Chronic Obstructive Pulmonary Disease (COPD)DIMS-PREDNCT07598292
Predicting Dynamic Inspiratory Muscle Strength in COPD and Asthma Patients
An observational study of Chronic Obstructive Pulmonary Disease (COPD) and Asthma, run by Hitit University at 1 site in Turkey (Türkiye).
Trial summary
This observational study evaluates whether dynamic inspiratory muscle strength can be estimated in patients with chronic obstructive pulmonary disease (COPD) and asthma using simple clinical and performance-based measurements. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD), Asthma
- How many people
- 123 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Feb 2026to 27 Mar 2026
- Phase
- Observational
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: The study population consisted of adult male patients with a clinical diagnosis of chronic obstructive pulmonary disease or asthma who were recruited from clinical units of Çorum Erol Olçok Training and Research Hospital, Hitit University, Türkiye. Eligible patients were enrolled during the study period if they were able to perform the respiratory muscle and pulmonary function measurements with correct technique and provided written informed consent.
Who may be able to join
- Being 18 years of age or older
- Having a clinical diagnosis of chronic obstructive pulmonary disease or asthma
- Being able to perform fixed-pressure inspiratory muscle loading and S-Index measurements in accordance with the instructions and with correct technique
- Having experienced no additional clinical condition within the previous 12 weeks, apart from the existing chronic respiratory disease, that could acutely affect respiratory function
- Having signed the informed consent form approved by the ethics committee
Who cannot join
- Smoking
- Inability to perform fixed-pressure inspiratory muscle loading or dynamic respiratory muscle strength assessment according to the technical requirements of the measurement protocols
- Inability to obtain reliable data due to insufficient coordination, motivation, or volitional effort
- Presence of a musculoskeletal injury or surgical history affecting the diaphragm, thorax, spine, or abdominal region that could significantly impair respiratory mechanics
- Presence of neurological conditions that may affect respiratory muscle function, such as neuromuscular diseases, peripheral nerve damage, or central nervous system disorders
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hitit University Çorum Erol Olçok Training and Research Hospital
Çorum
About this study
Official title: Prediction Models for Dynamic Respiratory Muscle Strength in COPD and Asthma Patients Based on Constant-Pressure Inspiratory Muscle Performance
This observational study evaluates whether dynamic inspiratory muscle strength can be estimated in patients with chronic obstructive pulmonary disease (COPD) and asthma using simple clinical and performance-based measurements. Dynamic inspiratory muscle strength was assessed using the S-Index, which reflects the pressure generated during a fast and forceful inspiration while airflow is maintained.
The study included adult male patients diagnosed with COPD or asthma. Participants completed respiratory muscle strength assessment, pulmonary function testing, body composition assessment, and a fixed-pressure inspiratory muscle performance test using a threshold loading device set at 30 cmH₂O. The number of inspiratory repetitions performed until task failure and related respiratory variables were recorded.
The main aim of the study was to develop prediction models for estimating S-Index values from accessible measures such as peak inspiratory flow, inspiratory repetition performance, spirometry parameters, and body composition variables. The study may help determine whether dynamic inspiratory muscle strength can be estimated in clinical settings where direct S-Index measurement devices are not available.
Read the detailed description
Dynamic inspiratory muscle strength provides important information about the functional capacity of the inspiratory muscles. In patients with chronic respiratory diseases such as COPD and asthma, respiratory muscle function may be affected by airflow limitation, altered ventilatory mechanics, dyspnea, and reduced exercise tolerance. Although maximal inspiratory pressure is commonly used to assess respiratory muscle strength, it mainly reflects static pressure-generating capacity. The S-Index is a dynamic measure obtained during a rapid and forceful inspiratory maneuver and may provide additional information about inspiratory muscle performance under flow-dependent conditions.
This study was designed as an observational, cross-sectional predictive modeling study. Adult male patients with a clinical diagnosis of COPD or asthma were prospectively recruited from clinical units of Çorum Erol Olçok Training and Research Hospital, Hitit University, Türkiye. All participants provided informed consent before participation. The study was approved by the Hitit University Non-Interventional Research Ethics Committee.
Participants attended a familiarization session before the measurement day. During this session, the study procedures were explained, the measurement techniques were demonstrated, and participants were informed about behaviors to avoid before testing. On the measurement day, demographic information was recorded, and participants underwent dynamic inspiratory muscle strength assessment, body composition assessment, pulmonary function testing, and a fixed-pressure inspiratory muscle performance test.
The S-Index was measured using the POWERbreathe K5 device in single-breath test mode. Participants were instructed to exhale fully to residual volume and then perform the fastest and strongest possible inspiration through the device until the lungs were completely filled. Multiple trials were performed, and the highest S-Index value was used for analysis.
Pulmonary function testing was performed using standardized spirometry procedures. Forced vital capacity, forced expiratory volume in one second, the FEV1/FVC ratio, peak expiratory flow, peak inspiratory flow rate, and inspiratory volume were recorded. Body composition variables, including body weight, body mass index, fat-free mass, fat mass, and body fat percentage, were assessed using multi-frequency bioelectrical impedance analysis.
Inspiratory muscle performance was evaluated using a fixed-pressure inspiratory muscle loading task with the POWERbreathe Classic Light Resistance device set at 30 cmH₂O. Participants performed continuous inspiratory efforts through the device until task failure. The total number of valid inspiratory repetitions and the time to task failure were recorded. Task failure was defined as inability to maintain rhythmic breathing, marked reduction in inspiratory effort, technical errors, or voluntary termination due to inability to continue.
Safety was monitored throughout the testing procedures by healthcare professionals and researchers experienced in respiratory physiology and exercise testing. Testing was stopped if clinically relevant symptoms occurred, including severe dyspnea, dizziness, chest pain, wheezing, chest tightness, coughing attacks, or inability to maintain proper technique. No adverse clinical events requiring medical intervention were reported during the study.
The primary purpose of the analysis was to develop statistical and machine learning-based prediction models for estimating S-Index values. Predictor variables included demographic characteristics, body composition variables, spirometry parameters, peak inspiratory flow, inspiratory volume, number of inspiratory repetitions, and time to task failure. Regression-based models were developed and evaluated using standard prediction performance metrics, including mean squared error, mean absolute error, root mean squared error, and the coefficient of determination.
- Keywords
- Dynamic inspiratory muscle strength, S-Index, Inspiratory muscle performance, Respiratory muscle strength, Spirometry
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| COPD Patients | Adult male patients with a clinical diagnosis of chronic obstructive pulmonary disease who underwent dynamic inspiratory muscle strength assessment, spirometry, body composition assessment, and fixed-pressure inspiratory muscle performance testing. | |
| Asthma Patients | Adult male patients with a clinical diagnosis of asthma who underwent dynamic inspiratory muscle strength assessment, spirometry, body composition assessment, and fixed-pressure inspiratory muscle performance testing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic Inspiratory Muscle Strength Assessed by S-Index
Dynamic inspiratory muscle strength was assessed using the S-Index measured with the POWERbreathe K5 device in single-breath test mode. Participants performed maximal and rapid inspiratory efforts after full expiration to residual volume. The highest S-Index value obtained from repeated maximal inspiratory efforts was recorded in cmH₂O.
Measured: Day 1, during the single assessment visit
Secondary outcomes (8)
Number of Inspiratory Repetitions to Task Failure
Inspiratory muscle performance was evaluated using a fixed-pressure inspiratory muscle loading task with the POWERbreathe Classic Light Resistance device set at 30 cmH₂O. The total number of valid inspiratory repetitions completed until task failure was recorded as a count.
Measured: Day 1, during the single assessment visit
Time to Task Failure During Fixed-Pressure Inspiratory Loading
The duration of the fixed-pressure inspiratory muscle loading task was measured using a stopwatch. Time to task failure was recorded in seconds from the start of the test until the participant could no longer continue with proper technique or voluntarily stopped.
Measured: Day 1, during the single assessment visit
Forced Vital Capacity
Forced vital capacity was assessed using standardized spirometry procedures and recorded in liters.
Measured: Day 1, during the single assessment visit
Forced Expiratory Volume in One Second
Forced expiratory volume in one second was assessed using standardized spirometry procedures and recorded in liters.
Measured: Day 1, during the single assessment visit
FEV1/FVC Ratio
The ratio of forced expiratory volume in one second to forced vital capacity was calculated from standardized spirometry measurements and recorded as a percentage.
Measured: Day 1, during the single assessment visit.
Peak Expiratory Flow
Peak expiratory flow was obtained from standardized spirometry testing and recorded in liters per second.
Measured: Day 1, during the single assessment visit.
Inspiratory Volume
Inspiratory volume was obtained during pulmonary function testing and recorded in liters.
Measured: Day 1, during the single assessment visit.
Secondary Outcome Measure 7
Peak inspiratory flow rate was obtained from the inspiratory phase of the standardized flow-volume curve and recorded in liters per second.
Measured: Day 1, during the single assessment visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start2 Feb 2026
- Primary completion27 Mar 2026
- Study completion27 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hitit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet İsmail TOSUN, Hitit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07598292
- Sponsor's protocol ID
- 2026-01
- Other IDs
- 2026-01
- Acronym
- DIMS-PRED
- Status last verified
- May 2026
- First submitted
- 7 May 2026
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because no specific data sharing plan was included in the ethics approval or informed consent process. Aggregated study findings will be reported in scientific publications.
Publications
Areias GS, Santiago LR, Teixeira DS, Reis MS. Concurrent Validity of the Static and Dynamic Measures of Inspiratory Muscle Strength: Comparison between Maximal Inspiratory Pressure and S-Index. Braz J Cardiovasc Surg. 2020 Aug 1;35(4):459-464. doi: 10.21470/1678-9741-2019-0269.
PubMed 32864924Caruso P, Albuquerque AL, Santana PV, Cardenas LZ, Ferreira JG, Prina E, Trevizan PF, Pereira MC, Iamonti V, Pletsch R, Macchione MC, Carvalho CR. Diagnostic methods to assess inspiratory and expiratory muscle strength. J Bras Pneumol. 2015 Mar-Apr;41(2):110-23. doi: 10.1590/S1806-37132015000004474.
PubMed 25972965American Thoracic Society/European Respiratory Society. ATS/ERS Statement on respiratory muscle testing. Am J Respir Crit Care Med. 2002 Aug 15;166(4):518-624. doi: 10.1164/rccm.166.4.518. No abstract available.
PubMed 12186831
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction Models for Dynamic Respiratory Muscle Strength in COPD and Asthma Patients Based on Constant-Pressure Inspiratory Muscle Performance
- ClinicalTrials.gov ID
- NCT07598292
- Acronym / sponsor ID
- DIMS-PRED / 2026-01
- Keywords
- Dynamic inspiratory muscle strength, S-Index, Inspiratory muscle performance, Respiratory muscle strength, Spirometry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Hitit UniversityUniversity, hospital or other
- Study start
- 2 Feb 2026 (actual)
- Primary completion
- 27 Mar 2026 (actual)
- Study completion
- 27 Mar 2026 (actual)
- First posted
- 20 May 2026 (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.
This observational study evaluates whether dynamic inspiratory muscle strength can be estimated in patients with chronic obstructive pulmonary disease (COPD) and asthma using simple clinical and performance-based measurements. Dynamic inspiratory muscle strength was assessed using the S-Index, which reflects the pressure generated during a fast and forceful inspiration while airflow is maintained.
The study included adult male patients diagnosed with COPD or asthma. Participants completed respiratory muscle strength assessment, pulmonary function testing, body composition assessment, and a fixed-pressure inspiratory muscle performance test using a threshold loading device set at 30 cmH₂O. The number of inspiratory repetitions performed until task failure and related respiratory variables were recorded.
The main aim of the study was to develop prediction models for estimating S-Index values from accessible measures such as peak inspiratory flow, inspiratory repetition performance, spirometry parameters, and body composition variables. The study may help determine whether dynamic inspiratory muscle strength can be estimated in clinical settings where direct S-Index measurement devices are not available.
Detailed description
Dynamic inspiratory muscle strength provides important information about the functional capacity of the inspiratory muscles. In patients with chronic respiratory diseases such as COPD and asthma, respiratory muscle function may be affected by airflow limitation, altered ventilatory mechanics, dyspnea, and reduced exercise tolerance. Although maximal inspiratory pressure is commonly used to assess respiratory muscle strength, it mainly reflects static pressure-generating capacity. The S-Index is a dynamic measure obtained during a rapid and forceful inspiratory maneuver and may provide additional information about inspiratory muscle performance under flow-dependent conditions.
This study was designed as an observational, cross-sectional predictive modeling study. Adult male patients with a clinical diagnosis of COPD or asthma were prospectively recruited from clinical units of Çorum Erol Olçok Training and Research Hospital, Hitit University, Türkiye. All participants provided informed consent before participation. The study was approved by the Hitit University Non-Interventional Research Ethics Committee.
Participants attended a familiarization session before the measurement day. During this session, the study procedures were explained, the measurement techniques were demonstrated, and participants were informed about behaviors to avoid before testing. On the measurement day, demographic information was recorded, and participants underwent dynamic inspiratory muscle strength assessment, body composition assessment, pulmonary function testing, and a fixed-pressure inspiratory muscle performance test.
The S-Index was measured using the POWERbreathe K5 device in single-breath test mode. Participants were instructed to exhale fully to residual volume and then perform the fastest and strongest possible inspiration through the device until the lungs were completely filled. Multiple trials were performed, and the highest S-Index value was used for analysis.
Pulmonary function testing was performed using standardized spirometry procedures. Forced vital capacity, forced expiratory volume in one second, the FEV1/FVC ratio, peak expiratory flow, peak inspiratory flow rate, and inspiratory volume were recorded. Body composition variables, including body weight, body mass index, fat-free mass, fat mass, and body fat percentage, were assessed using multi-frequency bioelectrical impedance analysis.
Inspiratory muscle performance was evaluated using a fixed-pressure inspiratory muscle loading task with the POWERbreathe Classic Light Resistance device set at 30 cmH₂O. Participants performed continuous inspiratory efforts through the device until task failure. The total number of valid inspiratory repetitions and the time to task failure were recorded. Task failure was defined as inability to maintain rhythmic breathing, marked reduction in inspiratory effort, technical errors, or voluntary termination due to inability to continue.
Safety was monitored throughout the testing procedures by healthcare professionals and researchers experienced in respiratory physiology and exercise testing. Testing was stopped if clinically relevant symptoms occurred, including severe dyspnea, dizziness, chest pain, wheezing, chest tightness, coughing attacks, or inability to maintain proper technique. No adverse clinical events requiring medical intervention were reported during the study.
The primary purpose of the analysis was to develop statistical and machine learning-based prediction models for estimating S-Index values. Predictor variables included demographic characteristics, body composition variables, spirometry parameters, peak inspiratory flow, inspiratory volume, number of inspiratory repetitions, and time to task failure. Regression-based models were developed and evaluated using standard prediction performance metrics, including mean squared error, mean absolute error, root mean squared error, and the coefficient of determination.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPD Patients | – | –Adult male patients with a clinical diagnosis of chronic obstructive pulmonary disease who underwent dynamic inspiratory muscle strength assessment, spirometry, body composition assessment, and fixed-pressure inspiratory muscle performance testing. |
| Asthma Patients | – | –Adult male patients with a clinical diagnosis of asthma who underwent dynamic inspiratory muscle strength assessment, spirometry, body composition assessment, and fixed-pressure inspiratory muscle performance testing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consisted of adult male patients with a clinical diagnosis of chronic obstructive pulmonary disease or asthma who were recruited from clinical units of Çorum Erol Olçok Training and Research Hospital, Hitit University, Türkiye. Eligible patients were enrolled during the study period if they were able to perform the respiratory muscle and pulmonary function measurements with correct technique and provided written informed consent.
Key inclusion criteria (5 listed)
- Being 18 years of age or older
- Having a clinical diagnosis of chronic obstructive pulmonary disease or asthma
- Being able to perform fixed-pressure inspiratory muscle loading and S-Index measurements in accordance with the instructions and with correct technique
- Having experienced no additional clinical condition within the previous 12 weeks, apart from the existing chronic respiratory disease, that could acutely affect respiratory function
- Having signed the informed consent form approved by the ethics committee
Key exclusion criteria (5 listed)
- Smoking
- Inability to perform fixed-pressure inspiratory muscle loading or dynamic respiratory muscle strength assessment according to the technical requirements of the measurement protocols
- Inability to obtain reliable data due to insufficient coordination, motivation, or volitional effort
- Presence of a musculoskeletal injury or surgical history affecting the diaphragm, thorax, spine, or abdominal region that could significantly impair respiratory mechanics
- Presence of neurological conditions that may affect respiratory muscle function, such as neuromuscular diseases, peripheral nerve damage, or central nervous system disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Dynamic Inspiratory Muscle Strength Assessed by S-Index
Time frame: Day 1, during the single assessment visit
Dynamic inspiratory muscle strength was assessed using the S-Index measured with the POWERbreathe K5 device in single-breath test mode. Participants performed maximal and rapid inspiratory efforts after full expiration to residual volume. The highest S-Index value obtained from repeated maximal inspiratory efforts was recorded in cmH₂O.
8 secondary outcomes
Number of Inspiratory Repetitions to Task Failure
Time frame: Day 1, during the single assessment visit
Time to Task Failure During Fixed-Pressure Inspiratory Loading
Time frame: Day 1, during the single assessment visit
Forced Vital Capacity
Time frame: Day 1, during the single assessment visit
Forced Expiratory Volume in One Second
Time frame: Day 1, during the single assessment visit
FEV1/FVC Ratio
Time frame: Day 1, during the single assessment visit.
Peak Expiratory Flow
Time frame: Day 1, during the single assessment visit.
Inspiratory Volume
Time frame: Day 1, during the single assessment visit.
Secondary Outcome Measure 7
Time frame: Day 1, during the single assessment visit.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Background: PubMed 32864924Areias GS, Santiago LR, Teixeira DS, Reis MS. Concurrent Validity of the Static and Dynamic Measures of Inspiratory Muscle Strength: Comparison between Maximal Inspiratory Pressure and S-Index. Braz J Cardiovasc Surg. 2020 Aug 1;35(4):459-464. doi: 10.21470/1678-9741-2019-0269.
- Background: PubMed 25972965Caruso P, Albuquerque AL, Santana PV, Cardenas LZ, Ferreira JG, Prina E, Trevizan PF, Pereira MC, Iamonti V, Pletsch R, Macchione MC, Carvalho CR. Diagnostic methods to assess inspiratory and expiratory muscle strength. J Bras Pneumol. 2015 Mar-Apr;41(2):110-23. doi: 10.1590/S1806-37132015000004474.
- Background: PubMed 12186831American Thoracic Society/European Respiratory Society. ATS/ERS Statement on respiratory muscle testing. Am J Respir Crit Care Med. 2002 Aug 15;166(4):518-624. doi: 10.1164/rccm.166.4.518. No abstract available.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because no specific data sharing plan was included in the ethics approval or informed consent process. Aggregated study findings will be reported in scientific publications.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease (COPD) and Asthma, run by Hitit University 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 5 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: finished, as of the sponsor's last update on 20 May 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamic Inspiratory Muscle Strength Assessed by S-Index (time frame: Day 1, during the single assessment visit). 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 NCT07598292, which also lists 3 linked publications.
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 20 May 2026.