High-intensity Inspiratory Muscle Training in Patients With Asthma

August 8, 2024 updated by: esra pehlivan, Istanbul Medipol University Hospital
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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Estimated)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High Intensity Inspiratory Muscle Training Group (H-IMT)
Other: 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.
Experimental: Low Intensity Inspiratory Muscle Training Group (L-IMT)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Six minute walking test
Time Frame: Change from baseline 6 minute walking distance at 8 weeks
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
Time Frame: Change from baseline dyspnea perception at 8 weeks
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
Maximal inspiratory pressure (MIP) measurement
Time Frame: Change from baseline respiratory muscle strength at 8 weeks
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Forced Vital Capacity (FVC)
Time Frame: Change from baseline FVC at 8 weeks
Pulmonary function test will be performed using the Pony Fx spirometry device, according to the American Thoracic Society (ATS) guidelines. FVC is the volume of air that can forcibly be blown out after full inspiration.
Change from baseline FVC at 8 weeks
Forced Expiratory Volume (FEV1)
Time Frame: Change from baseline FEV1 at 8 weeks
Change in Forced Expiratory Volume (FEV1) will be measured using spirometry as the maximal volume of air (liters) exhaled in the first second of expiration.
Change from baseline FEV1 at 8 weeks
Peak Expiratory Flow (PEF)
Time Frame: Change from baseline PEF at 8 weeks]
Change in Peak Expiratory Flow (PEF) will be measured using spirometry as the maximal speed of expiration (measured in liters/min).
Change from baseline PEF at 8 weeks]
FEV1/FVC
Time Frame: Change from baseline FEV1/FVC at 8 weeks]
Spirometry will be used to measure the values of FEV1/FVC three times. The highest result will be recorded.
Change from baseline FEV1/FVC at 8 weeks]
Asthma Control Test (ACQ)
Time Frame: Change from baseline ACQ score at 8 weeks
The ACQ will be a test that allows subjective evaluation of the last 4 weeks of disease control in asthma patients. The ACQ will consist of 5 items that the patient can complete themselves. Each item will be scored between 1 and 5. An ACQ score of 25 will indicate "controlled" asthma, a score between 20 and 24 will indicate "partially controlled" asthma, and a score <20 will indicate "uncontrolled" asthma.
Change from baseline ACQ score at 8 weeks
Peripheral muscle strength
Time Frame: Change from baseline peripheral muscle strength at 8 weeks
Peripheral muscle strength will be assessed by a hand-held dynamometer.
Change from baseline peripheral muscle strength at 8 weeks
Asthma Quality of Life Scale (AQLQ)
Time Frame: Change from baseline AQLQ score at 8 weeks]
This survey will consist of 32 questions in four disease-specific health areas. The AQLQ will include 12 questions about symptoms, 11 questions about limitations in activities, 5 questions about emotional state, and 4 questions about environmental stimuli. Patients will be asked to respond to each item on a 7-point scale (1: Severe impairment, 7: No impairment) considering their quality of life in the last two weeks. The total score average and average scores for sub-dimensions will be calculated. The average of the obtained values will be evaluated between 1 and 7.
Change from baseline AQLQ score at 8 weeks]
St. George Respiratory Questionnaire (SGRQ)
Time Frame: Change from baseline SGRQ score at 8 weeks
This will be a self-administered questionnaire that can be completed by the patient to determine disease-specific quality of life. The test will consist of 50 items divided into 3 parts measuring the symptoms of the disease, activity limitation, and social/emotional impact. The activity component will relate to physical activities that may cause or are limited by shortness of breath. The impact component will include factors such as work, occupation, medications taken to keep one's health under control, side effects of medications, difficulty in continuing daily life activities, and panic. The three parts of the test will be scored separately and the total score will be calculated. St. George Respiratory Questionnaire scores will range from 0 (no impairment in quality of life) to 100 (poor quality of life). In the SGRQ questionnaire, a change of four units due to treatment will be considered significant.
Change from baseline SGRQ score at 8 weeks
International Physical Activity Questionnaire- short form
Time Frame: Change from baseline physical activity level at 8 weeks
Physical activity level will be assessed by the International Physical Activity Questionnaire - Short Form. This will include seven questions on the frequency and duration of time spent in physical activity in the past 7 days to calculate a score for each domain (walking, moderate-intensity activities, and vigorous-intensity activities) and an overall grand total expressed in MET-minutes/week. MET values and formula for computation of MET-minutes: Walking MET-minutes/week = 3.3 * walking minutes * walking days; Moderate MET-minutes/week = 4.0 * moderate-intensity activity minutes * moderate days; Vigorous MET-minutes/week = 8.0 * vigorous-intensity activity minutes * vigorous-intensity days. A combined total physical activity MET-min/week will be computed as the sum of Walking + Moderate + Vigorous MET-min/week scores.
Change from baseline physical activity level at 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Medipol University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 23, 2024

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

July 4, 2024

First Submitted That Met QC Criteria

July 23, 2024

First Posted (Actual)

July 24, 2024

Study Record Updates

Last Update Posted (Actual)

August 9, 2024

Last Update Submitted That Met QC Criteria

August 8, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Asthma_IMT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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