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Not yet recruiting NCT07752836

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

No phase Interventional Asthma Bronchiale

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Virtual Breathing Training Program, Usual Care Group.
Who it may be relevant to
Registry conditions: Asthma Bronchiale. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • Behavioral 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.
  • Other Usual Care Group
    Standard medical care for asthma according to current guidelines without additional breathing training intervention.

Primary outcome measures

  • Change in Asthma-related quality of life (AQLQ) [Time frame: Baseline to 12 weeks]
Secondary outcome measures (12)
  • Change in Asthma Control [Time frame: Baseline to 12 weeks (also assessed every 2 weeks)]
  • Change in Dysfunctional Breathing Symptoms [Time frame: Baseline to 12 weeks]
  • Change in Physiological parameters (wearable-derived) [Time frame: Baseline to 12 weeks]
  • Change in Physiological parameters (wearable-derived) [Time frame: Baseline to 12 weeks]
  • Change in Physical Performance [Time frame: Baseline and 12 weeks]
  • Participant Satisfaction [Time frame: At 12 weeks]
  • Number of Treatment-related Adverse Events [Time frame: Throughout the 12-week study period]
  • Time to Clinically Meaningful Improvement [Time frame: Assessed every 2 weeks up to 12 weeks]
  • Adherence and Engagement [Time frame: 12-week intervention period]
  • Change in Psychological outcomes [Time frame: Baseline to 12 weeks]
  • Change in Psychological outcomes [Time frame: Baseline to 12 weeks]
  • Change in Psychological outcomes [Time frame: Baseline to 12 weeks]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Health services research

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07752836 · BREATHE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗