Active — Not RecruitingNot Applicable

Home Oscillatory Positive Expiratory Pressure - Aerobic Exercise Rehabilitation Study

China312 participantsStarted 2026-03-20

Plain-language 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 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.

Who can participate

Age range

40 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of AECOPD

Timeframe: Over the 24-month follow-up period

Hospitalization Rates of AECOPD

Timeframe: Over the 24-month follow-up period

Trial details

NCT IDNCT06970054

SponsorSir Run Run Shaw Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-05

View on ClinicalTrials.gov More COPD trials