High-intensity Inspiratory Muscle Training in Patients With Asthma

NCT06516848 | Recruiting

• 1 other identifier: Asthma_IMT
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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 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

Asthma

Keywords

inspiratory muscle training; exercises

Outcome Measures

Primary Outcomes (3)

• Maximal inspiratory pressure (MIP) measurement

  Respiratory muscle strength will be assessed via maximal inspiratory pressure (MIP). Tests will be carried out according to American Thoracic Society (ATS) / European Respiratory Society (ERS) criteria.

  Change from baseline respiratory muscle strength at 8 weeks

• Six minute walking test

  The exercise capacity will be assessed by the 6-minute walking test. The test will be conducted in a 30-meter corridor in line with American Thoracic Society (ATS) guidelines.

  Change from baseline 6 minute walking distance at 8 weeks

• Modified Medical Research Council (mMRC) Dyspnea Scale

  The Modified Medical Research Council (mMRC) Dyspnea Scale will be used to evaluate the patients' dyspnea levels. The mMRC will consist of a 0-4 point category scale in which the patient will choose the statement that best describes their dyspnea level among 5 statements that express the feeling of difficulty in breathing experienced in daily life activities. A higher score will indicate greater dyspnea severity.

  Change from baseline dyspnea perception at 8 weeks

Secondary Outcomes (9)

• Forced Vital Capacity (FVC)

  Change from baseline FVC at 8 weeks

• Forced Expiratory Volume (FEV1)

  Change from baseline FEV1 at 8 weeks

• Peak Expiratory Flow (PEF)

  Change from baseline PEF at 8 weeks]

• FEV1/FVC

  Change from baseline FEV1/FVC at 8 weeks]

• Asthma Control Test (ACQ)

  Change from baseline ACQ score at 8 weeks

Study Arms (2)

High Intensity Inspiratory Muscle Training Group (H-IMT)

EXPERIMENTAL

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

Low Intensity Inspiratory Muscle Training Group (L-IMT)

EXPERIMENTAL

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

Interventions

High Intensity Inspiratory Muscle Training Group (H-IMT) OTHER

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.

High Intensity Inspiratory Muscle Training Group (H-IMT)

Low Intensity Inspiratory Muscle Training Group (L-IMT) OTHER

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.

Low Intensity Inspiratory Muscle Training Group (L-IMT)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Esra Pehli̇van

Istanbul, Üsküdar, 34668, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• Kocak C, Pehlivan E, Baslilar S. High- vs. low-intensity inspiratory muscle training in asthma: effects on respiratory muscles, exercise performance, dyspnea, and health-related quality of life. J Asthma. 2025 Oct;62(10):1776-1788. doi: 10.1080/02770903.2025.2519103. Epub 2025 Jun 20.

  PMID: 40524414 DERIVED

MeSH Terms

Conditions

Asthma; Motor Activity

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Behavior

Central Study Contacts

Cahidenur Koçak

CONTACT

+90 216 777 8 777; cahidekocak@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc.Dr.

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: July 4, 2024
• First Posted: July 24, 2024
• Study Start: July 23, 2024
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: August 9, 2024

Record last verified: 2024-08

Locations

TU (1)