COPD, AECOPD
Conditions
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
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.
Interventions
DEVICEOPEP
-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).
BEHAVIORALAerobic Exercise
-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).
Sponsors
Sir Run Run Shaw Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of AECOPD | 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) |
| Hospitalization Rates of AECOPD | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 6-Minute Walk Distance | 1, 2, 6, 12, 24 months, and over 24 months | Measures the distance a participant can walk in six minutes as an indicator of functional exercise capacity. Higher is better. |
| All-Cause Mortality | 24 months | — |
| Number of Acute Exacerbations | 1, 2, 6, 12, 24 months, and over 24 months | Total count of acute exacerbation events experienced by each participant. |
| Proportion of Participants with ≥2 Acute Exacerbations | 24 months | Percentage of participants experiencing two or more acute exacerbations within 24 months. |
| Time to First Acute Exacerbation | 24 months | Duration from study start to the first recorded acute exacerbation for each participant. |
| COPD Assessment Test (CAT) Score | 1, 2, 6, 12, and 24 months | 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. |
| Modified Medical Research Council (mMRC) Dyspnea Score | 1, 2, 6, 12, and 24 months | Patient-rated scale assessing the severity of breathlessness. Higher grade indicates higher severity. |
| St. George's Respiratory Questionnaire (SGRQ) Score | 1, 2, 6, 12, and 24 months | Quality of life assessment specific to respiratory diseases. Higher scores reflect worse health-related quality of life. |
| Changes in Lung Function Parameter-FVC | 1, 2, 6, 12, and 24 months | Forced Vital Capacity (FVC) measured in Liters |
| Changes in Lung Function Parameter-FEV1 | 1, 2, 6, 12, and 24 months | Forced Expiratory Volume in 1 Second (FEV1) measured in Liters |
| Changes in Lung Function Parameters - FEV1 predicted | 1, 2, 6, 12, and 24 months | Predicted Forced Expiratory Volume in 1 second (FEV1 predicted) measured in percentage, calculated using GLI-asian equation |
| Changes in Lung Function Parameters - FEV1/FVC ratio | 1, 2, 6, 12, and 24 months | Forced Expiratory Volume in the first second to Forced Vital Capacity (FEV1/FVC ratio), percentage. |
| Changes in Lung Function Parameters - PEF | 1, 2, 6, 12, and 24 months | Peak Expiratory Flow (PEF) measured in L/min |
| Changes in Lung Function Parameters - MMEF | 1, 2, 6, 12, and 24 months | Maximum Mid-Expiratory Flow (MMEF) percentage of predicted normal |
| Changes in Blood Gas Parameters - pH | 1, 2, 6, 12, and 24 months | In arterial blood gas test, pH is a measurement of the acid-base balance of the blood. A normal blood pH range is between 7.35 and 7.45. A pH below 7.35 indicates acidosis, while a pH above 7.45 indicates alkalosis. pH has no units. |
| Changes in Blood Gas Parameters - PaO2 | 1, 2, 6, 12, and 24 months | Partial pressure of oxygen (PaO2), in blood gas analysis measures the amount of dissolved oxygen in arterial blood. It's an indicator of oxygenation and is measured in millimeters of mercury (mmHg). A normal PaO2 range is 80-100 mmHg. |
| Changes in Blood Gas Parameters - PaCO2 | 1, 2, 6, 12, and 24 months | Partial pressure of carbon dioxide (PaCO2), is a measure of the amount of dissolved carbon dioxide in arterial blood. It's a key indicator of ventilation status, essentially reflecting how well the lungs are removing CO2. It is measured in millimeter mercury (mmHg) and a normal PaCO2 range is 35-45 mmHg. |
| Changes in Blood Gas Parameters - PaO2/FiO2 | 1, 2, 6, 12, and 24 months | PaO2/FiO2 ratio is the ratio of arterial oxygen partial pressure (PaO2 in mmHg) to fractional inspired oxygen (FiO2 expressed as a fraction, not a percentage). |
| Changes in Blood Gas Parameters - HCO3 | 1, 2, 6, 12, and 24 months | HCO3 refers to the bicarbonate level in the blood, which is a crucial component of acid-base balance. A normal HCO3 range on an ABG is typically between 22 and 26 mEq/L. |
| Treatment Compliance | 1, 2, 6, 12, and 24 months | Evaluation of participants' adherence to prescribed treatments and protocols throughout the study using device data and aerobic exercise records. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORHuiqing Ge, MD
Sir Run Run Shaw Hospital
Outcome results
None listed