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.|
|ClinicalTrials.gov Identifier: NCT03439202|
Recruitment Status : Active, not recruiting
First Posted : February 20, 2018
Last Update Posted : March 20, 2018
|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|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.|
|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|
|Estimated Primary Completion Date :||July 30, 2018|
|Estimated Study Completion Date :||October 30, 2018|
No arm used
No drug use for this study. No arm used in this study. Subjects are exposed to hypoxic conditions (clinical study).
Subject will conduct low-intensity exercise on a bike in different hypoxic conditions.
Other Name: Low-intensity cycling exercise
- 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.
- Concentration performance [ Time Frame: 4 minutes per test ]Subjects will conduct a concentration test in each condition.
- 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.
- Heart rate variability (HRV) [ Time Frame: 6 minutes per record ]To investigate about stress (sympathetic and parasympathetic activation) in each condition tested.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT03439202
|Aeromedical Center / Fliegerärztliches Institut|
|Dübendorf, ZH, Switzerland, 8600|
|Principal Investigator:||Denis Bron, Dr. med.||Aeromedical Center|