Home Oscillatory Positive Expiratory Pressure - Aerobic Exercise Rehabilitation Study

The goal of this clinical trial is to evaluate the feasibility and effectiveness of home OPEP therapy and aerobic exercise training in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD) who are at high risk of acute exacerbations, aged 40-80 years. The main questions it aims to answer are: Does home OPEP therapy, aerobic exercise training, or the combination of both reduce the incidence and hospitalization rate of acute exacerbations of COPD compared to conventional treatment? What are the effects of these interventions on 6-minute walk distance, all-cause mortality, lung function, quality of life, and treatment adherence? Researchers will compare a) conventional treatment, b) OPEP therapy, c) aerobic exercise training, and d) OPEP therapy combined with aerobic exercise training to see if OPEP therapy and/or aerobic exercise training improve pulmonary rehabilitation outcomes. Participants will: Receive assigned intervention based on the study arm (conventional treatment, OPEP therapy, aerobic exercise, or combined therapy). Use respiratory training devices and/or wearable monitoring devices as required by their assigned group. Follow training plans and therapy schedules. Attend follow-up visits at 1 month, 2 months, 6 months, 12 months, and 24 months. Complete questionnaires and undergo assessments (e.g., lung function tests, 6-minute walk tests) at baseline and follow-up visits.

NCT Number	NCT06970054
Lead Sponsor	Sir Run Run Shaw Hospital
Conditions	COPD, AECOPD
Enrollment	312 participants
Start Date	2026-03-20
Primary Completion	2029-05 (estimated)
Study Completion	2029-07 (estimated)
Updated on ClinicalTrials.gov	2026-03-25