An interventional study of ACBT+OPEP and Usual Care (Standard Medical Care) in COPD (Chronic Obstructive Pulmonary Disease), sponsored by National Yang Ming Chiao Tung University Hospital. Not yet recruiting at 1 site in Taiwan. Open to participants aged 40 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by National Yang Ming Chiao Tung University Hospital · Not applicable, Interventional, and Treatment
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).
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.
5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.
This study's planned enrollment of 60 is close to the median of 62 across 3,839 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →National Yang Ming Chiao Tung University Hospital is the lead sponsor of 11 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
Behavioral: ACBT+OPEP · Behavioral: Usual Care (Standard Medical Care)
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.
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.
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
Time frame: Time Frame: T0 (Baseline), T1 (Week 4), T2 (Week 8), T3 (Week 12), T4 (Week 16)
Pulmonary function - FEV₁ Pulmonary function - FVC, Pulmonary function - FEV₁/FVC ratio
1. 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. 2. Pulmonary Function - FVC Measure: Forced Vital Capacity (FVC) Description: Post-bronchodilator FVC (L) measured via standardized spirometry under the same protocol as FEV₁ assessment. 3. 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.
Time frame: 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
Time frame: 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.
Time frame: T0 (Baseline), T1 (Week 4), T2 (Week 8), T3 (Week 12), T4 (Week 16)
Plan to share: Undecided
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Start is estimated for Sep 2026; primary completion for Jun 2027, 9 months later.
Of 1,094 non-industry interventional studies with no phase under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 9 months is below that.
Counting every sponsor, half of 1,181 studies reached it within 22 months; a quarter within 10 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Pulmonary Disease, Chronic Obstructive →
National Yang Ming Chiao Tung University Hospital