Home Oscillatory Positive Expiratory Pressure - Aerobic Exercise Rehabilitation Study

Launched by SIR RUN RUN SHAW HOSPITAL · May 5, 2025

Keywords

ClinConnect Summary

This clinical trial, called the Home Oscillatory Positive Expiratory Pressure - Aerobic Exercise Rehabilitation Study, is looking into how effective certain treatments are for people with moderate to severe Chronic Obstructive Pulmonary Disease (COPD), especially those at risk of sudden worsening of their condition, known as acute exacerbations. Researchers want to see if using a special breathing device at home (called OPEP therapy) or doing aerobic exercise, or a combination of both, can help reduce the number of these acute events and improve overall health compared to standard treatment. They will also measure how these treatments affect walking distance, lung function, quality of life, and how well patients stick to the treatment plans.

To be eligible for this study, participants should be between 40 and 80 years old and diagnosed with COPD that meets specific criteria. They should be seeking treatment for an acute exacerbation and must live near the study area. Patients will be assigned to one of four groups: standard treatment, OPEP therapy, aerobic exercise, or a combination of OPEP therapy and exercise. Throughout the study, which lasts up to two years, participants will follow therapy schedules, use monitoring devices, and attend regular follow-up visits for assessments and questionnaires. It's important to note that individuals with certain serious health conditions or those who might struggle to participate due to other factors will not be included in the trial.

Gender

ALL

Eligibility criteria

• 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.