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- Ensaio Clínico NCT07596641
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.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Eldad Mr Yaakobo, Ms
- Número de telefone: +972542092860
- E-mail: yaakobi.eldad@gmail.com
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
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.
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60 consecutive hyperbaric oxygen treatment (HBOT) sessions, 5 sessions per week within a three months' period
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Exercise Duration During CPET
Prazo: 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)
|
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Peak Workload During CPET
Prazo: 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
Prazo: 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)
Prazo: 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)
|
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Ventilatory Threshold Workload
Prazo: 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
Prazo: Baseline and post-treatment (approximately 4-6 months)
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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)
|
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Time to Ventilatory Threshold
Prazo: Baseline and post-treatment (approximately 4-6 months)
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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)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Cognitive Function Following Hyperbaric Oxygen Therapy
Prazo: 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)
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 0262-24 ASF
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