Virtual Breathing Intervention for Enhancing Asthma-related Quality of Life - A Randomized Controlled Trial

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorProf. Dr. Andreas Rembert Koczulla

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Virtual Breathing Training Program

    Behavioral

    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.

  • Usual Care Group

    Other intervention

    Standard medical care for asthma according to current guidelines without additional breathing training intervention.

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: Experimental GroupExperimental treatment 1 intervention
Group B: Usual Care GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Asthma-related quality of life (AQLQ)

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

Secondary outcomes

1

Change in Asthma Control

Change in asthma control measured using the Asthma Control Test (ACT).

Time frame
Baseline to 12 weeks (also assessed every 2 weeks)
2

Change in Dysfunctional Breathing Symptoms

Change in symptoms of dysfunctional breathing measured by the Nijmegen Questionnaire

Time frame
Baseline to 12 weeks
3

Change in Physiological parameters (wearable-derived)

Heart rate, assessed via wearable device.

Time frame
Baseline to 12 weeks
4

Change in Physiological parameters (wearable-derived)

Heart rate variability, assessed via wearable device.

Time frame
Baseline to 12 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Prof. Dr. Andreas Rembert Koczulla

Lead sponsor

Schön Klinik Berchtesgadener Land

Sponsor institution

Cegla Medizintechnik GmbH

Collaborator

This trial is not recruiting at the moment. You can still explore other options: