NCT00311571

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

Completed Phase 1 Last updated 1 September 2006

What this trial tests

Phase 1 trial testing Ethidronate in Simulation of Weightlessness by Anti-Orthostatic Long Term Bed Rest in 28 participants. Completed in 1 June 2003.

Timeline

1 August 2001

1 June 2003

Quick facts

Lead sponsor	Centre National d'Etudes Spatiales
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	28
Start date	1 August 2001
Estimated completion	1 June 2003
Sites	1 location across France

Drugs / interventions tested

• Ethidronate — full drug profile →
• Physical training

Conditions studied

• Simulation of Weightlessness by Anti-Orthostatic Long Term Bed Rest — all drugs for Simulation of Weightlessness by Anti-Orthostatic Long Term Bed Rest →

Sponsor

Centre National d'Etudes Spatiales — full company profile →

Who can join

Adults 25 to 45, male only, with Simulation of Weightlessness by Anti-Orthostatic Long Term Bed Rest. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Muscle size and function
• Muscle protein composition, muscle fiber type composition andmuscle enzyme content of soleus and vastus lateralis muscles
• Bone mineral content and structure
• Isokinetic muscle strength (using Cybex)
• Fluid volume shift
• Calcium metabolism and hormonal control

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effect of physical inactivity on the oxidation of saturated and monounsaturated dietary Fatty acids: results of a randomized trial.
   Bergouignan A, Schoeller DA, Normand S, Gauquelin-Koch G, et al · · 2006 · cited 66× · PMID 17016547 · DOI 10.1371/journal.pctr.0010027
2. High-intensity flywheel exercise and recovery of atrophy after 90 days bed--rest.
   Belavý DL, Ohshima H, Rittweger J, Felsenberg D. · · 2017 · cited 17× · PMID 28761699 · DOI 10.1136/bmjsem-2016-000196
3. Long non-coding RNAs Kcnq1ot1 and Lncpint are involved in skeletal muscle atrophy induced by the space exposome.
   Pérez-Díaz S, Baselet B, Lovric A, Lundberg TR, et al · · 2025 · cited 2× · PMID 40581981 · DOI 10.1113/jp288987