High-intensity Inspiratory Muscle Training in Patients With Asthma
Recruiting · NCT06516848 · Interventional (participants receive a specific treatment) · Lead sponsor: Istanbul Medipol University Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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).
Who can take part
Inclusion criteria
- 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
Exclusion criteria
- 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
Where it is running
1 location listed.
- Esra Pehli̇van - Istanbul, Üsküdar, Turkey (Türkiye)