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

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Change in Asthma-related quality of life (AQLQ) [Срок оценки: Baseline to 12 weeks]

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Организация здравоохранения

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07752836 · BREATHE

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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