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| ID | Type | Description | Link |
|---|---|---|---|
| 2026-01 | Other Identifier | Hitit University Non-Interventional Research Ethics Committee |
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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 cmHâ‚‚O. 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.
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 cmHâ‚‚O. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 cmHâ‚‚O. | Day 1, during the single assessment visit |
| Measure | Description | Time Frame |
|---|---|---|
| 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 cmHâ‚‚O. The total number of valid inspiratory repetitions completed until task failure was recorded as a count. | Day 1, during the single assessment visit |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hitit University Çorum Erol Olçok Training and Research Hospital | Çorum | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32864924 | Background | 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. | |
| 25972965 | Background | Caruso 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. |
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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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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D001249 | Asthma |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| 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. | Day 1, during the single assessment visit |
| Forced Vital Capacity | Forced vital capacity was assessed using standardized spirometry procedures and recorded in liters. | 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. | 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. | 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. | Day 1, during the single assessment visit. |
| Inspiratory Volume | Inspiratory volume was obtained during pulmonary function testing and recorded in liters. | 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. | Day 1, during the single assessment visit. |
| 12186831 | Background | American 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. |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001982 | Bronchial Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |