Virtual Breathing Intervention for Enhancing Asthma-related Quality of Life - A Randomized Controlled Trial (BREATHE)
Effectiveness, Feasibility, and Acceptability of a 12-Week Virtual Breathing Training Program to Improve Disease-Specific Quality of Life in Adults With Asthma and Incomplete Symptom Control: A Randomized Controlled Trial
Asthma is a common long-term lung condition that can cause symptoms such as shortness of breath, chest tightness, and anxiety. Even with appropriate medication, about 30-40% of people with asthma do not achieve good symptom control and continue to experience reduced quality of life.
Breathing exercises are recommended as an additional, non-drug treatment for asthma. However, these programs are not widely available outside of rehabilitation clinics, and more scientific evidence is needed, especially for digital formats.
This study aims to investigate whether a 12-week structured breathing training program delivered online can improve asthma-related quality of life in adults whose asthma is not well controlled. Participants will be randomly assigned to either the intervention group or a control group receiving usual care.
The intervention consists of weekly live, group-based breathing sessions led by trained physiotherapists via videoconference, combined with short daily self-practice exercises at home. Participants will also use a simple breathing device to support the exercises. The control group will continue their usual medical care without additional breathing training.
We will assess whether the program improves quality of life, asthma control, and symptoms such as anxiety, stress, and dysfunctional breathing. The study will also evaluate whether the online format is feasible, acceptable, and satisfactory for participants.
The breathing exercises are non-invasive and low risk. The results of this study may help to develop accessible, low-cost, and evidence-based support programs for people with asthma.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Inga Jarosch, Dr.
- Número de teléfono: 1730 +49 8652 93
- Correo electrónico: ijarosch@schoen-klinik.de
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Adults aged ≥18 years
- Asthma bronchiale
- Partly controlled or uncontrolled asthma according to GINA 2025 criteria
- Access to internet and compatible smartphone for digital intervention and data collection
Exclusion Criteria:
- Clinically relevant nasal obstruction (e.g., severe septal deviation, nasal polyps) affecting nasal breathing
- Current regular use of structured breathing therapy or breathing training devices
- Participation in another interventional clinical trial that may interfere with outcomes
- Severe comorbid conditions limiting participation in mild physical or breathing exercise (e.g., unstable cardiovascular disease)
- Lack of willingness or ability to use required digital tools (video platform, wearable device, smartphone app)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Experimental Group
Virtual Breathing Training Program
|
A 12-week structured, physiotherapist-led breathing training delivered via weekly live video group sessions combined with daily home-based exercises.
The program includes breathing techniques such as nasal breathing, diaphragmatic breathing, and breathing control strategies.
Participants also use a breathing training device to support the exercises.
|
|
Comparador activo: Usual Care Group
Usual Care
|
Standard medical care for asthma according to current guidelines without additional breathing training intervention.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Asthma-related quality of life (AQLQ)
Periodo de tiempo: Baseline to 12 weeks
|
Change in disease-specific quality of life measured using the Asthma Quality of Life Questionnaire (AQLQ).
The AQLQ is a validated instrument for adults with asthma.
Scores range from 1 to 7, with higher scores indicating better quality of life.
A change of 0.5 points is considered clinically meaningful.
|
Baseline to 12 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Asthma Control
Periodo de tiempo: Baseline to 12 weeks (also assessed every 2 weeks)
|
Change in asthma control measured using the Asthma Control Test (ACT).
|
Baseline to 12 weeks (also assessed every 2 weeks)
|
|
Change in Dysfunctional Breathing Symptoms
Periodo de tiempo: Baseline to 12 weeks
|
Change in symptoms of dysfunctional breathing measured by the Nijmegen Questionnaire
|
Baseline to 12 weeks
|
|
Change in Physiological parameters (wearable-derived)
Periodo de tiempo: Baseline to 12 weeks
|
Heart rate, assessed via wearable device.
|
Baseline to 12 weeks
|
|
Change in Physiological parameters (wearable-derived)
Periodo de tiempo: Baseline to 12 weeks
|
Heart rate variability, assessed via wearable device.
|
Baseline to 12 weeks
|
|
Change in Physical Performance
Periodo de tiempo: Baseline and 12 weeks
|
Change in physical performance assessed using the 1-minute sit-to-stand test.
|
Baseline and 12 weeks
|
|
Participant Satisfaction
Periodo de tiempo: At 12 weeks
|
Participant-reported satisfaction with the intervention measured using a study-specific questionnaire (5-point Likert scale).
|
At 12 weeks
|
|
Number of Treatment-related Adverse Events
Periodo de tiempo: Throughout the 12-week study period
|
Incidence of adverse events including dizziness, discomfort, asthma exacerbations, changes in medication use, and use of rescue medication.
|
Throughout the 12-week study period
|
|
Time to Clinically Meaningful Improvement
Periodo de tiempo: Assessed every 2 weeks up to 12 weeks
|
Time to first achievement of a clinically meaningful improvement (≥0.5 points) in AQLQ or ACT.
|
Assessed every 2 weeks up to 12 weeks
|
|
Adherence and Engagement
Periodo de tiempo: 12-week intervention period
|
Attendance at supervised sessions and frequency of home-based breathing exercises (self-reported diary).
|
12-week intervention period
|
|
Change in Psychological outcomes
Periodo de tiempo: Baseline to 12 weeks
|
Changes in anxiety (GAD-7)
|
Baseline to 12 weeks
|
|
Change in Psychological outcomes
Periodo de tiempo: Baseline to 12 weeks
|
Changes in depression (PHQ-9)
|
Baseline to 12 weeks
|
|
Change in Psychological outcomes
Periodo de tiempo: Baseline to 12 weeks
|
Changes in perceived stress (PSS) scores.
|
Baseline to 12 weeks
|
|
Change in Physiological parameters (wearable-derived)
Periodo de tiempo: Baseline to 12 weeks
|
Respiratory rate, assessed via wearable device.
|
Baseline to 12 weeks
|
|
Change in Physiological parameters (wearable-derived)
Periodo de tiempo: Baseline to 12 weeks
|
Sleep duration, assessed via wearable device.
|
Baseline to 12 weeks
|
|
Change in Physiological parameters (wearable-derived)
Periodo de tiempo: Baseline to 12 weeks
|
Daily physical activity (step count), assessed via wearable device.
|
Baseline to 12 weeks
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
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
Otros números de identificación del estudio
- BREATHE
Plan de datos de participantes individuales (IPD)
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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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