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RECRUITINGINTERVENTIONAL

High-intensity Inspiratory Muscle Training in Patients With Asthma

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

OTHER

High Intensity Inspiratory Muscle Training Group (H-IMT)

Respiratory muscle strengthening training will be given with a resistive threshold inspiratory muscle strengthening device. Initially, it will be worked out vigorously at 80% of the maximum inspiratory pressure determined by mouth pressure measurement. The load will be increased weekly.

OTHER

Low Intensity Inspiratory Muscle Training Group (L-IMT)

Respiratory muscle strengthening training will be given with a resistive threshold inspiratory muscle strengthening device. Initially, it will be worked out vigorously at 30% of the maximum inspiratory pressure determined by mouth pressure measurement. The load will be increased weekly.

Locations (1)

Esra Pehli̇van
Istanbul, Üsküdar, Turkey (Türkiye)