- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07717476
Comparison of Box Breathing and Rhythmic Breathing Techniques in Patients With Asthma (BRAS)
Comparative Effects of Box and Rhythmic Breathing Techniques on Dyspnea, Pulmonary Functions, and Quality of Sleep Among Asthmatic Patients
Asthma is a chronic respiratory disease that can cause breathing difficulties, reduced lung function, and poor sleep quality. Breathing exercises are increasingly used as non-pharmacological interventions to improve respiratory symptoms and overall well-being in individuals with asthma.
This study aims to compare the effects of two breathing techniques, Box Breathing and Rhythmic Breathing, on dyspnea (breathlessness), pulmonary function, and quality of sleep in patients with asthma. Participants with asthma will be randomly assigned to receive either Box Breathing or Rhythmic Breathing exercises in addition to standard care. Both interventions will be performed three times per week for eight weeks.
The primary outcomes of this study include changes in dyspnea severity, pulmonary function measured by spirometry, and sleep quality assessed using validated questionnaires. The findings of this study may help determine which breathing technique is more effective and provide evidence for incorporating structured breathing exercises into asthma management programs.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Asthma is a chronic inflammatory airway disease characterized by recurrent episodes of dyspnea, airflow limitation, and impaired quality of life. In addition to respiratory symptoms, many individuals with asthma experience sleep disturbances and reduced functional capacity. Breathing exercises have emerged as important non-pharmacological interventions that may improve respiratory control, autonomic regulation, and symptom perception.
Box Breathing and Rhythmic Breathing are structured breathing techniques that have shown potential benefits in respiratory rehabilitation. Box Breathing involves a controlled breathing pattern consisting of equal durations of inhalation, breath holding, exhalation, and breath holding. Rhythmic Breathing involves continuous and controlled breathing with a prolonged expiratory phase to promote respiratory efficiency and relaxation. However, limited evidence exists regarding the comparative effectiveness of these techniques in individuals with asthma.
The purpose of this study is to compare the effects of Box Breathing and Rhythmic Breathing on dyspnea, pulmonary function, and sleep quality among patients with asthma. Participants will receive standardized baseline respiratory care followed by either Box Breathing or Rhythmic Breathing interventions for eight weeks. The interventions are designed to improve breathing patterns, reduce breathlessness, enhance pulmonary function, and improve sleep quality.
This study aims to provide evidence regarding the effectiveness of structured breathing techniques as adjunctive interventions in asthma management. The findings may contribute to the development of evidence-based respiratory rehabilitation protocols and support the integration of breathing exercises into comprehensive asthma care programs.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Humera Ayub, MS CPPT
- Número de teléfono: +923045938096
- Correo electrónico: humera.ayub@riphah.edu.pk
Ubicaciones de estudio
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistán, 59300
- Ittefaq Hospital and Ghurki Trust Hospital
-
Contacto:
- Humera Ayub, MS CPPT
- Número de teléfono: +923045938096
- Correo electrónico: humera.ayub@riphah.edu.pk
-
Investigador principal:
- Ayesha Sehar, MS-CPPT
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Male and female patients diagnosed with asthma.
- Age between 18 and 40 years.
- Patients with mild to moderate asthma who are clinically stable.
- Patients able to understand and follow breathing exercise instructions.
- Patients willing to provide informed consent and participate in the study.
Exclusion Criteria:
- Patients with severe or uncontrolled asthma.
- Patients with acute asthma exacerbation during the study period.
- Patients with other significant respiratory diseases (e.g., chronic obstructive pulmonary disease, pulmonary fibrosis).
- Patients with severe cardiovascular, neurological, or musculoskeletal disorders that may interfere with participation.
- Patients who are pregnant.
- Patients unable to perform the breathing interventions or complete study assessments.
- Patients participating in another structured respiratory rehabilitation or breathing exercise program.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Box Breathing Group A
Participants assigned to this arm received standardized baseline respiratory care followed by Box Breathing training.
The Box Breathing technique consisted of inhaling for 4 seconds, holding the breath for 4 seconds, exhaling for 4 seconds, and holding the breath again for 4 seconds.
The intervention was performed for 20 minutes per session, three sessions per week, for eight weeks.
Short rest periods were provided as needed during the intervention.
|
Participants assigned to the Box Breathing intervention received a structured breathing exercise protocol following standardized baseline respiratory care.
The Box Breathing technique consisted of inhalation for 4 seconds, breath holding for 4 seconds, exhalation for 4 seconds, and a second breath hold for 4 seconds (4-4-4-4 pattern).
The intervention was administered for 20 minutes per session, three sessions per week, for eight weeks.
Short rest periods were permitted after every 5-6 breathing cycles as needed.
The intervention was performed in a quiet environment and aimed to improve respiratory control, reduce dyspnea, enhance ventilatory efficiency, and promote autonomic regulation.
|
|
Experimental: Rhythmic Breathing Group
Participants assigned to this arm received standardized baseline respiratory care followed by Rhythmic Breathing training.
The Rhythmic Breathing technique consisted of a controlled breathing pattern using a 4:6 ratio, with inhalation through the nose for 4 seconds and exhalation through the mouth for 6 seconds.
The intervention was performed for 20 minutes per session, three sessions per week, for eight weeks.
Short rest periods were provided as needed during the intervention.
|
Participants assigned to the Rhythmic Breathing intervention received a structured breathing exercise protocol following standardized baseline respiratory care.
The Rhythmic Breathing technique consisted of a controlled breathing pattern using a 4:6 ratio, with inhalation through the nose for 4 seconds and exhalation through the mouth for 6 seconds.
The intervention was administered for 20 minutes per session, three sessions per week, for eight weeks.
Short rest periods were provided every 6-7 minutes as needed.
The intervention was designed to promote respiratory efficiency, improve autonomic balance, reduce dyspnea, and enhance pulmonary function and sleep quality.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Dyspnea Severity
Periodo de tiempo: Baseline and 8 weeks (post-intervention)
|
Dyspnea severity will be assessed using the Modified Borg Scale, a numerical rating scale ranging from 0 to 10, where higher scores indicate greater perceived breathlessness.
|
Baseline and 8 weeks (post-intervention)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Pulmonary Function (Forced Expiratory Volume in 1 Second [FEV₁])
Periodo de tiempo: Baseline and 8 weeks (post-intervention)
|
Pulmonary function will be assessed using spirometry.
Forced Expiratory Volume in 1 second (FEV₁) will be used to evaluate changes in lung function following the intervention.
|
Baseline and 8 weeks (post-intervention)
|
|
Sleep Quality
Periodo de tiempo: Baseline and 8 weeks (post-intervention)
|
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), a validated questionnaire measuring subjective sleep quality over the previous month.
Lower scores indicate better sleep quality.
|
Baseline and 8 weeks (post-intervention)
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Humera Ayub, MS-CPPT, Riphah International University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
- Procesos Patológicos
- Enfermedades del sistema inmunológico
- Enfermedades de las vías respiratorias
- Enfermedades pulmonares
- Enfermedades bronquiales
- Enfermedades Pulmonares Obstructivas
- Hipersensibilidad Respiratoria
- Hipersensibilidad, Inmediata
- Hipersensibilidad
- Condiciones Patológicas, Signos y Síntomas
- Asma
- Enfermedad
Otros números de identificación del estudio
- REC/RCR & AHS/25/0315
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan 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.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .