Clinical trial NCT06970054: Home Oscillatory Positive Expiratory Pressure - Aerobic Exercise Rehabilitation Study
Official title: Home Oscillatory Positive Expiratory Pressure Combined With Aerobic Exercise in Moderate to Severe COPD Patients: A Multicenter, Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: COPD
AECOPD
Keywords: Oscillating Positive Expiratory Pressure
OPEP
COPD
AECOPD
Chronic Obstructive Pulmonary Disease
Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Airway Clearance
Global Initiative for Chronic Obstructive Lung Disease
GOLD
aerobic exercise
cardio
COPD management
Internet of Things
IoT
Lead sponsor: Sir Run Run Shaw Hospital
Sponsor class: OTHER
Collaborators: name: e-Linkcare Meditech Co., Ltd.
First posted: 2025-05-14
Enrollment: 312
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


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.

Primary outcomes:
measure: Incidence of AECOPD
timeFrame: Over the 24-month follow-up period
measure: Hospitalization Rates of AECOPD
timeFrame: Over the 24-month follow-up period
Secondary outcomes:
measure: 6-Minute Walk Distance
timeFrame: 1, 2, 6, 12, 24 months, and over 24 months
measure: All-Cause Mortality
timeFrame: 24 months
measure: Number of Acute Exacerbations
timeFrame: 1, 2, 6, 12, 24 months, and over 24 months
measure: Proportion of Participants with ≥2 Acute Exacerbations
timeFrame: 24 months
measure: Time to First Acute Exacerbation
timeFrame: 24 months
measure: COPD Assessment Test (CAT) Score
timeFrame: 1, 2, 6, 12, and 24 months
measure: Modified Medical Research Council (mMRC) Dyspnea Score
timeFrame: 1, 2, 6, 12, and 24 months
measure: St. George's Respiratory Questionnaire (SGRQ) Score
timeFrame: 1, 2, 6, 12, and 24 months
measure: Changes in Lung Function Parameter-FVC
timeFrame: 1, 2, 6, 12, and 24 months
measure: Changes in Lung Function Parameter-FEV1
timeFrame: 1, 2, 6, 12, and 24 months
measure: Changes in Lung Function Parameters - FEV1 predicted
timeFrame: 1, 2, 6, 12, and 24 months
measure: Changes in Lung Function Parameters - FEV1/FVC ratio
timeFrame: 1, 2, 6, 12, and 24 months
measure: Changes in Lung Function Parameters - PEF
timeFrame: 1, 2, 6, 12, and 24 months
measure: Changes in Lung Function Parameters - MMEF
timeFrame: 1, 2, 6, 12, and 24 months
measure: Changes in Blood Gas Parameters - pH
timeFrame: 1, 2, 6, 12, and 24 months
measure: Changes in Blood Gas Parameters - PaO2
timeFrame: 1, 2, 6, 12, and 24 months
measure: Changes in Blood Gas Parameters - PaCO2
timeFrame: 1, 2, 6, 12, and 24 months
measure: Changes in Blood Gas Parameters - PaO2/FiO2
timeFrame: 1, 2, 6, 12, and 24 months
measure: Changes in Blood Gas Parameters - HCO3
timeFrame: 1, 2, 6, 12, and 24 months
measure: Treatment Compliance
timeFrame: 1, 2, 6, 12, and 24 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Sir Run Run Shaw Hospital
name: Huiqing Ge, MD
role: PRINCIPAL_INVESTIGATOR
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