COPD (Chronic Obstructive Pulmonary Disease)NCT07818187
Effectiveness of Active Cycle of Breathing Techniques in Patients With Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial
A study testing ACBT+OPEP in people with COPD (Chronic Obstructive Pulmonary Disease), run by National Yang Ming Chiao Tung University Hospital at 1 site in Taiwan.
Trial summary
This study aims to examine the effects of Active Cycle of Breathing Technique (ACBT) on pulmonary function, sleep quality, depressive symptoms, and dyspnea in patients with Chronic Obstructive Pulmonary Disease. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease)
- What is being tested?
- ACBT+OPEP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Diagnosed with COPD by a pulmonologist, with spirometry confirming post-bronchodilator FEV₁/FVC < 70% within the past 12 months 2. Aged between 40 and 90 years, receiving regular follow-up at the pulmonology outpatient clinic 3. Able to communicate and follow instructions in Mandarin or Taiwanese 4. Willing to participate and comply with home-based pulmonary rehabilitation intervention
Who cannot join
- 1. Active pulmonary tuberculosis, pneumothorax, or malignant respiratory disease 2. Severe cognitive impairment, intellectual disability, or communication disorder preventing instruction comprehension or intervention compliance 3. Currently in acute exacerbation of COPD, or primary diagnosis of bronchial asthma 4. GOLD Stage I COPD (mild, post-bronchodilator FEV₁ ≥ 80% predicted)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
National Yang Ming Chiao Tung University Hospital
Yilan, Taiwan, 260
Chia chi Ho, 0912797254, chelseyho494@gmail.com
About this study
This study aims to examine the effects of Active Cycle of Breathing Technique (ACBT) on pulmonary function, sleep quality, depressive symptoms, and dyspnea in patients with Chronic Obstructive Pulmonary Disease. A block-randomized crossover trial will be conducted at the pulmonology outpatient clinic of a regional teaching hospital in eastern Taiwan. Participants aged 40-90 years with physician-diagnosed COPD (post-bronchodilator FEV₁/FVC < 70%) will be randomly allocated into two groups. The total observation period is 16 weeks with 5 data collection time points: T0 (baseline), T1 (Week 4), T2 (Week 8), T3 (Week 12), and T4 (Week 16). Each intervention period lasts 8 weeks. Primary outcomes are dyspnea (mMRC) and COPD symptom burden (CAT). Secondary outcomes include pulmonary function (FEV₁, FVC), sleep quality (PSQI), and depressive symptoms (DASS-21).
Read the detailed description
Chronic Obstructive Pulmonary Disease (COPD) is a progressive and irreversible airway obstruction disease. Patients frequently experience dyspnea, sputum retention, repeated exacerbations, reduced exercise tolerance, poor sleep quality, and depressive symptoms. Traditional pulmonary rehabilitation is largely hospital-based and limited by patient age, comorbidities, transportation barriers, and healthcare resource constraints. Active Cycle of Breathing Technique (ACBT) is a non-invasive, low-cost structured breathing method comprising three phases: breathing control, thoracic expansion exercises, and forced expiration technique. Oscillatory Positive Expiratory Pressure (O-PEP) uses a tube valve device to generate oscillatory airflow and positive pressure during expiration, facilitating airway secretion mobilization and clearance. This study adopts a block-randomized crossover design. Group A receives ACBT combined with O-PEP during Weeks 1-8, then standard care during Weeks 9-16. Group B receives standard care during Weeks 1-8, then ACBT combined with O-PEP during Weeks 9-16. Intervention consists of 3 ACBT cycles followed by 10-15 O-PEP expirations, twice daily (at least 8 hours apart), for 8 weeks. All participants receive one-on-one standardized training prior to intervention, with weekly remote follow-up. The O-PEP device will be collected from Group A after Week 8 to prevent carryover. Standard care includes disease education, smoking cessation, self-management skills, and conventional breathing exercises. Data analysis will use Generalized Estimating Equations (GEE) following Intention-to-Treat (ITT) principles.
- Being tested
- ACBT+OPEP, Usual Care (Standard Medical Care)
- Keywords
- Chronic Obstructive Pulmonary Disease, Dyspnea, Depression, Sleep Disorders
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea, Depression, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACBT+OPEPBehavioural
Participants undergo an 8-week home-based pulmonary rehabilitation program combining ACBT with O-PEP therapy. At baseline (Week 0), each participant receives individual face-to-face instruction covering the three ACBT phases - Breathing Control (BC), Thoracic Expansion Exercises (TEE), and Forced Expiration Technique (FET) - and correct use of the tube-valve O-PEP device. Competency is verified by return demonstration. A practice manual, self-monitoring diary, and instructional videos are provided. Each session follows the sequence: BC → TEE ×3 → FET, immediately followed by 10-15 O-PEP exhalations, then FET, coughing, and expectoration. Sessions are performed twice daily (≥8 hours apart), 30-60 minutes per session, for 8 weeks. Biweekly remote monitoring is conducted via LINE. Upon completion, the O-PEP device is retrieved to prevent carryover contamination.
Usual Care (Standard Medical Care)Behavioural
Participants receive standard outpatient medical care only, consisting of routine pulmonology follow-up, prescribed pharmacological management (bronchodilators and/or inhaled corticosteroids as clinically indicated), and standard respiratory health education including disease self-management, smoking cessation, pursed-lip breathing, and diaphragmatic breathing. No ACBT training, O-PEP device, or individualized airway clearance instruction is provided during this period.
| Study group | Role | What they receive |
|---|---|---|
| ACBT + O-PEP First (Group A) | Experimental | Participants undergo an 8-week standardized home-based pulmonary rehabilitation program combining Active Cycle of Breathing Technique (ACBT) with Oscillatory Positive Expiratory Pressure (O-PEP) therapy. Training (Week 0): Each participant receives individual face-to-face instruction from a trained research nurse covering: (1) the three ACBT phases - Breathing Control (BC), Thoracic Expansion Exercises (TEE), and Forced Expiration Technique (FET); and (2) correct use of the tube-valve O-PEP device. Competency is verified by return demonstration. A home practice manual, self-monitoring diary, and instructional videos (via LINE group) are provided. Training Protocol (Weeks 1-8): Each session consists of one ACBT cycle (BC → TEE ×3 → FET), followed immediately by 10-15 O-PEP exhalations, then FET, coughing, and expectoration. Sessions are performed twice daily (≥8 hours apart), approximately 30-60 minutes per session. Biweekly remote monitoring is conducted by the research team via LINE Receives: Behavioral: ACBT+OPEP; Behavioral: Usual Care (Standard Medical Care) |
| Active Comparator: Usual Care First / Delayed Intervention (Group B) | Experimental | Participants in Group B receive standard outpatient medical care only during Period 1 (Weeks 1-8). Standard care consists of routine pulmonology outpatient follow-up, prescribed pharmacological management (bronchodilators and/or inhaled corticosteroids as clinically indicated), and standard respiratory health education including disease self-management, smoking cessation, pursed-lip breathing, and diaphragmatic breathing. No ACBT training, O-PEP device, practice manual, or individualized airway clearance instruction is provided during this period. Upon crossover at Week 9, participants in Group B begin the active intervention: they receive the same standardized one-on-one ACBT and O-PEP training as Group A (conducted at the Week 8 visit), and subsequently perform the home-based ACBT combined with O-PEP protocol twice daily for 8 weeks (Weeks 9-16), following the identical protocol delivered to Group A during Period 1. Receives: Behavioral: ACBT+OPEP; Behavioral: Usual Care (Standard Medical Care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dyspnea - mMRC, COPD Symptoms - CAT
Modified Medical Research Council Dyspnea Scale; 5-grade scale (Grade 0-4); higher score = more severe dyspnea; ICC = 0.83-0.91, COPD Assessment Test; 8-item scale scored 0-40; higher score = worse health status; ICC = 0.80-0.96
Measured: Time Frame: T0 (Baseline), T1 (Week 4), T2 (Week 8), T3 (Week 12), T4 (Week 16)
Secondary outcomes (3)
Pulmonary function - FEV₁ Pulmonary function - FVC, Pulmonary function - FEV₁/FVC ratio
- Pulmonary Function - FEV₁ Measure: Forced Expiratory Volume in 1 Second (FEV₁) Description: Post-bronchodilator FEV₁ (L and % predicted) measured via standardized spirometry following inhalation of Berotec N MDI 100 mcg × 4 doses (total 400 mcg), with re-measurement at 15 minutes post-inhalation. Conducted at the hospital pulmonary function laboratory.
- Pulmonary Function - FVC Measure: Forced Vital Capacity (FVC) Description: Post-bronchodilator FVC (L) measured via standardized spirometry under the same protocol as FEV₁ assessment.
- Pulmonary Function - FEV₁/FVC Ratio
Measure: FEV₁/FVC Ratio (%)
Description: Ratio of post-bronchodilator FEV₁ to FVC, used to confirm airflow obstruction severity per GOLD criteria.
Measured: T0 (Baseline), T1 (Week 4), T2 (Week 8), T3 (Week 12), T4 (Week 16)
Sleep Quality
Sleep Quality Measure: Pittsburgh Sleep Quality Index (PSQI) - Chinese Version Description: A 19-item self-report questionnaire assessing sleep quality over the past month across 7 components: subjective sleep quality, sleep latency, sleep duration, habitual sleep
Measured: T0 (Baseline), T1 (Week 4), T2 (Week 8), T3 (Week 12), T4 (Week 16)
Depressive Symptoms
Depression Anxiety Stress Scales-21 (DASS-21), Chinese Version Description: The Chinese version of the Depression Anxiety Stress Scales-21 (DASS-21) is a validated self-report questionnaire consisting of 21 items that assesses three domains: depression, anxiety, and stress (7 items per subscale). Each item is scored on a 4-point Likert scale ranging from 0 ("Did not apply to me at all") to 3 ("Applied to me very much or most of the time"). Scores for each subscale are summed and multiplied by two to obtain the final score, with higher scores indicating greater severity of depressive symptoms. In this study, the depression subscale score will be used to evaluate depressive symptoms.
Measured: T0 (Baseline), T1 (Week 4), T2 (Week 8), T3 (Week 12), T4 (Week 16)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD (Chronic Obstructive Pulmonary Disease)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07818187
- Sponsor's protocol ID
- 2026B004
- Status last verified
- Aug 2026
- First submitted
- 8 Sep 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Active Cycle of Breathing Techniques in Patients With Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07818187
- Acronym / sponsor ID
- 2026B004
- Keywords
- Chronic Obstructive Pulmonary Disease, Dyspnea, Depression, Sleep Disorders
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Yang Ming Chiao Tung University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 14 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to examine the effects of Active Cycle of Breathing Technique (ACBT) on pulmonary function, sleep quality, depressive symptoms, and dyspnea in patients with Chronic Obstructive Pulmonary Disease. A block-randomized crossover trial will be conducted at the pulmonology outpatient clinic of a regional teaching hospital in eastern Taiwan. Participants aged 40-90 years with physician-diagnosed COPD (post-bronchodilator FEV₁/FVC < 70%) will be randomly allocated into two groups. The total observation period is 16 weeks with 5 data collection time points: T0 (baseline), T1 (Week 4), T2 (Week 8), T3 (Week 12), and T4 (Week 16). Each intervention period lasts 8 weeks. Primary outcomes are dyspnea (mMRC) and COPD symptom burden (CAT). Secondary outcomes include pulmonary function (FEV₁, FVC), sleep quality (PSQI), and depressive symptoms (DASS-21).
Detailed description
Chronic Obstructive Pulmonary Disease (COPD) is a progressive and irreversible airway obstruction disease. Patients frequently experience dyspnea, sputum retention, repeated exacerbations, reduced exercise tolerance, poor sleep quality, and depressive symptoms. Traditional pulmonary rehabilitation is largely hospital-based and limited by patient age, comorbidities, transportation barriers, and healthcare resource constraints. Active Cycle of Breathing Technique (ACBT) is a non-invasive, low-cost structured breathing method comprising three phases: breathing control, thoracic expansion exercises, and forced expiration technique. Oscillatory Positive Expiratory Pressure (O-PEP) uses a tube valve device to generate oscillatory airflow and positive pressure during expiration, facilitating airway secretion mobilization and clearance. This study adopts a block-randomized crossover design. Group A receives ACBT combined with O-PEP during Weeks 1-8, then standard care during Weeks 9-16. Group B receives standard care during Weeks 1-8, then ACBT combined with O-PEP during Weeks 9-16. Intervention consists of 3 ACBT cycles followed by 10-15 O-PEP expirations, twice daily (at least 8 hours apart), for 8 weeks. All participants receive one-on-one standardized training prior to intervention, with weekly remote follow-up. The O-PEP device will be collected from Group A after Week 8 to prevent carryover. Standard care includes disease education, smoking cessation, self-management skills, and conventional breathing exercises. Data analysis will use Generalized Estimating Equations (GEE) following Intention-to-Treat (ITT) principles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACBT + O-PEP First (Group A) | Experimental | Behavioral: ACBT+OPEP, Behavioral: Usual Care (Standard Medical Care)Participants undergo an 8-week standardized home-based pulmonary rehabilitation program combining Active Cycle of Breathing Technique (ACBT) with Oscillatory Positive Expiratory Pressure (O-PEP) therapy. Training (Week 0): Each participant receives individual face-to-face instruction from a trained research nurse covering: (1) the three ACBT phases - Breathing Control (BC), Thoracic Expansion Exercises (TEE), and Forced Expiration Technique (FET); and (2) correct use of the tube-valve O-PEP device. Competency is verified by return demonstration. A home practice manual, self-monitoring diary, and instructional videos (via LINE group) are provided. Training Protocol (Weeks 1-8): Each session consists of one ACBT cycle (BC → TEE ×3 → FET), followed immediately by 10-15 O-PEP exhalations, then FET, coughing, and expectoration. Sessions are performed twice daily (≥8 hours apart), approximately 30-60 minutes per session. Biweekly remote monitoring is conducted by the research team via LINE |
| Active Comparator: Usual Care First / Delayed Intervention (Group B) | Experimental | Behavioral: ACBT+OPEP, Behavioral: Usual Care (Standard Medical Care)Participants in Group B receive standard outpatient medical care only during Period 1 (Weeks 1-8). Standard care consists of routine pulmonology outpatient follow-up, prescribed pharmacological management (bronchodilators and/or inhaled corticosteroids as clinically indicated), and standard respiratory health education including disease self-management, smoking cessation, pursed-lip breathing, and diaphragmatic breathing. No ACBT training, O-PEP device, practice manual, or individualized airway clearance instruction is provided during this period. Upon crossover at Week 9, participants in Group B begin the active intervention: they receive the same standardized one-on-one ACBT and O-PEP training as Group A (conducted at the Week 8 visit), and subsequently perform the home-based ACBT combined with O-PEP protocol twice daily for 8 weeks (Weeks 9-16), following the identical protocol delivered to Group A during Period 1. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Diagnosed with COPD by a pulmonologist, with spirometry confirming post-bronchodilator FEV₁/FVC < 70% within the past 12 months 2. Aged between 40 and 90 years, receiving regular follow-up at the pulmonology outpatient clinic 3. Able to communicate and follow instructions in Mandarin or Taiwanese 4. Willing to participate and comply with home-based pulmonary rehabilitation intervention
Key exclusion criteria (1 listed)
- 1. Active pulmonary tuberculosis, pneumothorax, or malignant respiratory disease 2. Severe cognitive impairment, intellectual disability, or communication disorder preventing instruction comprehension or intervention compliance 3. Currently in acute exacerbation of COPD, or primary diagnosis of bronchial asthma 4. GOLD Stage I COPD (mild, post-bronchodilator FEV₁ ≥ 80% predicted)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACBT+OPEPParticipants undergo an 8-week home-based pulmonary rehabilitation program combining ACBT with O-PEP therapy. At baseline (Week 0), each participant receives individual face-to-face instruction covering the three ACBT phases - Breathing Control (BC), Thoracic Expansion Exercises (TEE), and Forced Expiration Technique (FET) - and correct use of the tube-valve O-PEP device. Competency is verified by return demonstration. A practice manual, self-monitoring diary, and instructional videos are provided. Each session follows the sequence: BC → TEE ×3 → FET, immediately followed by 10-15 O-PEP exhalations, then FET, coughing, and expectoration. Sessions are performed twice daily (≥8 hours apart), 30-60 minutes per session, for 8 weeks. Biweekly remote monitoring is conducted via LINE. Upon completion, the O-PEP device is retrieved to prevent carryover contamination. | Behavioural | ACBT + O-PEP First (Group A), Active Comparator: Usual Care First / Delayed Intervention (Group B) |
| Usual Care (Standard Medical Care)Participants receive standard outpatient medical care only, consisting of routine pulmonology follow-up, prescribed pharmacological management (bronchodilators and/or inhaled corticosteroids as clinically indicated), and standard respiratory health education including disease self-management, smoking cessation, pursed-lip breathing, and diaphragmatic breathing. No ACBT training, O-PEP device, or individualized airway clearance instruction is provided during this period. | Behavioural | ACBT + O-PEP First (Group A), Active Comparator: Usual Care First / Delayed Intervention (Group B) |
Primary outcome
Dyspnea - mMRC, COPD Symptoms - CAT
Time frame: Time Frame: T0 (Baseline), T1 (Week 4), T2 (Week 8), T3 (Week 12), T4 (Week 16)
Modified Medical Research Council Dyspnea Scale; 5-grade scale (Grade 0-4); higher score = more severe dyspnea; ICC = 0.83-0.91, COPD Assessment Test; 8-item scale scored 0-40; higher score = worse health status; ICC = 0.80-0.96
3 secondary outcomes
Pulmonary function - FEV₁ Pulmonary function - FVC, Pulmonary function - FEV₁/FVC ratio
Time frame: T0 (Baseline), T1 (Week 4), T2 (Week 8), T3 (Week 12), T4 (Week 16)
Sleep Quality
Time frame: T0 (Baseline), T1 (Week 4), T2 (Week 8), T3 (Week 12), T4 (Week 16)
Depressive Symptoms
Time frame: T0 (Baseline), T1 (Week 4), T2 (Week 8), T3 (Week 12), T4 (Week 16)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACBT+OPEP in people with COPD (Chronic Obstructive Pulmonary Disease), run by National Yang Ming Chiao Tung University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chia chi Ho (+886912797254, chelseyho494@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dyspnea - mMRC, COPD Symptoms - CAT (time frame: Time Frame: T0 (Baseline), T1 (Week 4), T2 (Week 8), T3 (Week 12), T4 (Week 16)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.