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

Primary Purpose

Baro-reflex Sensitivity, Heart Rate Variability, EEG, Microstates

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Hypoxia
Sponsored by
Fliegerärztliches Institut
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Baro-reflex Sensitivity focused on measuring Hypoxia, Baro-reflex sensitivity, Low-intensity exercise, Hear rate variability, EEG, Concentration performance

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Aeromedical Center / Fliegerärztliches Institut

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

No arm used

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Concentration performance
Subjects will conduct a concentration test in each condition.
EEG microstates
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)
To investigate about stress (sympathetic and parasympathetic activation) in each condition tested.
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.

Full Information

First Posted
January 26, 2018
Last Updated
February 14, 2019
Sponsor
Fliegerärztliches Institut
Collaborators
University of Lausanne
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1. Study Identification

Unique Protocol Identification Number
NCT03439202
Brief Title
Low Intensity Exercise in Different Normobaric/Hypobaric Normoxic/Hypoxic Conditions.
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
March 19, 2018 (Actual)
Primary Completion Date
February 14, 2019 (Actual)
Study Completion Date
February 14, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fliegerärztliches Institut
Collaborators
University of Lausanne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Baro-reflex Sensitivity, Heart Rate Variability, EEG, Microstates, Cerebral Blood Flow Regulation, Cerebral Oxygenation, Oxygen Saturation, Concentration Performance
Keywords
Hypoxia, Baro-reflex sensitivity, Low-intensity exercise, Hear rate variability, EEG, Concentration performance

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No arm used
Arm Type
Other
Arm Description
No drug use for this study. No arm used in this study. Subjects are exposed to hypoxic conditions (clinical study).
Intervention Type
Other
Intervention Name(s)
Hypoxia
Other Intervention Name(s)
Low-intensity cycling exercise
Intervention Description
Subject will conduct low-intensity exercise on a bike in different hypoxic conditions.
Primary Outcome Measure Information:
Title
Baro-reflex sensitivity
Description
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.
Time Frame
6 minutes per record.
Secondary Outcome Measure Information:
Title
Concentration performance
Description
Subjects will conduct a concentration test in each condition.
Time Frame
4 minutes per test
Title
EEG microstates
Description
Microstates analysis to investigate how electrical cerebral activity is affected at rest in hypoxia and influenced by low intensity cycling exercise.
Time Frame
6 minutes per record
Title
Heart rate variability (HRV)
Description
To investigate about stress (sympathetic and parasympathetic activation) in each condition tested.
Time Frame
6 minutes per record
Title
Cerebral blood flow
Description
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.
Time Frame
6 minutes per record.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denis Bron, Dr. med.
Organizational Affiliation
Aeromedical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aeromedical Center / Fliegerärztliches Institut
City
Dübendorf
State/Province
ZH
ZIP/Postal Code
8600
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

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

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