Home Oscillatory Positive Expiratory Pressure - Aerobic Exercise Rehabilitation Study

Home Oscillatory Positive Expiratory Pressure Combined With Aerobic Exercise in Moderate to Severe COPD Patients: A Multicenter, Randomized Controlled 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.

Inclusion Criteria:

• Age 40-80 years.
• Diagnosis of AECOPD according to 2025 GOLD criteria, GOLD stage 2-4.
• Patients seeking treatment for acute exacerbation of COPD (AECOPD) as outpatients or inpatients.
• Residing in the study center area with no plans to relocate during the study.
• Voluntary participation with signed informed consent.

Exclusion Criteria:

• Inability to walk or tolerate the 6-minute walk test.
• Inability to cooperate with lung function tests.
• Life expectancy <6 months (e.g., uncontrolled advanced malignancy, recent MI, unstable angina, acute stroke, acute heart failure).
• Active pulmonary tuberculosis or history of lung resection.
• Pregnancy or lactation.
• Liver or kidney failure requiring dialysis.
• Participation in other drug clinical trials or interventional studies.
• Vulnerable populations (e.g., mental illness, cognitive impairment, critically ill, illiterate).
• Other reasons deemed unsuitable by the researcher.