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

NCT03439202 | Completed

• 1 other identifier: 2018-00006
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  6 minutes per record.

Secondary Outcomes (4)

• Concentration performance

  4 minutes per test

• EEG microstates

  6 minutes per record

• Heart rate variability (HRV)

  6 minutes per record

• Cerebral blood flow

  6 minutes per record.

Study Arms (1)

No arm used

OTHER

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

Other: Hypoxia

Interventions

Hypoxia OTHER

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

Also known as: Low-intensity cycling exercise

No arm used

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Study Indication
• Male and Female subjects from 18 years to 40 years of age
• Healthy volunteer
• Signed Informed Consent after being informed

You may not qualify if:

• 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

Sponsors & Collaborators

• Fliegerärztliches Institut: lead
• University of Lausanne: collaborator

Study Sites (1)

Aeromedical Center / Fliegerärztliches Institut

Dübendorf, Canton of Zurich, 8600, Switzerland

Location

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Denis Bron, Dr. med.

  Aeromedical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No drug and no arm are used for this study. This is a clinical study, because subjects are exposed to hypoxic conditions.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Crossover randomized study

Study Record Dates

• First Submitted: January 26, 2018
• First Posted: February 20, 2018
• Study Start: March 19, 2018
• Primary Completion: February 14, 2019
• Study Completion: February 14, 2019
• Last Updated: February 15, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)