Home Oscillatory Positive Expiratory Pressure - Aerobic Exercise Rehabilitation Study
NCT ID: NCT06970054
Last Updated: 2025-05-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
312 participants
INTERVENTIONAL
2025-05-31
2029-07-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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).
OPEP
-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 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).
Aerobic 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).
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).
OPEP
-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 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).
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).
No interventions assigned to this group
Interventions
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OPEP
-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 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).
Eligibility Criteria
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Inclusion Criteria
* 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 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.
40 Years
80 Years
ALL
No
Sponsors
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e-Linkcare Meditech Co., Ltd.
UNKNOWN
Sir Run Run Shaw Hospital
OTHER
Responsible Party
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Huiqing Ge
Director of Respiratory Care Department
Principal Investigators
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Huiqing Ge, MD
Role: PRINCIPAL_INVESTIGATOR
Sir Run Run Shaw Hospital
Locations
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Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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References
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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.
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.
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.
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.
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.
Related Links
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Global initiative for chronic obstructive lung disease.Global strategy for prevention,diagnosis and management of COPD: 2024 Report
Other Identifiers
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20250243
Identifier Type: -
Identifier Source: org_study_id
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