Toulouse Male Long Term Bed Rest 2001-2002

This study has been completed.
Sponsor:
Collaborators:
European Space Agency
National Space Development Agency of Japan
Information provided by:
Centre National d'Etudes Spatiales
ClinicalTrials.gov Identifier:
NCT00311571
First received: April 4, 2006
Last updated: September 1, 2006
Last verified: April 2006
  Purpose

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
Simulation of Weightlessness by Anti-Orthostatic Long Term Bed Rest
Drug: Ethidronate
Behavioral: Physical training
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Centre National d'Etudes Spatiales:

Primary Outcome Measures:
  • 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
  • Sleep assessment by questionnaires and actigraphy
  • RR interval from an ECG lead signal by an high impedance probe, Systolic (SAP), Diastolic (DAP) and Mean arterial pressure (MAP) by Finapres (or Portapres) andRespiration by a piezoelectric pneumobelt,
  • Acetaminophen pharmacokinetic parameters,
  • 24 h profile of spine geometry,flexibility index of spine, activity of lower back muscles,
  • and subjective rating of back pain
  • Maximal oxygen consumption.
  • Cardiovascular oxygen transport (oxygen delivery and oxygen return), requiring measurement of cardiac output, heart rate, arterialized blood gas composition, and arterial oxygen saturation.
  • Gas exchange kinetics at the onset and offset of exercise, requiring measurement of breath-by-breath ventilation and expired gas composition.
  • Blood volume
  • Plasma concentrations of arginin vasopressin, atrial natriuretic peptide, renin, endothelin, cyclic GMP and catecholamines. Urine concentrations of catecholamines, arginin vasopressin and cyclic GMP Blood concentration of nitric oxide.
  • Total energy expenditure, Lipid metabolism, body composition, water turnover and the formation of metabolic water.
  • Heart rate variability and post-ganglionic sympathetic nerve activity.
  • Arterial cardiac chronotropic baroreflex sensitivity and ventricular interdependence.
  • Ventricular mass and cardiac dimension.
  • Muscle architecture, including angle of pennation, fibre length, muscle thickness and muscle cross-sectional area
  • Energetics and biomechanics of walking and running
  • Parameters of vascular peripheral hemodynamics
  • Parameters of central hemodynamics

Estimated Enrollment: 28
Study Start Date: August 2001
Estimated Study Completion Date: June 2003
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   25 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00311571

Locations
France
Medes-Imps
Toulouse, France, 31405
Sponsors and Collaborators
Centre National d'Etudes Spatiales
European Space Agency
National Space Development Agency of Japan
Investigators
Principal Investigator: Jacques Bernard, Dr MEDES-IMPS
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00311571     History of Changes
Other Study ID Numbers: MEDES/00-433
Study First Received: April 4, 2006
Last Updated: September 1, 2006
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre National d'Etudes Spatiales:
bedrest
spaceflight
Weightlessness
Countermeasure

ClinicalTrials.gov processed this record on April 17, 2014