NCT Number: NCT07752836
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Standard medical care for asthma according to current guidelines without additional breathing training intervention.
Time frame: 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.
Time frame: Baseline to 12 weeks (also assessed every 2 weeks)
Change in asthma control measured using the Asthma Control Test (ACT).
Time frame: Baseline to 12 weeks
Change in symptoms of dysfunctional breathing measured by the Nijmegen Questionnaire
Time frame: Baseline to 12 weeks
Heart rate, assessed via wearable device.
Time frame: Baseline to 12 weeks
Heart rate variability, assessed via wearable device.
Time frame: Baseline and 12 weeks
Change in physical performance assessed using the 1-minute sit-to-stand test.
Time frame: At 12 weeks
Participant-reported satisfaction with the intervention measured using a study-specific questionnaire (5-point Likert scale).
Time frame: 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 frame: Assessed every 2 weeks up to 12 weeks
Time to first achievement of a clinically meaningful improvement (≥0.5 points) in AQLQ or ACT.
Time frame: 12-week intervention period
Attendance at supervised sessions and frequency of home-based breathing exercises (self-reported diary).
Time frame: Baseline to 12 weeks
Changes in anxiety (GAD-7)
Time frame: Baseline to 12 weeks
Changes in depression (PHQ-9)
Time frame: Baseline to 12 weeks
Changes in perceived stress (PSS) scores.
Time frame: Baseline to 12 weeks
Respiratory rate, assessed via wearable device.
Time frame: Baseline to 12 weeks
Sleep duration, assessed via wearable device.
Time frame: Baseline to 12 weeks
Daily physical activity (step count), assessed via wearable device.
Contact information is provided by the study sponsor or research team.
Prof. Dr. Andreas Rembert Koczulla
Other
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
Acronym: BREATHE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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