Low Intensity Exercise in Different Normobaric/Hypobaric... | NCT03439202

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 19, 2018Actual

Primary Completion Date

Feb 14, 2019Actual

Completion Date

Feb 14, 2019Actual

First Submitted Date

Jan 26, 2018

First Submission Date that Met QC Criteria

Feb 13, 2018

First Posted Date

Feb 20, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 14, 2019

Last Update Posted Date

Feb 15, 2019Actual

Name	Class
University of Lausanne	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Hypoxia	Other	Subject will conduct low-intensity exercise on a bike in different hypoxic conditions.	No arm used

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Concentration performance	Subjects will conduct a concentration test in each condition.	4 minutes per test
EEG microstates	Microstates analysis to investigate how electrical cerebral activity is affected at rest in hypoxia and influenced by low intensity cycling exercise.

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Denis Bron, Dr. med.	Aeromedical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Aeromedical Center / Fliegerärztliches Institut		Dübendorf	Canton of Zurich	8600	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

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.

Who Masked

Not provided

ID	Term
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms