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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 110
- 主要终点
- Change in Asthma-related quality of life (AQLQ)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Experimental Group
Virtual Breathing Training Program
干预措施: Virtual Breathing Training Program (Behavioral)
Usual Care Group
Usual Care
干预措施: Usual Care Group (Other)
结局指标
主要结局
Change in Asthma-related quality of life (AQLQ)
时间窗: 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.
次要结局
- 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 Physical Performance(Baseline and 12 weeks)
- Participant Satisfaction(At 12 weeks)
- Number of Treatment-related Adverse Events(Throughout the 12-week study period)
- Time to Clinically Meaningful Improvement(Assessed every 2 weeks up to 12 weeks)
- Adherence and Engagement(12-week intervention period)
- Change in Psychological outcomes(Baseline to 12 weeks)
研究者
Prof. Dr. Andreas Rembert Koczulla
Head of pulmonology, head of institute for pulmonary rehabilitation research
Schön Klinik Berchtesgadener Land