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

8 septembre 2026 mis à jour par: 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).

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

60

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Taïwan
    • Taiwan
      • Yilan, Taiwan, Taïwan, 260
        • National Yang Ming Chiao Tung University Hospital
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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)

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation croisée
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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
Comportemental: 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.
Comportemental: 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.
Expérimental: 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.
Comportemental: 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.
Comportemental: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Dyspnea - mMRC, COPD Symptoms - CAT
Délai: 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
Time Frame: T0 (Baseline), T1 (Week 4), T2 (Week 8), T3 (Week 12), T4 (Week 16)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Pulmonary function - FEV₁ Pulmonary function - FVC, Pulmonary function - FEV₁/FVC ratio
Délai: T0 (Baseline), T1 (Week 4), T2 (Week 8), T3 (Week 12), T4 (Week 16)

  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.
T0 (Baseline), T1 (Week 4), T2 (Week 8), T3 (Week 12), T4 (Week 16)
Sleep Quality
Délai: T0 (Baseline), T1 (Week 4), T2 (Week 8), T3 (Week 12), T4 (Week 16)
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
T0 (Baseline), T1 (Week 4), T2 (Week 8), T3 (Week 12), T4 (Week 16)
Depressive Symptoms
Délai: T0 (Baseline), T1 (Week 4), T2 (Week 8), T3 (Week 12), T4 (Week 16)
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.
T0 (Baseline), T1 (Week 4), T2 (Week 8), T3 (Week 12), T4 (Week 16)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

National Yang Ming Chiao Tung University Hospital

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 septembre 2026

Achèvement primaire (Estimé)

30 juin 2027

Achèvement de l'étude (Estimé)

30 juin 2027

Dates d'inscription aux études

Première soumission

8 septembre 2026

Première soumission répondant aux critères de contrôle qualité

8 septembre 2026

Première publication (Réel)

14 septembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

14 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

8 septembre 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 2026B004

Plan pour les données individuelles des participants (IPD)

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INDÉCIS

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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