Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Predicting Dynamic Inspiratory Muscle Strength in COPD and Asthma Patients (DIMS-PRED)

17. maj 2026 opdateret af: Mehmet İsmail TOSUN, Hitit University

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.

Studieoversigt

Status

Afsluttet

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

123

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Çorum, Tyrkiet (Türkiye)
        • Hitit University Çorum Erol Olçok Training and Research Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Dynamic Inspiratory Muscle Strength Assessed by S-Index
Tidsramme: 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.
Day 1, during the single assessment visit

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Inspiratory Repetitions to Task Failure
Tidsramme: Day 1, during the single assessment visit
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.
Day 1, during the single assessment visit
Time to Task Failure During Fixed-Pressure Inspiratory Loading
Tidsramme: Day 1, during the single assessment visit
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
Tidsramme: Day 1, during the single assessment visit
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
Tidsramme: Day 1, during the single assessment visit
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
Tidsramme: Day 1, during the single assessment visit.
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
Tidsramme: Day 1, during the single assessment visit.
Peak expiratory flow was obtained from standardized spirometry testing and recorded in liters per second.
Day 1, during the single assessment visit.
Inspiratory Volume
Tidsramme: Day 1, during the single assessment visit.
Inspiratory volume was obtained during pulmonary function testing and recorded in liters.
Day 1, during the single assessment visit.
Secondary Outcome Measure 7
Tidsramme: Day 1, during the single assessment visit.
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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

2. februar 2026

Primær færdiggørelse (Faktiske)

27. marts 2026

Studieafslutning (Faktiske)

27. marts 2026

Datoer for studieregistrering

Først indsendt

7. maj 2026

Først indsendt, der opfyldte QC-kriterier

17. maj 2026

Først opslået (Faktiske)

20. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner