NCT00891449

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 1, 2009

Completed
2.2 years until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

November 17, 2015

Status Verified

November 1, 2015

Enrollment Period

3.4 years

First QC Date

April 30, 2009

Last Update Submit

November 13, 2015

Conditions

Weightlessness

Keywords

space flight simulation studymedical research studybed restmicrogravityweightlessnessThe effects of long duration microgravity on humans

Eligibility Criteria

Age24 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Community sample

You may qualify if:

  • US Citizen
  • Must be able to pass physical

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

Related Publications (1)

  • 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.

    PMID: 31194764DERIVED

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood, Urine

Study Officials

  • Dr. Ronita L Cromwell, Ph.D.

    National Aeronautics and Space Administration (NASA)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2009

First Posted

May 1, 2009

Study Start

July 1, 2011

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

November 17, 2015

Record last verified: 2015-11

Locations

US(1)