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

NCT07818187 | Not Yet Recruiting

• 1 other identifier: 2026B004
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

COPD (Chronic Obstructive Pulmonary Disease)

Keywords

Chronic Obstructive Pulmonary Disease; Dyspnea; Depression; Sleep Disorders

Outcome Measures

Primary Outcomes (1)

• 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: 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

  T0 (Baseline), T1 (Week 4), T2 (Week 8), T3 (Week 12), T4 (Week 16)

• Sleep Quality

  T0 (Baseline), T1 (Week 4), T2 (Week 8), T3 (Week 12), T4 (Week 16)

• Depressive Symptoms

  T0 (Baseline), T1 (Week 4), T2 (Week 8), T3 (Week 12), T4 (Week 16)

Study Arms (2)

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

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.

Behavioral: ACBT+OPEP; Behavioral: Usual Care (Standard Medical Care)

Interventions

ACBT+OPEP BEHAVIORAL

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.

ACBT + O-PEP First (Group A); Active Comparator: Usual Care First / Delayed Intervention (Group B)

Usual Care (Standard Medical Care) BEHAVIORAL

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.

ACBT + O-PEP First (Group A); Active Comparator: Usual Care First / Delayed Intervention (Group B)

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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

You may not qualify if:

• \. 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)

Sponsors & Collaborators

• National Yang Ming Chiao Tung University Hospital: lead

Study Sites (1)

National Yang Ming Chiao Tung University Hospital

Yilan, Taiwan, 260, Taiwan

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Dyspnea; Depression; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Behavioral Symptoms; Behavior; Nervous System Diseases; Neurologic Manifestations; Mental Disorders

Central Study Contacts

Chia chi Ho

CONTACT

+886912797254; chelseyho494@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2026
• First Posted: September 14, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: September 14, 2026

Record last verified: 2026-08

Locations

TW (1)