Home Oscillatory Positive Expiratory Pressure Combined With Aerobic Exercise in Moderate to Severe COPD Patients: A Multicenter, Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 312
- 试验地点
- 1
- 主要终点
- Hospitalization Rates of AECOPD
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40-80 years.
- •Diagnosis of AECOPD according to 2025 GOLD criteria, GOLD stage 2-
- •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.
排除标准
- •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.
研究组 & 干预措施
OPEP only
- Patients are provided with an internet-connected 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).
干预措施: OPEP (Device)
Aerobic Exercise Group
- 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).
干预措施: Aerobic Exercise (Behavioral)
OPEP and Aerobic Exercise
- Patients receive both an internet-connected handheld respiratory training device and a wearable device.
- Patients receive OPEP and aerobic exercise training plans and instructions.
- Training is conducted:
- Inpatients: Twice daily OPEP training and 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).
干预措施: OPEP (Device)
OPEP and Aerobic Exercise
- Patients receive both an internet-connected handheld respiratory training device and a wearable device.
- Patients receive OPEP and aerobic exercise training plans and instructions.
- Training is conducted:
- Inpatients: Twice daily OPEP training and 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).
干预措施: Aerobic Exercise (Behavioral)
Control
- Patients are advised to maintain their usual activity levels.
- Patients continue with their prescribed medications.
- Patients receive routine management, including outpatient education.
- No specific interventions like respiratory training devices or structured exercise programs are provided.
- 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).
结局指标
主要结局
Hospitalization Rates of AECOPD
时间窗: Over the 24-month follow-up period
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)
Incidence of AECOPD
时间窗: Over the 24-month follow-up period
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)
次要结局
- 6-Minute Walk Distance(1, 2, 6, 12, 24 months, and over 24 months)
- All-Cause Mortality(24 months)
- St. George's Respiratory Questionnaire (SGRQ) Score(1, 2, 6, 12, and 24 months)
- Changes in Lung Function Parameters - MMEF(1, 2, 6, 12, and 24 months)
- Changes in Blood Gas Parameters - pH(1, 2, 6, 12, and 24 months)
- Number of Acute Exacerbations(1, 2, 6, 12, 24 months, and over 24 months)
- Proportion of Participants with ≥2 Acute Exacerbations(24 months)
- Time to First Acute Exacerbation(24 months)
- COPD Assessment Test (CAT) Score(1, 2, 6, 12, and 24 months)
- Modified Medical Research Council (mMRC) Dyspnea Score(1, 2, 6, 12, and 24 months)
- Changes in Lung Function Parameter-FVC(1, 2, 6, 12, and 24 months)
- Changes in Lung Function Parameter-FEV1(1, 2, 6, 12, and 24 months)
- Changes in Lung Function Parameters - FEV1 predicted(1, 2, 6, 12, and 24 months)
- Changes in Lung Function Parameters - FEV1/FVC ratio(1, 2, 6, 12, and 24 months)
- Changes in Lung Function Parameters - PEF(1, 2, 6, 12, and 24 months)
- Changes in Blood Gas Parameters - PaO2(1, 2, 6, 12, and 24 months)
- Changes in Blood Gas Parameters - PaCO2(1, 2, 6, 12, and 24 months)
- Changes in Blood Gas Parameters - PaO2/FiO2(1, 2, 6, 12, and 24 months)
- Changes in Blood Gas Parameters - HCO3(1, 2, 6, 12, and 24 months)
- Treatment Compliance(1, 2, 6, 12, and 24 months)
研究者
Huiqing Ge
Director of Respiratory Care Department
Sir Run Run Shaw Hospital