Asthma Bronchiale
Conditions
Keywords
Breathing retraining, Synchronous intervention, telemedicine, digital health, nasal breathing
Brief summary
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.
Interventions
BEHAVIORALVirtual 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.
OTHERUsual Care Group
Standard medical care for asthma according to current guidelines without additional breathing training intervention.
Sponsors
Prof. Dr. Andreas Rembert Koczulla
Cegla Medizintechnik GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Asthma-related quality of life (AQLQ) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Asthma Control | Baseline to 12 weeks (also assessed every 2 weeks) | Change in asthma control measured using the Asthma Control Test (ACT). |
| Change in Dysfunctional Breathing Symptoms | Baseline to 12 weeks | Change in symptoms of dysfunctional breathing measured by the Nijmegen Questionnaire |
| Change in Physiological parameters (wearable-derived) | Baseline to 12 weeks | Heart rate, assessed via wearable device. |
| Change in Physical Performance | Baseline and 12 weeks | Change in physical performance assessed using the 1-minute sit-to-stand test. |
| Participant Satisfaction | At 12 weeks | Participant-reported satisfaction with the intervention measured using a study-specific questionnaire (5-point Likert scale). |
| Number of Treatment-related Adverse Events | Throughout the 12-week study period | Incidence of adverse events including dizziness, discomfort, asthma exacerbations, changes in medication use, and use of rescue medication. |
| Time to Clinically Meaningful Improvement | Assessed every 2 weeks up to 12 weeks | Time to first achievement of a clinically meaningful improvement (≥0.5 points) in AQLQ or ACT. |
| Adherence and Engagement | 12-week intervention period | Attendance at supervised sessions and frequency of home-based breathing exercises (self-reported diary). |
| Change in Psychological outcomes | Baseline to 12 weeks | Changes in anxiety (GAD-7) |
Contacts
CONTACTInga Jarosch, Dr.
Outcome results
None listed