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

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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • ZH
    • Dübendorf, ZH, Switzerland, 8600
      • Aeromedical Center / Fliegerärztliches Institut

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Fliegerärztliches Institut
• Collaborators: University of Lausanne
• Investigators: Principal Investigator: Denis Bron, Dr. med., Aeromedical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2018
• Primary Completion (Actual): February 14, 2019
• Study Completion (Actual): February 14, 2019

Study Registration Dates

• First Submitted: January 26, 2018
• First Submitted That Met QC Criteria: February 13, 2018
• First Posted (Actual): February 20, 2018

Study Record Updates

• Last Update Posted (Actual): February 15, 2019
• Last Update Submitted That Met QC Criteria: February 14, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Hypoxia; EEG; Concentration performance; Baro-reflex sensitivity; Low-intensity exercise; Hear rate variability
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: 2018-00006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No