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WeightlessnessFAPNCT00891449

Space Flight Simulation to Study Effects of Micro-gravity Through Bed Rest

An observational study of Weightlessness, run by National Aeronautics and Space Administration (NASA) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Space flight simulation study to study effects of microgravity through bedrest coupled with flight exercise counter-measures. Read more about this study

Who is it for?
Ages 24 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Weightlessness
How many people
20 participants
Where
1 siteUnited States
Study dates
Jul 2011to Dec 2014
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 24 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: Community sample

Who may be able to join

  • US Citizen
  • Must be able to pass physical

Who cannot join

  • tobacco use
  • menopausal
  • prescription drug use
  • food allergies
  • joint injuries
  • Thrombosis
Show all 9Show fewer
  • Reflux
  • High blood pressure
  • Diabetes

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Texas Medical Branch

    Galveston, Texas, 77555

Other trials in United States

About this study

Official title: Countermeasure and Functional Testing Study (CFT-70)

Space flight simulation study to study effects of microgravity through bedrest coupled with flight exercise counter-measures.

Read the detailed 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.

Conditions
Weightlessness
Keywords
space flight simulation study, medical research study, bed rest, microgravity, weightlessness, The effects of long duration microgravity on humans

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2009 (estimated)
  2. Study startJul 2011
  3. Primary completionDec 2014
  4. Study completionDec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00891449
Sponsor's protocol ID
SA-06-2770
Acronym
FAP
Status last verified
Nov 2015
First submitted
30 Apr 2009
Last updated
17 Nov 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Dillon EL, Soman KV, Wiktorowicz JE, Sur R, Jupiter D, Danesi CP, Randolph KM, Gilkison CR, Durham WJ, Urban RJ, Sheffield-Moore M. Proteomic investigation of human skeletal muscle before and after 70 days of head down bed rest with or without exercise and testosterone countermeasures. PLoS One. 2019 Jun 13;14(6):e0217690. doi: 10.1371/journal.pone.0217690. eCollection 2019.

    PubMed 31194764

Questions about this trial

What is this clinical trial studying?

An observational study of Weightlessness, run by National Aeronautics and Space Administration (NASA) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00891449, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2015.

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