- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07742033
Active Cycle Of Breathing Technique And Pursed Lip Breathing in Moderate to Severe COPD Patients
Purpose of the Study Chronic Obstructive Pulmonary Disease (COPD) is a progressive, long-term lung condition that limits airflow and makes breathing difficult. People with COPD frequently experience shortness of breath, chronic coughing, and mucus buildup, which can severely impact their daily activities and overall quality of life. While medications are commonly used, non drug therapies like specialized breathing exercises are becoming vital tools to help relieve symptoms.
The purpose of this study is to compare two popular breathing techniques the Active Cycle of Breathing Technique (ACBT) and Pursed-Lip Breathing (PLB) to determine which method is more effective at improving lung function, reducing breathlessness, and enhancing the overall quality of life for individuals living with moderate to severe COPD.
Study Plan and Methods
This study is a randomized controlled trial lasting approximately 8 to 10 months. A total of 40 eligible participants (both men and women aged 40 to 55) will be recruited and randomly split into two equal groups:
Group A (Active Cycle Breathing): Participants will practice ACBT, which combines relaxed breathing, deep chest-expanding breaths, and a specialized coughing technique ("huffing") to clear trapped mucus from the lungs Group B (Pursed-Lip Breathing): Participants will practice PLB, a technique where they inhale slowly through the nose and exhale gently through puckered lips (like blowing out a candle) to slow down breathing and improve ventilation Both groups will receive their assigned breathing exercise alongside standard medical care and a baseline postural drainage treatment. Exercises will be performed in 15-to-20-minute sessions, twice a day, for a total of 8 weeks.
Expected Outcomes Researchers will evaluate participants before and after the 8-week program using standard lung function tests (spirometry), breathlessness questionnaires, and quality-of-life assessments. The study expects both techniques to offer relief, but aims to identify if one method provides superior evidence-based benefits. The ultimate goal is to help physical therapists and doctors design more effective, personalized pulmonary rehabilitation programs for COPD patients.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Punjab Province
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Lahore, Punjab Province, Pakistán
- Dr.Sidra Faisal
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Both genders.
- Subjects with the 40-55 age years.
- Diagnosed with COPD
- Subjects who are on regular treatment
- Subjects who are conscious and cooperative
- Subjects who can understand and follow instruction
Exclusion Criteria:
• Patients with recent abdominal, and thoracic surgery.
- Patients with any Disability; Physical or Mental.
- Patients with unstable angina, advanced congestive heart failure, or severe pulmonary hypertension, because altered intrathoracic pressures during forced expirations strain the heart.
- Patients with advanced kyphoscoliosis or severe pectus excavatum, as baseline structural restrictions prevent optimal diaphragmatic excursion and chest wall expansion.
- Patients presenting with severe resting hypoxemia or highly volatile blood oxygen values at baseline that require continuous emergency clinical monitoring.
- Patients who have experienced a sudden worsening or an acute clinical crash within the past 4 weeks, as the forced expiratory components (such as huffing) involved in active airway clearance can severely exacerbate active bronchospasms.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Group A: Active Cycle of Breathing Technique (ACBT)
For Arm 1 (Group A), enter this text into the description field: Active Cycle of Breathing Technique (ACBT) group. Participants in this arm will perform the Active Cycle of Breathing Technique, which combines three phases: breathing control (relaxed breathing), thoracic expansion (deep breaths), and the forced expiratory technique ("huffing") to mobilize and clear mucus from the lungs. The intervention will be administered in 2 sessions per day for a total duration of 8 weeks. Each session will last approximately 15 to 20 minutes. Participants will also receive standard COPD medical care and medication, alongside standard baseline postural drainage. |
The intervention consists of the Active Cycle of Breathing Technique (ACBT), a flexible regimen of breathing exercises designed to clear excess secretions from the lungs.
It will be performed in 3 distinct phases: 1) Breathing Control (relaxed, gentle breathing to calm the airways), 2) Thoracic Expansion (deep, controlled breaths to expand the chest and loosen mucus), and 3) Forced Expiratory Technique/FET (using "huffing" to mobilize and clear mucus).
Participants will perform 2 sessions a day, lasting 15-20 minutes per session, for a total of 8 weeks.
All sessions will be conducted under standard baseline postural drainage alongside standard medical care.
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|
Experimental: Group B: Pursed Lip Breathing Technique (PLB)
Pursed Lip Breathing (PLB) group.
Participants in this arm will perform Pursed Lip Breathing, a technique where they slowly inhale through the nose for 2 counts and gently exhale through puckered lips for 4 or more counts to slow breathing and improve ventilation.
The intervention will be administered in 2 sessions per day for a total duration of 8 weeks.
Each session will last approximately 15 to 20 minutes.
Participants will also receive standard COPD medical care and medication, alongside standard baseline postural drainage.
|
The intervention consists of the Pursed Lip Breathing (PLB) technique, a breathing exercise aimed at reducing breathlessness and improving ventilation efficiency.
Participants are trained to slowly inhale through the nose for 2 counts (allowing the belly to expand) and gently exhale through puckered lips for 4 or more counts without forcing the air out.
Participants will perform 2 sessions a day, lasting 15-20 minutes per session, for a total of 8 weeks.
All sessions will be conducted under standard baseline postural drainage alongside standard medical care.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
orced Expiratory Volume in 1 second (FEV1)
Periodo de tiempo: Baseline and post-intervention at 8 weeks
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Baseline and post-intervention at 8 weeks
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Pulmonary Function Test (FEV1/FVC Ratio)
Periodo de tiempo: Baseline and post-intervention at 8 weeks
|
Baseline and post-intervention at 8 weeks
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- UOL/IREB/25/12/0002
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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