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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45+
SponsorUniversity Hospital, Grenoble

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Blood flow restricted exercise sessionExperimental treatment 1 intervention
Group B: Standard exercise sessionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Muscle fatigue

Muscle fatigue assessed by magnetic stimulation of the femoral nerve

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

Secondary outcomes

1

Flow Mediated Dilation (FMD)

Brachial artery FMD assessed by ultrasound

Time frame
30-minutes pre-exercise, and 10 and 75-minutes post-exercise
2

Symptoms of dyspnea

Modified Borg scale: ranging from 0 (nothing at all) to 10 (maximal)

Time frame
Assessed at the end of each exercise set/bout (sub-study 1) or every 2 minutes throughout exercise (sub-study 2)
3

Leg discomfort

Modified Borg scale: ranging from 0 (nothing at all) to 10 (maximal)

Time frame
Assessed at the end of each exercise set/bout (sub-study 1) or every 2 minutes throughout exercise (sub-study 2)
4

Affective valence

Feeling scale: ranging from -5 (very bad) to 5 (very good)

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

Other outcomes

Sponsors and contacts

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