Home Oscillatory Positive Expiratory Pressure - Aerobic Exercise Rehabilitation Study

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

Interventions

DEVICE

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).

BEHAVIORAL

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).

Sponsors & Collaborators

• Sir Run Run Shaw Hospital

  lead OTHER

Principal Investigators

• Huiqing Ge, MD · Sir Run Run Shaw Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-03-20

Primary Completion

2029-05-31

Completion

2029-07-31

Countries

• China

Study Locations