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Retrospective Analysis of CPET and Cognitive Tests of Healthy Individuals, Treated With 60 Treatment of HBOT (HBOT)

2026年5月17日 更新者:Assaf-Harofeh Medical Center

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.

This retrospective observational study evaluates physiological and cognitive changes following a series of 60 hyperbaric oxygen therapy (HBOT) sessions in healthy individuals. Participants underwent treatment five days per week, each session included 90 minutes exposure to 100% oxygen at 2ATA with a five-minute air break every 20 minutes. Pre- and post-treatment data include cardiopulmonary exercise testing (CPET) and standardized cognitive assessments. The study aims to characterize associations between changes in cardiorespiratory fitness and cognitive performance following repeated HBOT exposure in a real-world clinical cohort

研究概览

详细说明

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

研究类型

观察性的

注册 (估计的)

1000

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

取样方法

非概率样本

研究人群

This retrospective cohort includes adults treated at the Sagol Center who completed a full course of 60 hyperbaric oxygen therapy sessions. All participants underwent pre- and post-treatment cardiopulmonary exercise testing and standardized cognitive evaluations as part of routine clinical care. Data were extracted from institutional clinical databases for retrospective analysis.

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
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

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Exercise Duration During CPET
大体时间: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
大体时间: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
大体时间: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)
大体时间: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
大体时间: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
大体时间: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
大体时间: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)

次要结果测量

结果测量
措施说明
大体时间
Change in Cognitive Function Following Hyperbaric Oxygen Therapy
大体时间: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)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年12月1日

初级完成 (估计的)

2027年12月1日

研究完成 (估计的)

2028年3月30日

研究注册日期

首次提交

2026年4月16日

首先提交符合 QC 标准的

2026年5月17日

首次发布 (实际的)

2026年5月19日

研究记录更新

最后更新发布 (实际的)

2026年5月19日

上次提交的符合 QC 标准的更新

2026年5月17日

最后验证

2026年2月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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