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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03439202
Recruitment Status : Completed
First Posted : February 20, 2018
Last Update Posted : February 15, 2019
University of Lausanne
Information provided by (Responsible Party):
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.

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Crossover 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 : March 19, 2018
Actual Primary Completion Date : February 14, 2019
Actual Study Completion Date : February 14, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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 Name: Low-intensity cycling exercise

Primary Outcome Measures :
  1. Baro-reflex sensitivity [ Time Frame: 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 :
  1. Concentration performance [ Time Frame: 4 minutes per test ]
    Subjects will conduct a concentration test in each condition.

  2. EEG microstates [ Time Frame: 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.

  3. Heart rate variability (HRV) [ Time Frame: 6 minutes per record ]
    To investigate about stress (sympathetic and parasympathetic activation) in each condition tested.

  4. Cerebral blood flow [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03439202

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Aeromedical Center / Fliegerärztliches Institut
Dübendorf, ZH, Switzerland, 8600
Sponsors and Collaborators
Fliegerärztliches Institut
University of Lausanne
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Principal Investigator: Denis Bron, Dr. med. Aeromedical Center
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Responsible Party: Fliegerärztliches Institut Identifier: NCT03439202    
Other Study ID Numbers: 2018-00006
First Posted: February 20, 2018    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fliegerärztliches Institut:
Baro-reflex sensitivity
Low-intensity exercise
Hear rate variability
Concentration performance
Additional relevant MeSH terms:
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Immune System Diseases