Home Oscillatory Positive Expiratory Pressure - Aerobic Exercise Rehabilitation Study

N/ANot Yet RecruitingNCT06970054

Sir Run Run Shaw Hospital312 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

312

Conditions

COPD

Interventions

OPEPDEVICE

-Patients are provided with a networked handheld respiratory training device. -Patients are provided with a wearable device for monitoring data. -Patients receive an OPEP training plan and instructions on using the respiratory training device. -Training on the OPEP device is conducted: -Inpatients: Twice daily training during hospitalization. -Outpatients: At least 3 training sessions in the clinic after enrollment. -Treatment compliance is monitored remotely via the IoT system for 8 weeks. -Patients are scheduled for regular follow-up visits at 1 month, 2 months, 6 months, 12 months, and 24 months (with a window of ±7 days for each visit).

Aerobic ExerciseBEHAVIORAL

-Patients are provided with a wearable device for monitoring data. -Patients receive an aerobic exercise training plan and instructions on using the device. -Exercise training is conducted: -Inpatients: Daily aerobic exercise during hospitalization. -Outpatients: At least 3 training sessions in the clinic after enrollment. -Treatment compliance is monitored remotely via the IoT system for 8 weeks. -Patients are scheduled for regular follow-up visits at 1 month, 2 months, 6 months, 12 months, and 24 months (with a window of ±7 days for each visit).

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Sir Run Run Shaw Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Outcomes

Primary Outcomes

Incidence of AECOPD

Incidence of moderate to severe acute exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD). Acute exacerbation of COPD is defined according to the Chinese expert consensus on diagnosis and treatment of acute exacerbation of chronic obstructive pulmonary disease (revised edition 2023)

Time frame: Over the 24-month follow-up period

Hospitalization Rates of AECOPD

Hospitalization rate of moderate to severe acute exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD). Acute exacerbation of COPD is defined according to the Chinese expert consensus on diagnosis and treatment of acute exacerbation of chronic obstructive pulmonary disease (revised edition 2023)

Time frame: Over the 24-month follow-up period

Secondary Outcomes

6-Minute Walk Distance

Measures the distance a participant can walk in six minutes as an indicator of functional exercise capacity. Higher is better.

Time frame: 1, 2, 6, 12, 24 months, and over 24 months

All-Cause Mortality

Time frame: 24 months

Number of Acute Exacerbations

Total count of acute exacerbation events experienced by each participant.

Time frame: 1, 2, 6, 12, 24 months, and over 24 months

Proportion of Participants with ≥2 Acute Exacerbations

Percentage of participants experiencing two or more acute exacerbations within 24 months.

Time frame: 24 months

Time to First Acute Exacerbation

Duration from study start to the first recorded acute exacerbation for each participant.

Time frame: 24 months

COPD Assessment Test (CAT) Score

Self-reported measure of health status in COPD patients, assessed using the CAT questionnaire. Higher scores indicate a greater impact of COPD on a patient's daily life.