Status:
NOT_YET_RECRUITING
Home Oscillatory Positive Expiratory Pressure - Aerobic Exercise Rehabilitation Study
Lead Sponsor:
Sir Run Run Shaw Hospital
Collaborating Sponsors:
e-Linkcare Meditech Co., Ltd.
Conditions:
COPD
AECOPD
Eligibility:
All Genders
40-80 years
Phase:
NA
Brief Summary
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 Di...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2029
Estimated Enrollment :
312 Patients enrolled
Trial Details
Trial ID
NCT06970054
Start Date
May 1 2025
End Date
July 1 2029
Last Update
May 14 2025
Active Locations (1)
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1
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310016