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

Sponsor

Fliegerärztliches Institut (Other)

Overall Status

Completed

CT.gov ID

NCT03439202

Collaborator

University of Lausanne (Other)

Enrollment

Location

Arm

10.9

Actual Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Baro-reflex Sensitivity Heart Rate Variability EEG, Microstates Cerebral Blood Flow Regulation Cerebral Oxygenation Oxygen Saturation Concentration Performance	Other: Hypoxia	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Crossover randomized studyCrossover randomized study

Masking:

None (Open Label)

Masking Description:

No drug and no arm are used for this study. This is a clinical study, because subjects are exposed to hypoxic conditions.

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Mar 19, 2018

Actual Primary Completion Date :

Feb 14, 2019

Actual Study Completion Date :

Feb 14, 2019

Arms and Interventions

Arm	Intervention/Treatment
Other: No arm used No drug use for this study. No arm used in this study. Subjects are exposed to hypoxic conditions (clinical study).	Other: Hypoxia Subject will conduct low-intensity exercise on a bike in different hypoxic conditions. Other Names: Low-intensity cycling exercise

Arm

Intervention/Treatment

Other: No arm used

No drug use for this study. No arm used in this study. Subjects are exposed to hypoxic conditions (clinical study).

Other: Hypoxia

Subject will conduct low-intensity exercise on a bike in different hypoxic conditions.

Other Names:

Low-intensity cycling exercise

Outcome Measures

Primary Outcome Measures

Baro-reflex sensitivity [6 minutes per record.]
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.

Secondary Outcome Measures

Concentration performance [4 minutes per test]
Subjects will conduct a concentration test in each condition.
EEG microstates [6 minutes per record]
Microstates analysis to investigate how electrical cerebral activity is affected at rest in hypoxia and influenced by low intensity cycling exercise.
Heart rate variability (HRV) [6 minutes per record]
To investigate about stress (sympathetic and parasympathetic activation) in each condition tested.
Cerebral blood flow [6 minutes per record.]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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