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

Not Applicable

Completed

• Conditions: Cerebral Oxygenation; Oxygen Saturation; Baro-reflex Sensitivity; EEG, Microstates; Heart Rate Variability; Cerebral Blood Flow Regulation; Concentration Performance
• Interventions: Other: Hypoxia

• Registration Number: NCT03439202
• Lead Sponsor: Fliegerärztliches Institut

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.

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 Timeline

• Study First Submitted: 2018-01-26
• Study First Submitted QC: 2018-02-13
• Study First Posted: 2018-02-20
• Study Start: 2018-03-19
• Status Verified: 2019-02
• Primary Completion: 2019-02-14
• Study Completion: 2019-02-14
• Last Update Submitted: 2019-02-14
• Last Update Posted: 2019-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Aeromedical Center / Fliegerärztliches Institut; 🇨🇭 Dübendorf, ZH, Switzerland