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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OPEP only | Experimental |
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| Aerobic Exercise Group | Experimental |
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| OPEP and Aerobic Exercise | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OPEP | Device | -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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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) | Over the 24-month follow-up period |
| Measure | Description | Time Frame |
|---|---|---|
| 6-Minute Walk Distance | Measures the distance a participant can walk in six minutes as an indicator of functional exercise capacity. Higher is better. | 1, 2, 6, 12, 24 months, and over 24 months |
| All-Cause Mortality |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Huiqing Ge, MD | Sir Run Run Shaw Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sir Run Run Shaw Hospital Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310016 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34927525 | Background | Bishop JA, Spencer LM, Dwyer TJ, McKeough ZJ, McAnulty A, Alison JA. Changes in Exercise Capacity and Health-Related Quality of Life at Four and Eight Weeks of a Pulmonary Rehabilitation Program in People with COPD. COPD. 2021 Dec;18(6):612-620. doi: 10.1080/15412555.2021.2013793. Epub 2021 Dec 19. | |
| 33631128 | Background |
| Label | URL |
|---|---|
| Global initiative for chronic obstructive lung disease.Global strategy for prevention,diagnosis and management of COPD: 2024 Report | View source |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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|
| Control | No Intervention |
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| Aerobic Exercise | Behavioral | -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). |
|
| 24 months |
| Number of Acute Exacerbations | Total count of acute exacerbation events experienced by each participant. | 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. | 24 months |
| Time to First Acute Exacerbation | Duration from study start to the first recorded acute exacerbation for each participant. | 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. | 1, 2, 6, 12, and 24 months |
| Modified Medical Research Council (mMRC) Dyspnea Score | Patient-rated scale assessing the severity of breathlessness. Higher grade indicates higher severity. | 1, 2, 6, 12, and 24 months |
| St. George's Respiratory Questionnaire (SGRQ) Score | Quality of life assessment specific to respiratory diseases. Higher scores reflect worse health-related quality of life. | 1, 2, 6, 12, and 24 months |
| Changes in Lung Function Parameter-FVC | Forced Vital Capacity (FVC) measured in Liters | 1, 2, 6, 12, and 24 months |
| Changes in Lung Function Parameter-FEV1 | Forced Expiratory Volume in 1 Second (FEV1) measured in Liters | 1, 2, 6, 12, and 24 months |
| Changes in Lung Function Parameters - FEV1 predicted | Predicted Forced Expiratory Volume in 1 second (FEV1 predicted) measured in percentage, calculated using GLI-asian equation | 1, 2, 6, 12, and 24 months |
| Changes in Lung Function Parameters - FEV1/FVC ratio | Forced Expiratory Volume in the first second to Forced Vital Capacity (FEV1/FVC ratio), percentage. | 1, 2, 6, 12, and 24 months |
| Changes in Lung Function Parameters - PEF | Peak Expiratory Flow (PEF) measured in L/min | 1, 2, 6, 12, and 24 months |
| Changes in Lung Function Parameters - MMEF | Maximum Mid-Expiratory Flow (MMEF) percentage of predicted normal | 1, 2, 6, 12, and 24 months |
| Changes in Blood Gas Parameters - pH | 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. | 1, 2, 6, 12, and 24 months |
| Changes in Blood Gas Parameters - PaO2 | 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. | 1, 2, 6, 12, and 24 months |
| Changes in Blood Gas Parameters - PaCO2 | 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. | 1, 2, 6, 12, and 24 months |
| Changes in Blood Gas Parameters - PaO2/FiO2 | 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). | 1, 2, 6, 12, and 24 months |
| Changes in Blood Gas Parameters - HCO3 | 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. | 1, 2, 6, 12, and 24 months |
| Treatment Compliance | Evaluation of participants' adherence to prescribed treatments and protocols throughout the study using device data and aerobic exercise records. | 1, 2, 6, 12, and 24 months |
| Meghji J, Mortimer K, Agusti A, Allwood BW, Asher I, Bateman ED, Bissell K, Bolton CE, Bush A, Celli B, Chiang CY, Cruz AA, Dinh-Xuan AT, El Sony A, Fong KM, Fujiwara PI, Gaga M, Garcia-Marcos L, Halpin DMG, Hurst JR, Jayasooriya S, Kumar A, Lopez-Varela MV, Masekela R, Mbatchou Ngahane BH, Montes de Oca M, Pearce N, Reddel HK, Salvi S, Singh SJ, Varghese C, Vogelmeier CF, Walker P, Zar HJ, Marks GB. Improving lung health in low-income and middle-income countries: from challenges to solutions. Lancet. 2021 Mar 6;397(10277):928-940. doi: 10.1016/S0140-6736(21)00458-X. Epub 2021 Feb 22. |
| 31248666 | Background | Zhou M, Wang H, Zeng X, Yin P, Zhu J, Chen W, Li X, Wang L, Wang L, Liu Y, Liu J, Zhang M, Qi J, Yu S, Afshin A, Gakidou E, Glenn S, Krish VS, Miller-Petrie MK, Mountjoy-Venning WC, Mullany EC, Redford SB, Liu H, Naghavi M, Hay SI, Wang L, Murray CJL, Liang X. Mortality, morbidity, and risk factors in China and its provinces, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2019 Sep 28;394(10204):1145-1158. doi: 10.1016/S0140-6736(19)30427-1. Epub 2019 Jun 24. |
| 29650248 | Background | Wang C, Xu J, Yang L, Xu Y, Zhang X, Bai C, Kang J, Ran P, Shen H, Wen F, Huang K, Yao W, Sun T, Shan G, Yang T, Lin Y, Wu S, Zhu J, Wang R, Shi Z, Zhao J, Ye X, Song Y, Wang Q, Zhou Y, Ding L, Yang T, Chen Y, Guo Y, Xiao F, Lu Y, Peng X, Zhang B, Xiao D, Chen CS, Wang Z, Zhang H, Bu X, Zhang X, An L, Zhang S, Cao Z, Zhan Q, Yang Y, Cao B, Dai H, Liang L, He J; China Pulmonary Health Study Group. Prevalence and risk factors of chronic obstructive pulmonary disease in China (the China Pulmonary Health [CPH] study): a national cross-sectional study. Lancet. 2018 Apr 28;391(10131):1706-1717. doi: 10.1016/S0140-6736(18)30841-9. Epub 2018 Apr 9. |
| 35914087 | Background | Celli B, Fabbri L, Criner G, Martinez FJ, Mannino D, Vogelmeier C, Montes de Oca M, Papi A, Sin DD, Han MK, Agusti A. Definition and Nomenclature of Chronic Obstructive Pulmonary Disease: Time for Its Revision. Am J Respir Crit Care Med. 2022 Dec 1;206(11):1317-1325. doi: 10.1164/rccm.202204-0671PP. No abstract available. |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |