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 volunteersQualifiers
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
Crossover
Treatments tested in this trial
Blood Flow Restriction
DeviceSub-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
DeviceSub-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
Trial outcomes
Primary outcomes
Muscle fatigue
Muscle fatigue assessed by magnetic stimulation of the femoral nerve
Secondary outcomes
Flow Mediated Dilation (FMD)
Brachial artery FMD assessed by ultrasound
Symptoms of dyspnea
Modified Borg scale: ranging from 0 (nothing at all) to 10 (maximal)
Leg discomfort
Modified Borg scale: ranging from 0 (nothing at all) to 10 (maximal)
Affective valence
Feeling scale: ranging from -5 (very bad) to 5 (very good)
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: