AsthmaNCT06516848
High-intensity Inspiratory Muscle Training in Patients With Asthma
A study testing High Intensity Inspiratory Muscle Training Group (H-IMT) and Low Intensity Inspiratory Muscle Training Group (L-IMT) in people with Asthma, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- High Intensity Inspiratory Muscle Training Group (H-IMT) and Low Intensity Inspiratory Muscle Training Group (L-IMT)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Jul 2024to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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,
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Esra Pehli̇van
Istanbul, Üsküdar, 34668
Esra Pehli̇van, 0216777 87 77, fztesrakambur@yahoo.com
Cahidenur Koçak, cahidekocak@gmail.com
About this study
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).
Read the 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.
- Conditions
- Asthma
- Being tested
- High Intensity Inspiratory Muscle Training Group (H-IMT), Low Intensity Inspiratory Muscle Training Group (L-IMT)
- Keywords
- inspiratory muscle training, exercises
- Medical subject headings
- Asthma, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Inspiratory Muscle Training Group (H-IMT) | Experimental | Not described Receives: Other: High Intensity Inspiratory Muscle Training Group (H-IMT) |
| Low Intensity Inspiratory Muscle Training Group (L-IMT) | Experimental | Not described Receives: Other: Low Intensity Inspiratory Muscle Training Group (L-IMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Change from baseline dyspnea perception at 8 weeks
Secondary outcomes (9)
Forced Vital Capacity (FVC)
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.
Measured: Change from baseline FVC at 8 weeks
Forced Expiratory Volume (FEV1)
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.
Measured: Change from baseline FEV1 at 8 weeks
Peak Expiratory Flow (PEF)
Change in Peak Expiratory Flow (PEF) will be measured using spirometry as the maximal speed of expiration (measured in liters/min).
Measured: Change from baseline PEF at 8 weeks]
FEV1/FVC
Spirometry will be used to measure the values of FEV1/FVC three times. The highest result will be recorded.
Measured: Change from baseline FEV1/FVC at 8 weeks]
Asthma Control Test (ACQ)
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.
Measured: Change from baseline ACQ score at 8 weeks
Peripheral muscle strength
Peripheral muscle strength will be assessed by a hand-held dynamometer.
Measured: Change from baseline peripheral muscle strength at 8 weeks
Asthma Quality of Life Scale (AQLQ)
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.
Measured: Change from baseline AQLQ score at 8 weeks]
St. George Respiratory Questionnaire (SGRQ)
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.
Measured: Change from baseline SGRQ score at 8 weeks
International Physical Activity Questionnaire- short form
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.
Measured: Change from baseline physical activity level at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start23 Jul 2024
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, esra pehlivan, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06516848
- Sponsor's protocol ID
- Asthma_IMT
- Status last verified
- Aug 2024
- First submitted
- 4 Jul 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40524414
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-intensity Inspiratory Muscle Training in Patients With Asthma
- ClinicalTrials.gov ID
- NCT06516848
- Acronym / sponsor ID
- Asthma_IMT
- Conditions
- Asthma
- Keywords
- inspiratory muscle training, exercises
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 23 Jul 2024 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 24 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | High Intensity Inspiratory Muscle Training Group (H-IMT) |
| 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. | Other | Low Intensity Inspiratory Muscle Training Group (L-IMT) |
Primary outcome
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.
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.
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.
9 secondary outcomes
Forced Vital Capacity (FVC)
Time frame: Change from baseline FVC at 8 weeks
Forced Expiratory Volume (FEV1)
Time frame: Change from baseline FEV1 at 8 weeks
Peak Expiratory Flow (PEF)
Time frame: Change from baseline PEF at 8 weeks]
FEV1/FVC
Time frame: Change from baseline FEV1/FVC at 8 weeks]
Asthma Control Test (ACQ)
Time frame: Change from baseline ACQ score at 8 weeks
Peripheral muscle strength
Time frame: 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]
St. George Respiratory Questionnaire (SGRQ)
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Derived from this study: PubMed 40524414Kocak 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity Inspiratory Muscle Training Group (H-IMT) and Low Intensity Inspiratory Muscle Training Group (L-IMT) in people with Asthma, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cahidenur Koçak (+90 216 777 8 777, cahidekocak@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal inspiratory pressure (MIP) measurement (time frame: Change from baseline respiratory muscle strength at 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06516848, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.