Home Oscillatory Positive Expiratory Pressure - Aerobic Exercise Rehabilitation Study

NCT06970054 | Active Not Recruiting

• 1 other identifier: 20250243
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD; AECOPD

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

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (20)

• 6-Minute Walk Distance

  1, 2, 6, 12, 24 months, and over 24 months

• All-Cause Mortality

  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

Study Arms (4)

OPEP only

EXPERIMENTAL

* 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).

Device: OPEP

Aerobic Exercise Group

EXPERIMENTAL

* 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).

Behavioral: Aerobic Exercise

OPEP and Aerobic Exercise

EXPERIMENTAL

* 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).

Device: OPEP; Behavioral: Aerobic Exercise

Control

NO INTERVENTION

* 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).

Interventions

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).

OPEP and Aerobic Exercise; OPEP only

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).

Aerobic Exercise Group; OPEP and Aerobic Exercise

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sir Run Run Shaw Hospital: lead

Study Sites (1)

Sir Run Run Shaw Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310016, China

Location

Related Publications (5)

• 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.

  PMID: 34927525 BACKGROUND

• 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.

  PMID: 33631128 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.

  PMID: 31248666 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.

  PMID: 29650248 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.

  PMID: 35914087 BACKGROUND

Related Links

• Global initiative for chronic obstructive lung disease.Global strategy for prevention,diagnosis and management of COPD: 2024 Report

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Exercise

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Huiqing Ge, MD

  Sir Run Run Shaw Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Respiratory Care Department

Study Record Dates

• First Submitted: April 18, 2025
• First Posted: May 14, 2025
• Study Start: March 20, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): July 1, 2029
• Last Updated: March 25, 2026

Record last verified: 2025-04

Locations

CN (1)