Efficacy of blood flow restriction combined with low-intensity aerobic training in patients with COPD: Study protocol for the BREATH randomized controlled trial.
Huang YT, Cheng HC, Yang HL, Hung CH, Wu TY, Kuo CW et al. · Contemporary clinical trials · 2026
Introduction: Chronic obstructive pulmonary disease (COPD) is characterized by persistent airflow limitation, which reduces exercise capacity. Although current guidelines recommend moderate-to-vigorous aerobic exercise to achieve optimal physiological adaptations, many patients cannot sustain the required intensity, limiting overall therapeutic benefit. This study protocol
Aims: to evaluate the effects of combining blood flow restriction (BFR) with aerobic training on exercise capacity, cardiopulmonary function, and health-related quality of life in patients with COPD, compared with conventional aerobic training or usual care.
Methods: We will conduct a single-center, prospective, parallel-group randomized controlled trial. 45 clinically stable patients with COPD (GOLD stages II-IV) will be recruited. Eligible participants must have had no acute exacerbations in the past two months and be able to participate in the exercise training program. Participants will be randomly assigned to one of three groups: usual care, conventional aerobic training (60-80% VO₂ peak), or BFR-enhanced aerobic training (40-50% VO₂ peak, with 40-80% arterial occlusion pressure). All exercise sessions will be supervised, three times per week for eight weeks. The primary outcome is exercise capacity. Secondary outcomes include pulmonary function tests, respiratory muscle strength, diaphragmatic ultrasound, heart rate variability, and health-related quality-of-life questionnaires. Planned outcomes BFR-enhanced aerobic training may be a safe and effective rehabilitation option for COPD patients who cannot tolerate high-intensity exercise. The BREATH trial is expected to provide essential evidence for clinical care by integrating BFR training into pulmonary rehabilitation. This approach could inform future management strategies for exercise intolerance among patients with COPD. Trial registration The study has been approved by the Institutional Review Board (approval number: B-ER-113-298) and registered on ClinicalTrials.gov (registration number: NCT06756646).