Effectiveness of Active Cycle of Breathing Techniques in Patients With Chronic Obstructive Pulmonary Disease: A Randomized Controlled Trial
2026년 9월 8일 업데이트: National Yang Ming Chiao Tung University Hospital
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).
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (추정된)
60
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Chia chi Ho
- 전화번호: +886912797254
- 이메일: chelseyho494@gmail.com
연구 장소
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Taiwan
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Yilan, Taiwan, 대만, 260
- National Yang Ming Chiao Tung University Hospital
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연락하다:
- Chia chi Ho
- 전화번호: 0912797254
- 이메일: chelseyho494@gmail.com
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-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: ACBT + O-PEP First (Group A)
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
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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.
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실험적: Active Comparator: Usual Care First / Delayed Intervention (Group B)
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.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Dyspnea - mMRC, COPD Symptoms - CAT
기간: Time Frame: T0 (Baseline), T1 (Week 4), T2 (Week 8), T3 (Week 12), T4 (Week 16)
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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
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Time Frame: T0 (Baseline), T1 (Week 4), T2 (Week 8), T3 (Week 12), T4 (Week 16)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Pulmonary function - FEV₁ Pulmonary function - FVC, Pulmonary function - FEV₁/FVC ratio
기간: T0 (Baseline), T1 (Week 4), T2 (Week 8), T3 (Week 12), T4 (Week 16)
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Measure: FEV₁/FVC Ratio (%) Description: Ratio of post-bronchodilator FEV₁ to FVC, used to confirm airflow obstruction severity per GOLD criteria. |
T0 (Baseline), T1 (Week 4), T2 (Week 8), T3 (Week 12), T4 (Week 16)
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Sleep Quality
기간: T0 (Baseline), T1 (Week 4), T2 (Week 8), T3 (Week 12), T4 (Week 16)
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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
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T0 (Baseline), T1 (Week 4), T2 (Week 8), T3 (Week 12), T4 (Week 16)
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Depressive Symptoms
기간: T0 (Baseline), T1 (Week 4), T2 (Week 8), T3 (Week 12), T4 (Week 16)
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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.
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T0 (Baseline), T1 (Week 4), T2 (Week 8), T3 (Week 12), T4 (Week 16)
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여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 9월 1일
기본 완료 (추정된)
2027년 6월 30일
연구 완료 (추정된)
2027년 6월 30일
연구 등록 날짜
최초 제출
2026년 9월 8일
QC 기준을 충족하는 최초 제출
2026년 9월 8일
처음 게시됨 (실제)
2026년 9월 14일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 14일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 8일
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2026B004
개별 참가자 데이터(IPD) 계획
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미정
약물 및 장치 정보, 연구 문서
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아니
미국 FDA 규제 기기 제품 연구
아니
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