Effect of Intermittent Intrapulmonary Deflation on the Sensory Dimension of Dyspnea After Exercise in Patients With Chronic Obstructive Pulmonary Disease: A Double-blind, Randomized Crossover Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Sensory dimension of dyspnea
研究概览
简要总结
Chronic obstructive pulmonary disease is a long-term lung condition that causes breathing difficulties. People living with this disease often feel short of breath, especially during physical activity, which can make daily tasks more challenging. This breathlessness is partly caused by mucus accumulation within the airways and air getting trapped in the lungs. Both of these reduce the amount of fresh air that can enter with each breath and increase the effort required to breathe.
To manage symptoms, people with chronic obstructive pulmonary disease may use medications, oxygen therapy, or be referred to pulmonary rehabilitation programs. These programs often include exercise training, self-management strategies, and airway clearance techniques. While chest physiotherapists typically guide patients in these techniques, certain medical devices can also help individuals manage their condition independently at home.
One such device uses a method called intermittent intrapulmonary deflation, which involves applying gentle pressure changes through a mouthpiece to help loosen mucus and release trapped air from the lungs. Although some individuals already use this kind of device as part of their daily care, more scientific evidence is needed to determine whether the improvements in airway clearance and reduced air trapping actually lead to measurable relief of breathlessness.
The goal of this clinical trial is to find out whether this type of medical device designed to remove airway mucus and trapped air in the lungs (using intermittent intrapulmonary deflation) can help reduce breathlessness (dyspnea) after physical activity in people with COPD.
The main questions this study aims to answer are:
- Does using the device at home for one week reduce the intensity of breathlessness after walking?
- Does it also improve walking distance, reduce the feeling of muscle fatigue, or increase satisfaction with the airway clearance method?
Researchers will compare the active device to a placebo device that looks and feels identical but does not deliver the active treatment. This comparison will help determine whether the observed effects are due to the device itself or other factors such as expectations or chance.
Participants in this study will be adults diagnosed with moderate to very severe chronic obstructive pulmonary disease. All participants must have recently completed a pulmonary rehabilitation program, continue to experience breathlessness while walking, and show signs of lung hyperinflation (when air remains trapped in the lungs). People will not be included if they have other serious health conditions that could make walking difficult or unsafe, or if they have any contraindications to using the device.
Participants who agree to participante in the study will:
- Attend a visit at the pulmonary rehabilitation center for baseline testing and to learn how to use the device;
- Be randomly assigned to use either the active device or the placebo device at home for 7 days;
- Return to the center for walking tests, lung function tests, and questionnaires about breathing and fatigue;
- After a one-week break, use the device with alternative settings (the one not used in the first phase) for another 7 days;
- Complete a final visit at the end of the study to repeat the same tests.
Participants will also be invited to take part in an ancillary study during their first clinic visit to examine how a single session with the device affects breathlessness immediately after walking.
This research will help determine whether this non-pharmacological, device-based method of clearing mucus and reducing trapped air can bring meaningful improvement in breathlessness for people with chronic obstructive pulmonary disease, especially when used at home. If effective, it may offer a simple and convenient way to help people breathe more comfortably during everyday activities.
Participants will receive compensation for their time and travel.
详细描述
Dyspnea in chronic obstructive pulmonary disease is multifactorial and results from complex pathophysiological mechanisms. A key contributor is dynamic hyperinflation, caused by airflow obstruction and expiratory airway collapse during exertion. Excessive mucus production and impaired mucociliary clearance further contribute to airway obstruction, yet mucus management remains an underexplored therapeutic target.
Current airway clearance techniques, such as manual chest physiotherapy and positive expiratory pressure devices, often require forced expiration and primarily act on proximal airways. In contrast, intermittent intrapulmonary deflation is a novel approach applying intermittent negative pressure during expiration to facilitate secretion mobilization, potentially improving expiratory flow and reducing lung hyperinflation. Intermittent intrapulmonary deflation is active only during passive exhalation, can be self-administered at home, and may provide an alternative for patients chronic pulmonary disease who experience chronic mucus retention.
This study aims to assess the effect of intermittent intrapulmonary deflation on dyspnea after exercise in individuals with chronic obstructive pulmonary disease. By improving secretion clearance and reducing dynamic hyperinflation, intermittent intrapulmonary deflation could represent a novel strategy to alleviate dyspnea, enhance exercise tolerance, quality of life, and address a significant unmet clinical need in this population.
Primary objective: to evaluate the effect of using an intermittent intrapulmonary deflation device for one week at home on the sensory dimension of dyspnea after exercise in individuals with chronic obstructive pulmonary disease.
Secondary objectives: to evaluate the effect of using an intermittent intrapulmonary deflation device for one week at home on exercise capacity, dyspnea perception (affective dimension and dyspnea intensity), perception of lower limb muscle fatigue, breathing pattern, operational lung volume, critical inspiratory constraints, and heart rate measured at the end of exercise. Additionally, the study aims to assess the depth of oxygen desaturation during exercise, participant satisfaction, respiratory function, and adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Statistician.
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
- •Age > 18 years;
- •COPD stage GOLD II to IV;
- •Had completed a pulmonary rehabilitation programme at the investigational site;
- •6-minute walk test < 350 meters before and/or after completing the pulmonary; rehabilitation program;
- •mMRC dyspnea scale ≥ 2;
- •Pulmonary hyperinflation (ratio between residual volume to total lung capacity superior to 50%, and either total lung capacity superior to 130% or functional residual capacity superior to 130%);
- •With or without oxygen supplementation;
- •Stable condition (no exacerbation or change in treatment in the last 4 weeks);
- •Naïve to intermittent intrapulmonary deflation.
- •Regulatory criteria (social security affiliation; adult patient who has read and understood the information letter and signed the informed consent form).
- •Non-inclusion Criteria:
- •Pregnant women or likely to be;
- •Patients under guardianship or curatorship;
- •Inability to consent;
- •Primary diagnosis of another chronic obstructive respiratory disease such as asthma or primary bronchiectasis;
- •Orthopedic, neurological, vascular, or neuromuscular conditions that limit walking or require walking aids;
- •Severe or unstable cardiovascular disease (uncontrolled cardiac arrhythmias, severe heart failure, recent myocardial infarction, unstable angina);
- •Patients actively requiring assistance with inspiration (e.g. ventilatory assistance with endotracheal tube, tracheostomy tube, or ventilated with a mask; patients with neuromuscular disease with respiratory muscle weakness; patients with inability to cough forcefully and independently);
- •Hemodynamic instability;
- •Recent pneumothorax (within the last 3 months);
- •Recent pulmonary or upper airway surgery (within the last month);
- •Referral to a pulmonary rehabilitation program in preparation for thoracic surgery (lung volume reduction, lung transplantation, or lung resection for non-small cell lung cancer);
- •Use of an electrical mechanical device for airway clearance during the study period (in-exsufflator, high-frequency chest oscillation, etc.);
- •Active cancer;
- •Severe episode of hemoptysis in the last 3 months;
- •Severe tracheomalacia.
排除标准
- •Withdrawal of consent;
- •Acute COPD exacerbation between visits or onset of cardiorespiratory instability;
- •Use of an electrical mechanical device for airway clearance during the study period (in-exsufflator, high-frequency chest oscillation, etc.).
研究组 & 干预措施
Active intermittent intrapulmonary deflation
One week home-based treatment period.
干预措施: Active intermittent intrapulmonary deflation. (Device)
Placebo intermittent intrapulmonary deflation
One week home-based treatment period.
干预措施: Placebo intermittent intrapulmonary deflation. (Device)
结局指标
主要结局
Sensory dimension of dyspnea
时间窗: Day 8 (after seven days of intervention)
The sensory dimension of dyspnea will be assessed using French version of the Multidimensional Dyspnea Profile questionnaire, taking into account the last 30 seconds of effort during the 6-minute walk test to complete the questionnaire. This self-administered questionnaire can yield scores ranging from 0 to 10, with higher scores indicating a greater sensory dimension of dyspnea. The established minimal clinically important difference for this outcome is 2 points.
次要结局
- Functional exercise capacity - Six-minute walk test(During visit 1 (day 1).)
- Affective dimension of dyspnea(During visit 1 (day 1).)
- Intensity of dyspnea(During visit 1 (day 1).)
- Intensity of lower limb fatigue(During visit 1 (day 1).)
- Respiratory function - Forced expiratory volume in 1 second(During visit 1 (day 1).)
- Respiratory function - Vital capacity(During visit 1 (day 1).)
- Respiratory function - Forced vital capacity(During visit 1 (day 1).)
- Respiratory function - Ratio between forced expiratory volume in 1 second to forced vital capacity(During visit 1 (day 1).)
- Respiratory function - Functional residual capacity(During visit 1 (day 1).)
- Respiratory function - Total lung capacity(During visit 1 (day 1).)
- Respiratory function - Residual volume(During visit 1 (day 1).)
- Respiratory function - Airway resistance(During visit 1 (day 1).)
- Breathing pattern - Tidal volume(During visit 1 (day 1).)
- Breathing pattern - Respiratory rate(During visit 1 (day 1).)
- Breathing pattern - Inspiratory time(During visit 1 (day 1).)
- Breathing pattern - Expiratory time(During visit 1 (day 1).)
- Breathing pattern - Ratio between inspiratory time to expiratory time(During visit 1 (day 1).)
- Breathing pattern - Minute ventilation(During visit 1 (day 1).)
- Operational lung volume - Inspiratory capacity(During visit 1 (day 1).)
- Operational lung volume - End inspiratory lung volume(During visit 1 (day 1).)
- Health related quality of life(Day 8 (after seven days of intervention).)
- Operational lung volume - End expiratory lung volume(During visit 1 (day 1).)
- Weight of secretions(During visit 1 (day 1).)
- Critical inspiratory constraints - Ratio between tidal volume to inspiratory capacity(During visit 1 (day 1).)
- Critical inspiratory constraints - Ratio between tidal volume to vital capacity(During visit 1 (day 1).)
- Critical inspiratory constraints - Inspiratory reserve volume(During visit 1 (day 1).)
- Critical inspiratory constraints - Ratio between inspiratory reserve volume to total lung capacity(During visit 1 (day 1).)
- Transcutaneous oxygen saturation during a six-minute walk test(During visit 1 (day 1).)
- Heart rate during the six-minute walk test(During visit 1 (day 1).)
- Patient satisfaction(During visit 1 (day 1).)
- Health status(Day 8 (after seven days of intervention).)
- Use of the intermittent intrapulmonary deflation device(Day 8 (after seven days of intervention).)
- Adverse events(Day 8 (after seven days of intervention).)
- Volume of secretions(During visit 1 (day 1).)
- Sensory dimension of dyspnea(During visit 1 (day 1).)
- Operational lung volume - Inspiratory capacity(Day 8 (after seven days of intervention).)
- Functional exercise capacity - Six-minute walk test(Day 8 (after seven days of intervention).)
- Affective dimension of dyspnea(Day 8 (after seven days of intervention).)
- Intensity of dyspnea(Day 8 (after seven days of intervention).)
- Intensity of lower limb fatigue(Day 8 (after seven days of intervention).)
- Respiratory function - Forced expiratory volume in 1 second(Day 8 (after seven days of intervention).)
- Respiratory function - Vital capacity(Day 8 (after seven days of intervention).)
- Respiratory function - Forced vital capacity(Day 8 (after seven days of intervention).)
- Respiratory function - Ratio between forced expiratory volume in 1 second to forced vital capacity(Day 8 (after seven days of intervention).)
- Critical inspiratory constraints - Ratio between tidal volume to inspiratory capacity(Day 8 (after seven days of intervention).)
- Respiratory function - Functional residual capacity(Day 8 (after seven days of intervention).)
- Respiratory function - Total lung capacity(Day 8 (after seven days of intervention).)
- Respiratory function - Residual volume(Day 8 (after seven days of intervention).)
- Respiratory function - Airway resistance(Day 8 (after seven days of intervention).)
- Critical inspiratory constraints - Ratio between tidal volume to vital capacity(Day 8 (after seven days of intervention).)
- Breathing pattern - Tidal volume(Day 8 (after seven days of intervention).)
- Breathing pattern - Respiratory rate(Day 8 (after seven days of intervention).)
- Breathing pattern - Inspiratory time(Day 8 (after seven days of intervention).)
- Breathing pattern - Expiratory time(Day 8 (after seven days of intervention).)
- Breathing pattern - Ratio between inspiratory time to expiratory time(Day 8 (after seven days of intervention).)
- Breathing pattern - Minute ventilation(Day 8 (after seven days of intervention).)
- Operational lung volume - End inspiratory lung volume(Day 8 (after seven days of intervention).)
- Operational lung volume - End expiratory lung volume(Day 8 (after seven days of intervention).)
- Critical inspiratory constraints - Inspiratory reserve volume(Day 8 (after seven days of intervention).)
- Critical inspiratory constraints - Ratio between inspiratory reserve volume to total lung capacity(Day 8 (after seven days of intervention).)
- Transcutaneous oxygen saturation during a six-minute walk test(Day 8 (after seven days of intervention).)
- Heart rate during the six-minute walk test(Day 8 (after seven days of intervention).)
- Patient satisfaction(Day 8 (after seven days of intervention).)