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High-intensity Inspiratory Muscle Training in Patients With Asthma

M

Medipol Health Group

Status

Enrolling

Conditions

Asthma

Treatments

Other: Low Intensity Inspiratory Muscle Training Group (L-IMT)
Other: High Intensity Inspiratory Muscle Training Group (H-IMT)

Study type

Interventional

Funder types

Other

Identifiers

NCT06516848
Asthma_IMT

Details and patient eligibility

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).

Full 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 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.

Enrollment

34 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

34 participants in 2 patient groups

High Intensity Inspiratory Muscle Training Group (H-IMT)
Experimental group
Treatment:
Other: High Intensity Inspiratory Muscle Training Group (H-IMT)
Low Intensity Inspiratory Muscle Training Group (L-IMT)
Experimental group
Treatment:
Other: Low Intensity Inspiratory Muscle Training Group (L-IMT)

Trial contacts and locations

1

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Central trial contact

Cahidenur Koçak

Data sourced from clinicaltrials.gov

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