatigue assessed by magnetic stimulation of the femoral nerve

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

Secondary Outcomes (12)

• Flow Mediated Dilation (FMD)

  30-minutes pre-exercise, and 10 and 75-minutes post-exercise

• Symptoms of dyspnea

  Assessed at the end of each exercise set/bout (sub-study 1) or every 2 minutes throughout exercise (sub-study 2)

• Leg discomfort

  Assessed at the end of each exercise set/bout (sub-study 1) or every 2 minutes throughout exercise (sub-study 2)

• Affective valence

  Assessed at the end of each exercise set/bout (sub-study 1) or every 2 minutes throughout exercise (sub-study 2)

• Affective intensity

  Assessed at the end of each exercise set/bout (sub-study 1) or every 2 minutes throughout exercise (sub-study 2)

Study Arms (2)

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).

Device: Blood Flow Restriction

Standard exercise session

ACTIVE COMPARATOR

Sub-study 1: resistance exercise session (RE); Sub-study 2: aerobic endurance exercise session (END).

Device: Standard exercise session

Interventions

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.

Blood flow restricted exercise session

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.

Standard exercise session

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

CReSI - Laboratoire HP2

La Tronche, Auvergne-Rhône-Alpes, 38700, France

Location

Related Publications (4)

• 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.

  PMID: 35360241 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.

  PMID: 22135284 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.

  PMID: 26453626 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.

  PMID: 24165798 BACKGROUND

MeSH Terms

Conditions

Lung Diseases; Pulmonary Disease, Chronic Obstructive

Interventions

Blood Flow Restriction Therapy

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Central Study Contacts

Bruno Degano, MD, PhD

CONTACT

+33664810986; bdegano@chu-grenoble.fr

Mathieu Marillier, PhD

CONTACT

+33681552231; mmarillier@chu-grenoble.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 25, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: June 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

FR (1)