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Sponsors and Collaborators: |
Centre National d'Etudes Spatiales European Space Agency National Space Development Agency of Japan |
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Information provided by: | Centre National d'Etudes Spatiales |
ClinicalTrials.gov Identifier: | NCT00311571 |
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 provide study conditions that are more accessible than during space flight. The European Space Agency, ESA together with the French national space agency, CNES and the Japanese national space agency, NASDA are performing extensive studies using long duration bed rest.
Previous studies including several long and short term bed rest campaigns have yielded significant medical data on the physiological changes induced by space flight. These data can be used to study the effect of countermeasures, methods helping to prevent these physiological changes.
The long duration bed rest, lasting 3 months undertakes a variety of investigations involving 28 subjects. This study focuses on countermeasures, studying the effect of a bone tissue stabilisation medication and resistive exercises to determine their suitability for use during long duration stays on ISS.
The physiological changes recorded during space flight and bed rest mimic those observed in some diseases and in the aging process. Significant clinical applications are expected as a direct result of this experiment and future equivalent studies.
Condition | Intervention | Phase |
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Simulation of Weightlessness by Anti-Orthostatic Long Term Bed Rest |
Drug: Ethidronate Behavioral: Physical training |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Simulation of a Mission Aboard the International Space Station by a Long Duration Anti-Orthostatic Bed Confinement at – 6° (90 Days) on Healthy Subjects:1/Perfecting of Preventive Methods (Muscular Exercise and Biphosphonates) and Evaluation of the Effects on the Locomotion and Cardiovascular Systems and on the Lipid and Energy Metabolisms. 2/Pharmacokinetic Assessment: Effects of Position on the Absorption Mechanisms: Pharmacokinetics of Paracetamol Used as Model to Study Oral Absorption in Simulated Weightlessness |
Estimated Enrollment: | 28 |
Study Start Date: | August 2001 |
Estimated Study Completion Date: | June 2003 |
Ages Eligible for Study: | 25 Years to 45 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
France | |
MEDES-IMPS | |
Toulouse, France, 31405 |
Principal Investigator: | Jacques Bernard, Dr | MEDES-IMPS |
Study ID Numbers: | MEDES/00-433 |
Study First Received: | April 4, 2006 |
Last Updated: | September 1, 2006 |
ClinicalTrials.gov Identifier: | NCT00311571 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
bedrest spaceflight Weightlessness Countermeasure |
Diphosphonates Healthy Acetaminophen |