Status:

RECRUITING

High-intensity Inspiratory Muscle Training in Patients With Asthma

Lead Sponsor:

Istanbul Medipol University Hospital

Conditions:

Asthma

Eligibility:

All Genders

18-65 years

Phase:

NA

Brief Summary

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 pe...

Detailed Description

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 di...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

July 23 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

August 1 2025

Estimated Enrollment :

34 Patients enrolled

Trial Details

Trial ID

NCT06516848

Start Date

July 23 2024

End Date

August 1 2025

Last Update

August 9 2024

Active Locations (1)

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1

Esra Pehli̇van

Istanbul, Üsküdar, Turkey (Türkiye), 34668

High-intensity Inspiratory Muscle Training in Patients With Asthma | DecenTrialz