Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT06516848

High-intensity Inspiratory Muscle Training in Patients With Asthma

Led by Istanbul Medipol University Hospital · Updated on 2024-08-09

34

Participants Needed

1

Research Sites

53 weeks

Total Duration

On this page

AI-Summary

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).

CONDITIONS

Official Title

High-intensity Inspiratory Muscle Training in Patients With Asthma

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Between 18 and 65 years old
  • Diagnosed with severe persistent, non-allergic asthma by a pulmonologist according to GINA guidelines
  • Presence of type 2 inflammation markers such as peripheral eosinophils <150/µL and/or negative skin prick test and/or total IgE <30 kU/L
  • Bronchodilator response defined as >12% or 200 mL improvement in FEV1% predicted after 400 mg salbutamol
  • Diagnosis made at least 6 months ago and asthma is under control or follow-up
Not Eligible

You will not qualify if you...

  • Respiratory tract infection within the last month
  • Smoking history of more than 10 pack-years or smoking within 6 months after quitting
  • Oral corticosteroid treatment within the last 4 weeks
  • Body Mass Index greater than 35
  • Diagnosis of Eosinophilic Granulomatosis Polyangiitis or Allergic Bronchopulmonary Aspergillosis
  • Presence of vasculitis
  • History of malignancy
  • Pregnancy
  • Previous lung surgery or long-term oxygen therapy use
  • Presence of restrictive lung diseases or neuromuscular diseases that impair respiratory testing and rehabilitation
  • Cognitive dysfunction, mental retardation, or dementia preventing protocol adherence or result interpretation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Esra Pehli̇van

Istanbul, Üsküdar, Turkey (Türkiye), 34668

Actively Recruiting

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Research Team

C

Cahidenur Koçak

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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