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

Heart Rate Variability Clinical Trial

— Hypoxia  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03439202
• Other study ID #: 2018-00006
• Status: Completed
• Phase: N/A
• Start date: March 19, 2018
• Est. completion date: February 14, 2019

Study information

• Verified date: February 2019
• Source: Fliegerärztliches Institut
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 14, 2019
• Est. primary completion date: February 14, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Hypoxia
Subject will conduct low-intensity exercise on a bike in different hypoxic conditions.

Locations

Country	Name	City	State
Switzerland	Aeromedical Center / Fliegerärztliches Institut	Dübendorf	ZH

Sponsors (2)

Lead Sponsor	Collaborator
Fliegerärztliches Institut	University of Lausanne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Concentration performance	Subjects will conduct a concentration test in each condition.	4 minutes per test
Secondary	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
Secondary	Heart rate variability (HRV)	To investigate about stress (sympathetic and parasympathetic activation) in each condition tested.	6 minutes per record
Secondary	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.