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NOT YET RECRUITING
NCT07818187
NA

Effectiveness of Active Cycle of Breathing Techniques in Patients With Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial

Sponsor: National Yang Ming Chiao Tung University Hospital

View on ClinicalTrials.gov

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. 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).

Key Details

Gender

All

Age Range

40 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-09-01

Completion Date

2027-06-30

Last Updated

2026-09-14

Healthy Volunteers

No

Interventions

BEHAVIORAL

ACBT+OPEP

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.

BEHAVIORAL

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.

Locations (1)

National Yang Ming Chiao Tung University Hospital

Yilan, Taiwan, Taiwan