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

NCT07752836 | Not Yet Recruiting

• 1 other identifier: BREATHE
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Asthma Bronchiale

Keywords

Breathing retraining; Synchronous intervention; telemedicine; digital health; nasal breathing

Outcome Measures

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.

  Baseline to 12 weeks

Secondary Outcomes (15)

• Change in Asthma Control

  Baseline to 12 weeks (also assessed every 2 weeks)

• Change in Dysfunctional Breathing Symptoms

  Baseline to 12 weeks

• Change in Physiological parameters (wearable-derived)

  Baseline to 12 weeks

• Change in Physiological parameters (wearable-derived)

  Baseline to 12 weeks

• Change in Physical Performance

  Baseline and 12 weeks

Study Arms (2)

Experimental Group

EXPERIMENTAL

Virtual Breathing Training Program

Behavioral: Virtual Breathing Training Program

Usual Care Group

ACTIVE COMPARATOR

Usual Care

Other: Usual Care Group

Interventions

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.

Experimental Group

Usual Care Group OTHER

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

Usual Care Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Prof. Dr. Andreas Rembert Koczulla: lead
• Cegla Medizintechnik GmbH: collaborator

Central Study Contacts

Inga Jarosch, Dr.

CONTACT

+49 8652 93; ijarosch@schoen-klinik.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of pulmonology, head of institute for pulmonary rehabilitation research

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: August 7, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: August 7, 2026

Record last verified: 2026-05