Status:

COMPLETED

Toulouse Male Long Term Bed Rest 2001-2002

Lead Sponsor:

Centre National d'Etudes Spatiales

Collaborating Sponsors:

European Space Agency

National Space Development Agency, Japan

Conditions:

Simulation of Weightlessness by Anti-Orthostatic Long Term Bed Rest

Eligibility:

MALE

25-45 years

Phase:

PHASE1

Brief Summary

Microgravity during space flight induces physiological changes that affect astronauts' health and performance. Space flight simulations such as prolonged bed rest can mimic some of these changes and p...

Detailed Description

The spaceflights undertaken to date demonstrated that Man can adapt to the conditions existing in space, particularly to weightlessness. However, the space environment and the prevailing micro-gravity...

Eligibility Criteria

Inclusion

  • Healthy male volunteer , citizen of the European Community.
  • Age 25 to 45,
  • Non smokers,
  • No alcohol, no drug dependence and no medical treatment,
  • Height 165 cm to 185 cm,
  • No overweight nor excessive thinness. BMI (weight Kg/ height m2) between 20 and 27,
  • No personal nor family past record of chronic or acute disease which could affect the physiological data and/or create a risk for the subject during the experiment,
  • Subject to be covered by a Social Security system,
  • Free of any engagement during four consecutive months.

Exclusion

  • Having given blood (more than 300ml) in a period of three months or less before the start of the experiment,
  • Subject already participating in a clinical research experimentation,
  • Poor tolerance to blood sampling,
  • Past record of orthostatic intolerance,
  • Cardiac rhythm disorders,
  • Allergies,
  • Intensive sport training,
  • Fractures or tendon laceration since less than one year,
  • Chronic back pains,
  • Past records of thrombophlebitis,
  • Presence of metallic implants,
  • Special food diet,
  • Sleep disorders :Lark and owl type,Subject sleeping more than 10 hours or less than 5 hours,
  • Photosensitive epilepsy.

Key Trial Info

Start Date :

August 1 2001

Trial Type :

INTERVENTIONAL

End Date :

June 1 2003

Estimated Enrollment :

28 Patients enrolled

Trial Details

Trial ID

NCT00311571

Start Date

August 1 2001

End Date

June 1 2003

Last Update

September 4 2006

Active Locations (1)

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1

Medes-Imps

Toulouse, France, 31405