High-intensity Inspiratory Muscle Training in Patients With Asthma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Maximal inspiratory pressure (MIP) measurement
研究概览
简要总结
The aim of this study is to examine the effects of high-intensity and low-intensity inspiratory muscle training added to the standard pulmonary rehabilitation exercise program including aerobic and peripheral muscle strengthening training on respiratory muscle function, exercise capacity, dyspnea and health-related quality of life in asthmatic patients. The aim of the study was to examine whether there are intra-group changes and inter-group differences in the groups where low and high intensity inspiratory muscle training was applied. The cases meeting the inclusion criteria will be randomized and divided into two groups, the groups will be named as High Intensity Inspiratory Muscle Training Group (H-IMT) and Low Intensity Inspiratory Muscle Training Group (L-IMT).
详细描述
Patients diagnosed with asthma by a chest diseases specialist and referred to pulmonary rehabilitation will be included in the study. The cases meeting the inclusion criteria will be randomized and divided into two groups, the groups will be named as High Intensity Inspiratory Muscle Training Group (H-IMT) and Low Intensity Inspiratory Muscle Training Group (L-IMT). Inspiratory muscle training will be carried out in the form of 2 minutes of work and 1 minute break for a total of 21 minutes, starting from 80% of the maximum inspiratory pressure determined by mouth pressure measurement for the H-IMT Group and 30% for the L-IMT Group. An 8-week training will be carried out by increasing the planned load by 5% every two weeks. In addition, breathing exercises, strengthening exercises and walking training on flat ground will be given to both groups in the form of a home program. The training program will be 8 weeks in total, 3 days a week. will be given online exercises, synchronized 2 days a week, and a home program for 1 day, accompanied by a physiotherapist, via videoconference on the smartphone. A total of 24 sessions will be held.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being between the ages of 18-65 years
- •Having been diagnosed with severe persistent, non-allergic asthma by a pulmonologist in accordance with the Global Initiative for Asthma (GINA) guideline criteria,
- •Patients with type 2 inflammation markers. According to accepted standards; peripheral eosinophils <150/µL and/or negative skin prick test and/or total IgE <30 kU/L
- •Bronchodilator response (>12% or 200 mL improvement in FEV1% predicted following inhalation of 400 mg salbutamol)
- •Those who were diagnosed at least 6 months ago and are under follow-up and treatment, and/or patients whose asthma is under control
排除标准
- •Having recently had a respiratory tract infection recently (within the last month),
- •Having a smoking history of more than 10 pack-years or having a history of smoking within 6 months after quitting smoking
- •Having received oral corticosteroid treatment in the last 4 weeks,
- •Having a Body Mass Index >35,
- •Eosinophilic Granulomatosis Polyangiitis (EGPA) and Allergic Bronchopulmonary Aspergillosis (ABPA),
- •Vasculitis,
- •History of malignancy,
- •Pregnancy,
- •Previous lung surgery, use of long-term oxygen therapy
- •Having accompanying restrictive lung diseases (advanced kyphoscoliosis, ankylosing spondylitis) and neuromuscular diseases (myasthenia gravis, muscular dystrophies, myopathies) that will prevent healthy respiratory function testing and rehabilitation.
- •Having conditions such as cognitive dysfunction, mental retardation, dementia that make it difficult to implement the protocol or interpret the study results
结局指标
主要结局
Maximal inspiratory pressure (MIP) measurement
时间窗: Change from baseline respiratory muscle strength at 8 weeks
Respiratory muscle strength will be assessed via maximal inspiratory pressure (MIP). Tests will be carried out according to American Thoracic Society (ATS) / European Respiratory Society (ERS) criteria.
Six minute walking test
时间窗: Change from baseline 6 minute walking distance at 8 weeks
The exercise capacity will be assessed by the 6-minute walking test. The test will be conducted in a 30-meter corridor in line with American Thoracic Society (ATS) guidelines.
Modified Medical Research Council (mMRC) Dyspnea Scale
时间窗: Change from baseline dyspnea perception at 8 weeks
The Modified Medical Research Council (mMRC) Dyspnea Scale will be used to evaluate the patients' dyspnea levels. The mMRC will consist of a 0-4 point category scale in which the patient will choose the statement that best describes their dyspnea level among 5 statements that express the feeling of difficulty in breathing experienced in daily life activities. A higher score will indicate greater dyspnea severity.
次要结局
- Forced Expiratory Volume (FEV1)(Change from baseline FEV1 at 8 weeks)
- Forced Vital Capacity (FVC)(Change from baseline FVC at 8 weeks)
- Peak Expiratory Flow (PEF)(Change from baseline PEF at 8 weeks])
- FEV1/FVC(Change from baseline FEV1/FVC at 8 weeks])
- Asthma Control Test (ACQ)(Change from baseline ACQ score at 8 weeks)
- Peripheral muscle strength(Change from baseline peripheral muscle strength at 8 weeks)
- Asthma Quality of Life Scale (AQLQ)(Change from baseline AQLQ score at 8 weeks])
- St. George Respiratory Questionnaire (SGRQ)(Change from baseline SGRQ score at 8 weeks)
- International Physical Activity Questionnaire- short form(Change from baseline physical activity level at 8 weeks)
研究者
esra pehlivan
Assoc.Dr.
Istanbul Medipol University Hospital