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

NCT ID: NCT03439202

Last Updated: 2019-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-19
• Study Completion Date: 2019-02-14

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.

Conditions

Baro-reflex Sensitivity; Heart Rate Variability; EEG, Microstates; Cerebral Blood Flow Regulation; Cerebral Oxygenation; Oxygen Saturation; Concentration Performance

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

No arm used

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

Group Type: OTHER

Hypoxia

Intervention Type: OTHER

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

Interventions

Hypoxia

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

Intervention Type: OTHER

Other Intervention Names

Low-intensity cycling exercise

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Lausanne

OTHER

Sponsor Role: collaborator

Fliegerärztliches Institut

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Denis Bron, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Aeromedical Center

Locations

Aeromedical Center / Fliegerärztliches Institut

Dübendorf, Canton of Zurich, Switzerland

Countries

Switzerland

Other Identifiers

2018-00006

Identifier Type: -

Identifier Source: org_study_id