NCT06970054Active, not recruiting
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
Source: ClinicalTrials.gov · Last updated 25 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 312 (estimated)
- First submitted
- 18 Apr 2025
- Start date
- 20 Mar 2026
- Primary completion date
- May 2029
- Lead sponsor
- Sir Run Run Shaw Hospital
- Diseases
- COPD
- NCT number
- NCT06970054
What you commit to
- Study type: Interventional
- Planned participants: 312
- From 20 Mar 2026 to the primary completion date, May 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in other drug clinical trials or interventional studies.
Other illness
- 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.
- Liver or kidney failure requiring dialysis.
- Vulnerable populations (e.g., mental illness, cognitive impairment, critically ill, illiterate).
Other
- Inability to walk or tolerate the 6-minute walk test.
- Inability to cooperate with lung function tests.
- Pregnancy or lactation.
- Other reasons deemed unsuitable by the researcher.
Who the study is looking for
- 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.
Age in the registry: 40 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sir Run Run Shaw Hospital Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.