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OpenTrials
Completed

NCT Number: NCT03439202

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

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.

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Key information

Conditions

Baro-reflex Sensitivity Cerebral Blood Flow Regulation Cerebral Oxygenation Concentration Performance EEG, Microstates Heart Rate Variability Hypoxia Oxygen Saturation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aeromedical Center / Fliegerärztliches Institut

Dübendorf, Canton of Zurich, 8600, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hypoxia

Other

Subject will conduct low-intensity exercise on a bike in different hypoxic conditions.

Other names: Low-intensity cycling exercise

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Fliegerärztliches Institut

Other

Collaborators

  • University of Lausanne

Registry information

Official study 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.

Acronym: Hypoxia

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 20, 2018
Registry last updated
Feb 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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