- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07840703
Symptomatic Hyperventilation in Individuals Living With Stroke
Impact of Symptomatic Hyperventilation on Respiratory Parameters and Functional Capacity Among Individuals Living With Stroke: A Comparative Study
This study will investigate the effects of hyperventilation syndrome on respiratory muscle strength, respiratory muscle endurance, pulmonary functions, and functional capacity in individuals living with stroke, and in this context, stroke patients with and without hyperventilation syndrome based on Nijmegen Questionnaire scores will be compared to evaluate the relationship between symptom burden and respiratory parameters.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
The study population will comprise adult individuals diagnosed with stroke (ischaemic or haemorrhagic) who are in the post-stroke period. Participants will be recruited and screened based on the Nijmegen Questionnaire score to form two distinct cohorts: individuals presenting with symptomatic hyperventilation syndrome and individuals without hyperventilation syndrome.
Descrizione
Inclusion Criteria:
- Individuals who will be diagnosed with a confirmed first-ever or recurrent stroke (ischaemic or haemorrhagic) verified by neuroimaging (CT or MRI).
- Individuals who will be in the chronic or subacute post-stroke period (medically stable following stroke onset).
- Individuals aged 18 years and older.
- Individuals who will be classified into either the hyperventilation syndrome group based on a Nijmegen Questionnaire score of ≥23 or the control group based on a score of <23.
- Individuals who will be able to comprehend instructions and cooperate adequately with pulmonary function tests, respiratory muscle testing, and physical performance assessments.
- Individuals who will provide written informed consent to participate in the study.
Exclusion Criteria:
- Individuals who will present with severe cognitive impairment, aphasia, or psychiatric disorders that will prevent reliable completion of questionnaires (such as the Nijmegen Questionnaire) or cooperation with test procedures.
- Individuals who will have pre-existing primary chronic obstructive pulmonary disease (COPD), asthma, restrictive thoracic diseases, or other major pre-existing pulmonary pathologies that will confound pulmonary function test results.
- Individuals who will have unstable cardiovascular conditions (e.g., recent myocardial infarction within the past 3-6 months, unstable angina pectoris, uncontrolled malignant arrhythmias, or uncontrolled severe hypertension) that will pose a risk during physical testing (such as the six-minute walk test).
- Individuals who will have severe orthopedic, musculoskeletal, or lower extremity peripheral disorders unrelated to stroke that will independently limit functional capacity and walking distance (6MWD).
- Individuals who will have active respiratory tract infections or acute pulmonary illnesses at the time of evaluation. Individuals who will be participating in an active pulmonary rehabilitation program or receiving respiratory muscle training concurrently.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: OTHER
- Prospettive temporali: PROSPECTIVE
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
|
Hyperventilation Syndrome Group
|
Both groups will undergo comprehensive evaluations including pulmonary function tests (FEV1, FVC, PEF), respiratory muscle strength (PImax, PEmax), respiratory muscle endurance tests, the Nijmegen Questionnaire, and the six-minute walk test (6MWT) to assess functional capacity. |
|
Without Hyperventilation Syndrome Group
|
Both groups will undergo comprehensive evaluations including pulmonary function tests (FEV1, FVC, PEF), respiratory muscle strength (PImax, PEmax), respiratory muscle endurance tests, the Nijmegen Questionnaire, and the six-minute walk test (6MWT) to assess functional capacity. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Forced Expiratory Volume in One Second (FEV1 % predicted)
Lasso di tempo: Measured at baseline/assessment
|
FEV1 percent predicted values will be measured to evaluate and compare pulmonary function between the hyperventilation syndrome group and the control group. |
Measured at baseline/assessment
|
|
Maximal inspiratory pressure (PImax)
Lasso di tempo: Measured at baseline/assessment.
|
Maximal inspiratory pressure will be assessed to determine respiratory muscle strength. |
Measured at baseline/assessment.
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Maximal expiratory pressure (PEmax)
Lasso di tempo: Measured at baseline/assessment.
|
Maximal expiratory pressure will be assessed to determine respiratory muscle strength. |
Measured at baseline/assessment.
|
|
Respiratory Muscle Endurance Score
Lasso di tempo: Measured at baseline/assessment.
|
Respiratory muscle endurance scores will be recorded to evaluate breathing endurance between groups. |
Measured at baseline/assessment.
|
|
Forced Vital Capacity (FVC)
Lasso di tempo: Measured at baseline/assessment.
|
FVC percentage value will be analyzed to assess restrictive patterns and flow rates. |
Measured at baseline/assessment.
|
|
Peak Expiratory Flow (PEF)
Lasso di tempo: Measured at baseline/assessment.
|
PEF value will be analyzed to assess restrictive patterns and flow rates. |
Measured at baseline/assessment.
|
|
Six-Minute Walk Distance (6MWD)
Lasso di tempo: Measured at baseline/assessment.
|
The six-minute walk test will be performed to measure functional capacity distance in meters. |
Measured at baseline/assessment.
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 116
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .