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.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,000
- 主要终点
- Exercise Duration During CPET
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Hyperbaric Oxygen Therapy - HBOT (Other)
结局指标
主要结局
Exercise Duration During CPET
时间窗: 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
Peak Workload During CPET
时间窗: Baseline and post-treatment (approximately 4-6 months)
Highest external work rate achieved during CPET on a cycle ergometer. Unit of Measure: Watts (W)
Peak Metabolic Equivalent (METs) During CPET
时间窗: Baseline and post-treatment (approximately 4-6 months)
Highest metabolic equivalent level achieved during treadmill-based CPET. Unit of Measure: METs
Ventilatory Threshold Oxygen Uptake (VT1/VT2)
时间窗: 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
Ventilatory Threshold Workload
时间窗: Baseline and post-treatment (approximately 4-6 months)
Workload achieved at ventilatory thresholds (VT1 and VT2) during CPET. Unit of Measure: Watts (W)
Ventilatory Threshold Heart Rate
时间窗: 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)
Time to Ventilatory Threshold
时间窗: 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
次要结局
- Change in Cognitive Function Following Hyperbaric Oxygen Therapy(Baseline and post-treatment (approximately 4-6 months))