Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00891449 |
| Other study ID # |
SA-06-2770 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
April 30, 2009 |
| Last updated |
November 13, 2015 |
| Start date |
July 2011 |
| Est. completion date |
December 2014 |
Study information
| Verified date |
November 2015 |
| Source |
National Aeronautics and Space Administration (NASA) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: Federal Government |
| Study type |
Observational
|
Clinical Trial Summary
Space flight simulation study to study effects of microgravity through bedrest coupled with
flight exercise counter-measures.
Description:
Flight Analogs/Bed Rest Research Project (FA/BRRP) provides NASA with a ground-based
research platform to complement space research. By mimicking on Earth the conditions of
weightlessness experienced by the human body in space, NASA can test and refine scientific
theories and procedures to develop countermeasures to protect humans from the effects of the
space travel. The use of ground analogs, such as bed rest, are essential because access to
the resources required to conduct studies in space is very limited, and the expense of
studies significantly greater than those conducted using flight analogs. Future space
exploration will challenge NASA to answer many critical questions about how humans can live
and work for extended missions away from Earth.
Flight analog testing is critical to NASA to validate countermeasures, given the few
opportunities to use flight platforms as the Shuttle retires; also, the US has only 1-2
International Space Station (ISS) crewmembers per Expedition. The Flight Analogs/Bed Rest
Research Project is one way NASA will devise ways to ensure astronaut safety and
productivity on extended missions to the moon and Mars.
In the Flight Analogs Project (FAP), volunteers spend many days in a controlled research
environment in the Flight Analog Research Unit (FARU) in Galveston, TX. In the current
campaigns, volunteers will undergo three phases in the bedrest projects: 1) pre-bedrest
baseline testing, 2) a bedrest phase, and 3) the recovery period. Bed rest results in many
physiologic changes similar to those seen in astronauts. Pre bed rest is used to gather
baseline data against which the bed-rest phase data will be compared. Researchers then
monitor how the volunteers' bodies change over the course of the study and how quickly they
recover once they are allowed to resume normal activities. Post bed rest is used to monitor
recovery from bed rest. In longer campaigns, return to the unit for follow-up testing may be
requested after 1, 3, 6, and/or 12 months.
THE COUNTERMEASURE AND FUNCTIONAL TESTING STUDY (CFT) will test the effectiveness of
exercise on loss of muscle, bone and cardiovascular function. Participants will perform an
exercise program in a system called the standalone Zero Gravity Locomotion Simulator (sZLS),
a "vertical treadmill" that removes the weight from the long axis of the body to simulate
exercise as it is done in space. Resistance (weight lifting) exercise will be performed on
special weight machines. Before and after 70 days of bedrest, participants will be tested on
a corresponding set of physiological measures. Specific exercises and intensities are
rotated such that each workout is different, with some days being heavier and some lighter.
Results of the study will help understand which mission tasks might be affected by changes
in physiology during space flight and design countermeasures to prevent or minimize
impairment to these physiological systems
The ALTERNATE COMPRESSION GARMENT STUDY (ACG) will determine effectiveness of compression
garments on regulating blood pressure and other body systems after extended periods of
head-down bed rest. Participants in the experimental group will wear custom-fit compression
garments and undergo evaluation on their response to an upright tilt test and a
corresponding set of physiological measures before and after 14 days of bed rest. These
participants will be compared to another group of participants who did not wear the
compression garments. Results of the study will help scientists determine the time it takes
for the cardiovascular system to re-adapt to upright posture, determine whether wearing
compression garments during recovery is necessary to protect against dizziness and loss of
consciousness often experienced after space missions, and determine the effect of wearing
custom fit compression garments on the amount of time needed to readjust to a normal,
upright posture.
