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NCT Number: NCT06970054

Home Oscillatory Positive Expiratory Pressure - Aerobic Exercise Rehabilitation Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sir Run Run Shaw Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310016, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

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).

Primary outcomes

  1. Incidence of AECOPD

    Time frame: 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)

  2. Hospitalization Rates of AECOPD

    Time frame: 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 outcomes

  1. 6-Minute Walk Distance

    Time frame: 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.

  2. All-Cause Mortality

    Time frame: 24 months

  3. Number of Acute Exacerbations

    Time frame: 1, 2, 6, 12, 24 months, and over 24 months

    Total count of acute exacerbation events experienced by each participant.

  4. Proportion of Participants with ≥2 Acute Exacerbations

    Time frame: 24 months

    Percentage of participants experiencing two or more acute exacerbations within 24 months.

  5. Time to First Acute Exacerbation

    Time frame: 24 months

    Duration from study start to the first recorded acute exacerbation for each participant.

  6. COPD Assessment Test (CAT) Score

    Time frame: 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.

  7. Modified Medical Research Council (mMRC) Dyspnea Score

    Time frame: 1, 2, 6, 12, and 24 months

    Patient-rated scale assessing the severity of breathlessness. Higher grade indicates higher severity.

  8. St. George's Respiratory Questionnaire (SGRQ) Score

    Time frame: 1, 2, 6, 12, and 24 months

    Quality of life assessment specific to respiratory diseases. Higher scores reflect worse health-related quality of life.

  9. Changes in Lung Function Parameter-FVC

    Time frame: 1, 2, 6, 12, and 24 months

    Forced Vital Capacity (FVC) measured in Liters

  10. Changes in Lung Function Parameter-FEV1

    Time frame: 1, 2, 6, 12, and 24 months

    Forced Expiratory Volume in 1 Second (FEV1) measured in Liters

  11. Changes in Lung Function Parameters - FEV1 predicted

    Time frame: 1, 2, 6, 12, and 24 months

    Predicted Forced Expiratory Volume in 1 second (FEV1 predicted) measured in percentage, calculated using GLI-asian equation

  12. Changes in Lung Function Parameters - FEV1/FVC ratio

    Time frame: 1, 2, 6, 12, and 24 months

    Forced Expiratory Volume in the first second to Forced Vital Capacity (FEV1/FVC ratio), percentage.

  13. Changes in Lung Function Parameters - PEF

    Time frame: 1, 2, 6, 12, and 24 months

    Peak Expiratory Flow (PEF) measured in L/min

  14. Changes in Lung Function Parameters - MMEF

    Time frame: 1, 2, 6, 12, and 24 months

    Maximum Mid-Expiratory Flow (MMEF) percentage of predicted normal

  15. Changes in Blood Gas Parameters - pH

    Time frame: 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.

  16. Changes in Blood Gas Parameters - PaO2

    Time frame: 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.

  17. Changes in Blood Gas Parameters - PaCO2

    Time frame: 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.

  18. Changes in Blood Gas Parameters - PaO2/FiO2

    Time frame: 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).

  19. Changes in Blood Gas Parameters - HCO3

    Time frame: 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.

  20. Treatment Compliance

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Sir Run Run Shaw Hospital

Other

Registry information

Official study title

Home Oscillatory Positive Expiratory Pressure Combined With Aerobic Exercise in Moderate to Severe COPD Patients: A Multicenter, Randomized Controlled Study

Acronym: HOPE-AERO

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
May 14, 2025
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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