- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
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.
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: OTHER
- Perspectives temporelles: PROSPECTIVE
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Forced Expiratory Volume in One Second (FEV1 % predicted)
Délai: 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)
Délai: Measured at baseline/assessment.
|
Maximal inspiratory pressure will be assessed to determine respiratory muscle strength. |
Measured at baseline/assessment.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Maximal expiratory pressure (PEmax)
Délai: Measured at baseline/assessment.
|
Maximal expiratory pressure will be assessed to determine respiratory muscle strength. |
Measured at baseline/assessment.
|
|
Respiratory Muscle Endurance Score
Délai: 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)
Délai: 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)
Délai: 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)
Délai: Measured at baseline/assessment.
|
The six-minute walk test will be performed to measure functional capacity distance in meters. |
Measured at baseline/assessment.
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Troubles cérébrovasculaires
- Maladies du cerveau
- Maladies du système nerveux central
- Maladies du système nerveux
- Maladies vasculaires
- Maladies cardiovasculaires
- Accident vasculaire cérébral
- Phénomènes physiologiques circulatoires et respiratoires
- Mécanique respiratoire
- Respiration
- Phénomènes physiologiques respiratoires
- Inhalation
Autres numéros d'identification d'étude
- 116
Informations sur les médicaments et les dispositifs, documents d'étude
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