Toulouse Male Long Term Bed Rest 2001-2002

NCT00311571 | Completed Phase 1

• 1 other identifier: MEDES/00-433
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Simulation of Weightlessness by Anti-Orthostatic Long Term Bed Rest

Keywords

bedrest; spaceflight; Weightlessness; Countermeasure

Outcome Measures

Primary Outcomes (24)

• 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

Interventions

Ethidronate DRUG

Physical training BEHAVIORAL

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre National d'Etudes Spatiales: lead
• European Space Agency: collaborator
• National Space Development Agency, Japan: collaborator

Study Sites (1)

Medes-Imps

Toulouse, 31405, France

Location

Related Publications (10)

• Rittweger J, Frost HM, Schiessl H, Ohshima H, Alkner B, Tesch P, Felsenberg D. Muscle atrophy and bone loss after 90 days' bed rest and the effects of flywheel resistive exercise and pamidronate: results from the LTBR study. Bone. 2005 Jun;36(6):1019-29. doi: 10.1016/j.bone.2004.11.014. Epub 2005 Apr 2.

  PMID: 15811637 RESULT

• Watanabe Y, Ohshima H, Mizuno K, Sekiguchi C, Fukunaga M, Kohri K, Rittweger J, Felsenberg D, Matsumoto T, Nakamura T. Intravenous pamidronate prevents femoral bone loss and renal stone formation during 90-day bed rest. J Bone Miner Res. 2004 Nov;19(11):1771-8. doi: 10.1359/JBMR.040811. Epub 2004 Aug 23.

  PMID: 15476576 RESULT

• Rittweger J, Felsenberg D. Patterns of bone loss in bed-ridden healthy young male subjects: results from the Long Term Bed Rest Study in Toulouse. J Musculoskelet Neuronal Interact. 2003 Dec;3(4):290-1; discussion 292-4. No abstract available.

  PMID: 15758301 RESULT

• Gallagher P, Trappe S, Harber M, Creer A, Mazzetti S, Trappe T, Alkner B, Tesch P. Effects of 84-days of bedrest and resistance training on single muscle fibre myosin heavy chain distribution in human vastus lateralis and soleus muscles. Acta Physiol Scand. 2005 Sep;185(1):61-9. doi: 10.1111/j.1365-201X.2005.01457.x.

  PMID: 16128698 RESULT

• Rudnick J, Puttmann B, Tesch PA, Alkner B, Schoser BG, Salanova M, Kirsch K, Gunga HC, Schiffl G, Luck G, Blottner D. Differential expression of nitric oxide synthases (NOS 1-3) in human skeletal muscle following exercise countermeasure during 12 weeks of bed rest. FASEB J. 2004 Aug;18(11):1228-30. doi: 10.1096/fj.03-0792fje. Epub 2004 Jun 4.

  PMID: 15180967 RESULT

• Trappe S, Trappe T, Gallagher P, Harber M, Alkner B, Tesch P. Human single muscle fibre function with 84 day bed-rest and resistance exercise. J Physiol. 2004 Jun 1;557(Pt 2):501-13. doi: 10.1113/jphysiol.2004.062166. Epub 2004 Apr 2.

  PMID: 15064323 RESULT

• Belin de Chantemele E, Pascaud L, Custaud MA, Capri A, Louisy F, Ferretti G, Gharib C, Arbeille P. Calf venous volume during stand-test after a 90-day bed-rest study with or without exercise countermeasure. J Physiol. 2004 Dec 1;561(Pt 2):611-22. doi: 10.1113/jphysiol.2004.069468. Epub 2004 Aug 26.

  PMID: 15331681 RESULT

• Belin de Chantemele E, Blanc S, Pellet N, Duvareille M, Ferretti G, Gauquelin-Koch G, Gharib C, Custaud MA. Does resistance exercise prevent body fluid changes after a 90-day bed rest? Eur J Appl Physiol. 2004 Aug;92(4-5):555-64. doi: 10.1007/s00421-004-1121-6. Epub 2004 May 29.

  PMID: 15170571 RESULT

• Reeves NJ, Maganaris CN, Ferretti G, Narici MV. Influence of simulated microgravity on human skeletal muscle architecture and function. J Gravit Physiol. 2002 Jul;9(1):P153-4.

  PMID: 15002526 RESULT

• Belavy DL, Ohshima H, Rittweger J, Felsenberg D. High-intensity flywheel exercise and recovery of atrophy after 90 days bed--rest. BMJ Open Sport Exerc Med. 2017 Jul 24;3(1):e000196. doi: 10.1136/bmjsem-2016-000196. eCollection 2017.

  PMID: 28761699 DERIVED

MeSH Terms

Interventions

Physical Conditioning, Human

Intervention Hierarchy (Ancestors)

Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jacques Bernard, Dr

  MEDES - IMPS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: April 4, 2006
• First Posted: April 6, 2006
• Study Start: August 1, 2001
• Study Completion: June 1, 2003
• Last Updated: September 4, 2006

Record last verified: 2006-04

Locations

FR (1)