Retrospective Analysis of CPET and Cognitive Tests of Healthy Individuals, Treated With 60 Treatment of HBOT (HBOT)
Retrospective Analysis of Cardiopulmonary Exercise Tests and Cognitive Tests of Healthy Individuals Age 18+ Years, Treated at the Sagol Center for Hyperbaric Medicine and Research With 60 Hyperbaric Oxygen Therapy Treatments.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
This retrospective observational study analyzes data collected from healthy adults who completed a full treatment series of 60 hyperbaric oxygen therapy (HBOT) sessions at the Sagol Center for Hyperbaric Medicine and Research. Each session included 90 minutes exposure to 100% oxygen at 2ATA with a five-minute air break every 20 minutes
The primary objective is to evaluate physiological adaptations to repeated HBOT exposure using cardiopulmonary exercise testing (CPET) metrics, including aerobic capacity and exercise performance parameters. A secondary objective is to examine concurrent changes in cognitive function as assessed by standardized neurocognitive testing performed as part of routine clinical evaluation.
The study utilizes de-identified data extracted from clinical records and institutional databases. As a retrospective analysis, no intervention or allocation was performed for research purposes. The study aims to explore potential relationships between changes in physical performance and cognitive outcomes following HBOT in in a real-world clinical cohort
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Eldad Mr Yaakobo, Ms
- Numéro de téléphone: +972542092860
- E-mail: yaakobi.eldad@gmail.com
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Adults aged 18-65 years
- Completed a full treatment series of 60 hyperbaric oxygen therapy (HBOT) sessions at the Sagol Center
- Availability of pre- and post-treatment cardiopulmonary exercise testing (CPET) data
- Availability of pre- and post-treatment cognitive assessment data
Exclusion Criteria:
- Inability to complete a maximal CPET test, pre and post HBOT or Missing pre- or post-treatment CPET data.
- Incomplete HBOT treatment series
- Missing cognitive assessment data
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Adults Treated With HBOT
Retrospective cohort of adults who completed a full treatment series of 60 hyperbaric oxygen therapy (HBOT) sessions at 2 atmospheres absolute (ATA) breathing 100% oxygen, and were approved for a maximal cardiopulmonary exercise testing (CPET).
Prticipants underwent pre- and post-treatment cardiopulmonary exercise testing (CPET) and cognitive assessments as part of routine clinical evaluation.
|
60 consecutive hyperbaric oxygen treatment (HBOT) sessions, 5 sessions per week within a three months' period
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Exercise Duration During CPET
Délai: Baseline and post-treatment (approximately 4-6 months)
|
Total duration the participant is able to continue the cardiopulmonary exercise testing (CPET) protocol until voluntary exhaustion or termination criteria are reached. Unit of Measure: Minutes |
Baseline and post-treatment (approximately 4-6 months)
|
|
Peak Workload During CPET
Délai: Baseline and post-treatment (approximately 4-6 months)
|
Highest external work rate achieved during CPET on a cycle ergometer. Unit of Measure: Watts (W) |
Baseline and post-treatment (approximately 4-6 months)
|
|
Peak Metabolic Equivalent (METs) During CPET
Délai: Baseline and post-treatment (approximately 4-6 months)
|
Highest metabolic equivalent level achieved during treadmill-based CPET. Unit of Measure: METs |
Baseline and post-treatment (approximately 4-6 months)
|
|
Ventilatory Threshold Oxygen Uptake (VT1/VT2)
Délai: Baseline and post-treatment (approximately 4-6 months)
|
Oxygen uptake measured at ventilatory thresholds (VT1 and VT2) during CPET, reflecting metabolic transition during exercise.
Unit of Measure: mL/kg/min
|
Baseline and post-treatment (approximately 4-6 months)
|
|
Ventilatory Threshold Workload
Délai: Baseline and post-treatment (approximately 4-6 months)
|
Workload achieved at ventilatory thresholds (VT1 and VT2) during CPET. Unit of Measure: Watts (W) |
Baseline and post-treatment (approximately 4-6 months)
|
|
Ventilatory Threshold Heart Rate
Délai: Baseline and post-treatment (approximately 4-6 months)
|
Heart rate recorded at ventilatory thresholds (VT1 and VT2) during CPET.
Unit of Measure: Beats per minute (bpm)
|
Baseline and post-treatment (approximately 4-6 months)
|
|
Time to Ventilatory Threshold
Délai: Baseline and post-treatment (approximately 4-6 months)
|
Elapsed exercise time at which ventilatory thresholds (VT1 and VT2) are reached during CPET.
Unit of Measure: Minutes
|
Baseline and post-treatment (approximately 4-6 months)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Cognitive Function Following Hyperbaric Oxygen Therapy
Délai: Baseline and post-treatment (approximately 4-6 months)
|
Change in standardized cognitive performance scores measured before and after completion of 60 hyperbaric oxygen therapy sessions using NeuroTrax cognitive battery test.
|
Baseline and post-treatment (approximately 4-6 months)
|
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
Autres numéros d'identification d'étude
- 0262-24 ASF
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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