High-intensity Inspiratory Muscle Training in Patients With Asthma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-23

Study Completion Date

2025-08-01

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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High Intensity Inspiratory Muscle Training Group (H-IMT)

Group Type EXPERIMENTAL

High Intensity Inspiratory Muscle Training Group (H-IMT)

Intervention Type 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.

Low Intensity Inspiratory Muscle Training Group (L-IMT)

Group Type EXPERIMENTAL

Low Intensity Inspiratory Muscle Training Group (L-IMT)

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No