Low Intensity Exercise in Different Normobaric/Hypobaric Normoxic/Hypoxic Conditions.

Study Overview
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Brief Summary
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The main goal of this project is to investigate how low intensity cycling exercise (1.5W/kg, for 6 minutes) influences cerebral functions, such as: Cerebral blood flow, oxygenation, and other physiological variables in different normobaric and hypobaric hypoxic conditions.

Detailed Description
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Subjects will bike at 1W/kg for 6 minutes at different simulated altitude level in the hypobaric chamber at the FAI in Dübendorf. Concentration performance also will be measured to better understand how hypobaric and hypoxia conditions may affect physiological responses, cerebral and cognitive functions.

Official Title
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The Effects of Low Intensity Exercise in Hypobaric vs. Normobaric Normoxic and Hypoxic Conditions on Baroreflex Sensitivity, Physiological Responses and Cerebral Functions in Pilots.

Conditions
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Baro-reflex Sensitivity, Heart Rate Variability, EEG, Microstates, Cerebral Blood Flow Regulation, Cerebral Oxygenation, Oxygen Saturation, Concentration Performance

Intervention / Treatment
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* Other: Hypoxia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Study Indication Male and Female subjects from 18 years to 40 years of age Healthy volunteer Signed Informed Consent after being informed Exclusion Criteria: Contraindications to the study intervention. Define drugs, treatments or interventions not allowed during the study or for specific periods of time prior to the intervention, Women who are pregnant or breast feeding, Intention to become pregnant during the course of the study, Known or suspected non-compliance, drug or alcohol abuse, Previous problem with hypoxia or altitude exposure, Known pathologies/diseases Relevant medical disorders Anemia or poor health History of flight sickness

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Crossover randomized study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: No arm used<br>No drug use for this study. No arm used in this study. Subjects are exposed to hypoxic conditions (clinical study). | Other: Hypoxia<br>* Subject will conduct low-intensity exercise on a bike in different hypoxic conditions.<br>* Other names: Low-intensity cycling exercise;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baro-reflex sensitivity | To test the strength of relationship between RR interval and systolic blood pressure in human. Measurement before and after low intensity exercise in each condition. | 6 minutes per record. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration performance | Subjects will conduct a concentration test in each condition. | 4 minutes per test | 
| EEG microstates | Microstates analysis to investigate how electrical cerebral activity is affected at rest in hypoxia and influenced by low intensity cycling exercise. | 6 minutes per record | 
| Heart rate variability (HRV) | To investigate about stress (sympathetic and parasympathetic activation) in each condition tested. | 6 minutes per record | 
| Cerebral blood flow | Regulation of cerebral blood flow in hypoxia at rest and during low-intensity exercise. Measurement before, during and after low intensity exercise in each condition. 6 minutes recording per measurement. | 6 minutes per record. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hear rate variability, Concentration performance, Hypoxia, Baro-reflex sensitivity, Low-intensity exercise, EEG