Ignite Creation Date:
2024-05-05 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00311571
Status:
COMPLETED
Last Update Posted:
2006-09-04
First Post:
2006-04-04
Brief Title:
Toulouse Male Long Term Bed Rest 2001-2002
Sponsor:
Centre National dEtudes Spatiales
Organization:
Centre National dEtudes Spatiales
Study Overview
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 Subjects1Perfecting 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 2Pharmacokinetic Assessment Effects of Position on the Absorption Mechanisms Pharmacokinetics of Paracetamol Used as Model to Study Oral Absorption in Simulated Weightlessness
Status:
COMPLETED
Status Verified Date:
2006-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 induce modifications which may affect the performances of the astronauts These modifications concern in particular the cardiovascular and hormonal systems the muscles the bones the blood and the immune system Other problems may occur during long duration flights such as the problems created by psychological stress due to the confinement or those resulting from the cosmic rays radiation
In view of the fact that space flight opportunities are few experiences simulating the effects of weightlessness experiences are undertaken on the earth in order to better understand the adaptation mechanisms prepare the spaceflights perfect and evaluate corrective methods called counter-measures such as physical exercise or medication to facilitate the astronauts return to base These experiments are also a necessity in view of the difficulties encountered when carrying out certain experiences during the flights due to the presence of too few astronauts on board and to the lack of advanced biomedical devices onboard scanner etc The most common simulation is that of the anti-orthostatic bed rest tilted position with the head slightly under the feet at a -6 angle
Since the current objective is to simulate flights in the International Space Station 3 to 6 months or possible flights to Mars 500 to 1000 days it is mandatory to extend the duration of the simulation experiments This is why three Space Agencies CNES France European Space Agency ESA European Union National Space Development Agency of Japan NASDA Japan decided to join forces and undertake in common such simulation campaigns on ground to best apprehend the adaptation processes to the constraints of the space environment
The 2 main objectives of this experiment are
to study the physiological changes mechanisms during a ground-based experiment simulating long duration spaceflights
to develop and validate preventive methods countermeasures using standard tests
This is why we will test in the present study the effects of an orthostatic bed rest decubitus of 90 days 3 months on the following physiological systems
the bones
the muscles
the cardiovascular system and its control mechanisms
the sleep
the spine
In the absence of gravity the weight of the astronaut and that of the objects disappear completely This induces modifications of the bones and the muscles which can severely affect the astronauts life during the flight and even more when returning to earth This is a fundamental point to study since it may become a limiting factor and even an obstacle to long duration flights This experiment should also permit the test of physical exercise program and of a drug pamidronate AREDIA as counter-measures against the effects of weightlessness on the locomotion system skeleton and muscles
A total of 28 volunteers will participate to this experiment split into three groups Said experiment will spread on 2 years 14 volunteers participating each time The 3 groups are the following
Group physical exercise 9 volunteers
Group drug pamidronate 9 volunteers
Group control 10 volunteers
Members of the groups will be drawn by lot among the participants
Group Exercise exposure of Man to microgravity results in a muscular atrophy which affects the muscles of the lumbar region and those of the lower limbs which are concerned by the standing position and the locomotion During certain flights physical exercise programs have been implemented in order to fight against this muscular atrophy maintain the physical condition required for the mission and prepare the astronauts for their return on earth In the course of the present experiment a physical exercise program will be tested on the 9 volunteers of this group resistance training using both calf and knee extensor muscles with a special devicecalled Fly-Wheel
Group Drug a Man in microgravity is the sole experimental model available to test the rapid occurrence of osteoporosis on a healthy subject Osteoporosis or porous bone appears whenever the rate at which the bone material is replaced falls below that of resorption thus creating a bone fragility and an increased risk of fracture hip spine and wrist essentially It appears generally after menopause when associated with aging and a lack of physical activity The pamidronate Aredia is a drug present on the market since many years used for the treatment of several bone pathologies This drug will be tested on the 9 volunteers of this group to demonstrate its efficiency in treating of bone modifications This drug 60mg will be infused intravenously 14 days before bed rest
Group control this group will serve as reference for the experimentation Volunteers in this group will be without physical exercise and without drug The existence of this group is necessary to be able to compare the results of the 2 types of counter-measures
The experience will be carried out during a 120 days stay a total of 4 months at the Space Clinic and will comprise
1 control ambulatory period of 15 days subjects to report on day before -15 at -1
1 anti-orthostatic -6 bed rest period of 90 days 1 at 90
1 recovery ambulatory period of 15 days subjects to depart the following morning 1 at 15 representing a total of 122 nights spent at the clinic for all volunteers
The assessments will be done by different European and Japanese scientific teamseach one specialising in a specific domain None of the 3 groups of volunteers will be submitted to all experimentation programs
In view of the fact that space flight opportunities are few experiences simulating the effects of weightlessness experiences are undertaken on the earth in order to better understand the adaptation mechanisms prepare the spaceflights perfect and evaluate corrective methods called counter-measures such as physical exercise or medication to facilitate the astronauts return to base These experiments are also a necessity in view of the difficulties encountered when carrying out certain experiences during the flights due to the presence of too few astronauts on board and to the lack of advanced biomedical devices onboard scanner etc The most common simulation is that of the anti-orthostatic bed rest tilted position with the head slightly under the feet at a -6 angle
Since the current objective is to simulate flights in the International Space Station 3 to 6 months or possible flights to Mars 500 to 1000 days it is mandatory to extend the duration of the simulation experiments This is why three Space Agencies CNES France European Space Agency ESA European Union National Space Development Agency of Japan NASDA Japan decided to join forces and undertake in common such simulation campaigns on ground to best apprehend the adaptation processes to the constraints of the space environment
The 2 main objectives of this experiment are
to study the physiological changes mechanisms during a ground-based experiment simulating long duration spaceflights
to develop and validate preventive methods countermeasures using standard tests
This is why we will test in the present study the effects of an orthostatic bed rest decubitus of 90 days 3 months on the following physiological systems
the bones
the muscles
the cardiovascular system and its control mechanisms
the sleep
the spine
In the absence of gravity the weight of the astronaut and that of the objects disappear completely This induces modifications of the bones and the muscles which can severely affect the astronauts life during the flight and even more when returning to earth This is a fundamental point to study since it may become a limiting factor and even an obstacle to long duration flights This experiment should also permit the test of physical exercise program and of a drug pamidronate AREDIA as counter-measures against the effects of weightlessness on the locomotion system skeleton and muscles
A total of 28 volunteers will participate to this experiment split into three groups Said experiment will spread on 2 years 14 volunteers participating each time The 3 groups are the following
Group physical exercise 9 volunteers
Group drug pamidronate 9 volunteers
Group control 10 volunteers
Members of the groups will be drawn by lot among the participants
Group Exercise exposure of Man to microgravity results in a muscular atrophy which affects the muscles of the lumbar region and those of the lower limbs which are concerned by the standing position and the locomotion During certain flights physical exercise programs have been implemented in order to fight against this muscular atrophy maintain the physical condition required for the mission and prepare the astronauts for their return on earth In the course of the present experiment a physical exercise program will be tested on the 9 volunteers of this group resistance training using both calf and knee extensor muscles with a special devicecalled Fly-Wheel
Group Drug a Man in microgravity is the sole experimental model available to test the rapid occurrence of osteoporosis on a healthy subject Osteoporosis or porous bone appears whenever the rate at which the bone material is replaced falls below that of resorption thus creating a bone fragility and an increased risk of fracture hip spine and wrist essentially It appears generally after menopause when associated with aging and a lack of physical activity The pamidronate Aredia is a drug present on the market since many years used for the treatment of several bone pathologies This drug will be tested on the 9 volunteers of this group to demonstrate its efficiency in treating of bone modifications This drug 60mg will be infused intravenously 14 days before bed rest
Group control this group will serve as reference for the experimentation Volunteers in this group will be without physical exercise and without drug The existence of this group is necessary to be able to compare the results of the 2 types of counter-measures
The experience will be carried out during a 120 days stay a total of 4 months at the Space Clinic and will comprise
1 control ambulatory period of 15 days subjects to report on day before -15 at -1
1 anti-orthostatic -6 bed rest period of 90 days 1 at 90
1 recovery ambulatory period of 15 days subjects to depart the following morning 1 at 15 representing a total of 122 nights spent at the clinic for all volunteers
The assessments will be done by different European and Japanese scientific teamseach one specialising in a specific domain None of the 3 groups of volunteers will be submitted to all experimentation programs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None