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MISSION/STUDY INFORMATION

Ground Based Study:    Campaign 3
Program:
Ground
Spacecraft/Location:
UTMB FARU
Launch/Start Date:
02/20/2005
Landing/End Date:
04/14/2010
Duration:
5 years, 1 month, 25 days

Description
This study was conducted at the Flight Analogs Research Unit (FARU) located at the University of Texas Medical Branch (UTMB) in Galveston, Texas and consisted of eight phases (C3A, B, C, D, E, F, G, and H). Campaign 3 was conducted under standard conditions with controlled diet. The bed rest campaign included a 13 day ambulatory phase immediately followed by a 60 or 90 day period of 6 degree head-down tilt, and completed with a 14 day post reconditioning and ambulatory recovery phase.

Campaign 3 began on February 20, 2005 and ended with the release of the C3H subject on April 14, 2010. The study was active for 1941 calendar days and completed a total of 3422 study days (the latter number includes all enrolled subjects). The study enrolled a total of 52 subjects; of those, 23 subjects completed the study, 17 were dismissed early, 10 were evacuated, and two were screen failures. Males accounted for 14 of the completed subjects and females accounted for nine. The overall retention rate for the study was 44%. This rate is due to 10 subjects that were evacuated in response to hurricanes Rita and Ike. The retention rate for subjects that reached the in-phase portion (head down tilt phase) of the study was 59%.

Campaign 3 follows the Flight Analog Project (FAP) guidelines for standard conditions of bed rest, and FAP Standard Measures collection, with modifications to achieve inter-study compatibility and facilitate the implementation of individual research protocol objectives. The standard measures were integrated with the peer-reviewed science requirements on a noninterference basis. The Standard Measures protocols used by FAP were previously reviewed and approved by the JSC Committee for the Protection of Human Subjects (CPHS) and the UTMB Institutional Review Board (IRB).

Bed Rest Standard Conditions Overview

  1. The room temperature (72 ± 2 ºF) and humidity (70 ± 5%) was maintained by FARU.
  2. Subject light/dark cycle was strictly enforced. Subjects were awoken at 06:00 and room lights were extinguished at 22:00 (military time) 7 d/wk. Napping was not allowed.
  3. Pre-bed rest (ambulatory) phase of 11 to 15 days
  4. Bed rest phase of up to 30 days at 6 degrees head-down tilt
  5. Post-bed rest (recovery) phase of 14 days
  6. Daily 24-hour urine collection
  7. Daily iron supplementation for female subjects
  8. Daily vitamin D supplementation during the in-bed phase. Supplementation was administered daily during the pre-bed rest phase if the subject had a low vitamin D level during screening.
  9. Colace was given daily during bed rest.
  10. Personal hygiene for subjects includes showers and sponge baths, performed as needed, with the assistance of the nursing staff.

Phase C3A Synopsis
Phase C3A began on February 2, 2005, and ended on June 21, 2005. Subjects participated in 11 days of the pre-bed rest phase, 90 days of the in-bed rest phase, and 14 days of the post-bed rest phase. A total of six subjects were admitted into the study; of these, four completed the study and two were dismissed. This phase continued the ongoing collection of Bed Rest Standard Measures as previously implemented in Campaign 1 and included investigations by five principal investigators (PIs): Ferrando/Wolfe, Meck, Roberts, Rubin, and Ray.

Phase C3B Synopsis
Phase C3B had the same numbers of study days as described for Phase C3A. Phase C3B began on July 17, 2005 and ended on September 20, 2005. A total of six subjects were admitted into the study. Four subjects were evacuated in response to Hurricane Rita and two were dismissed for medical reasons. These subjects did not successfully completed Phase C3B. This phase continued the ongoing collection of Standard Measures and included investigations with the following changes from Phase C3A: the addition of magnetic resonance imaging (MRI) to Dr. Rubin’s complement of tests and the removal of the Glucose Breath Test, Urea Breath Test, Performance Testing, and Actilight watch.

Phase C3C Synopsis
Phase C3C began on April 2, 2006, and ended on September 9, 2006. Subjects participated in 13 days of the pre-bed rest phase, 90 days of the in-bed rest phase, and 14 days of the post-bed rest phase. A total of two subjects were admitted and both subjects successfully completed the study. This phase continued the ongoing collection of Standard Measures, a change from Phase C3B being the addition of peripheral quantitative computed tomography (pQCT) to the Standard Measures complement. Phase C3C also included investigations with the following changes from Phase C3B: the removal of PIs Roberts and Ray.

Phase C3D Synopsis
Phase C3D had the same numbers of study days as described in Phase C3C; it began on January 17, 2007, and ended on June 14, 2008. A total of 12 subjects were admitted to the study. Seven subjects completed; three subjects were dismissed, and two subjects failed admission screening tests. This phase continued the ongoing collection of Standard Measures. Changes from C3C being the addition of Sublingual Scrape to the Nutritional Assessment testing and Serum Pregnancy tests to Standard Measures complement. Phase C3D also included investigations with the following changes from Phase C3C: the removal of PIs Ferrando and Wolfe.

Phase C3E Synopsis
Phase C3E had the same numbers of study days as described in Phase C3D; it began on March 3, 2008, and ended on August 26, 2008. A total of six subjects were admitted to the study. Two subjects completed the study and four were dismissed. This phase continued the ongoing collection of Standard Measures. Changes from Phase C3D being the removal of the Neuroendocrine and Cardiovascular Response to Tilt and the Functional Neurological Assessment (Balance) tests from day BR60. Phase C3E also included investigations with the following changes from Phase C3D: the removal of PI Rubin’s complement of testing, which included MRI, Ultrasound, and QCT testing.

Phase C3F Synopsis
Phase C3F had the same numbers of study days as described in Phase C3E; it began on June 13, 2008, and ended September 11, 2009. A total of eight subjects were admitted to the study. Six subjects were evacuated in response to Hurricane Ike and two subjects were dismissed. This phase continued the ongoing collection of Standard Measures. Changes from Phase C3E were the collection of additional blood volume for Neuroendocrine and Cardiovascular Response to Tilt. Phase C3F also included investigations with the following changes from Phase C3E: the addition of PI Soller’s Non-Invasive Near Infrared Spectroscopy testing.

Phase C3G Synopsis
Phase C3G had the same numbers of study days as described in Phase C3F; it began on February 8, 2008, and ended on November 21, 2009. The total number of in-bed rest study days for this phase was reduced from 90 to 60 days; however, the durations of the pre- and post-bed rest periods remained the same at 13 and 14 respectively. A total of 11 subjects were admitted into the study. Seven subjects completed the study successfully and four were dismissed. Phase C3G continued the ongoing collection of Standard Measures. Changes from phase C3F were the addition of vitamin D supplement and the removal of pQCT, WINSCAT and Lactulose/Acetaminophen. Phase C3G also included investigations with the following changes from Phase C3F: PI Platts’ Gender Differences study complement of Phenylephrine / Nitroprusside, Dorsal Foot Vein, and Dorsal Hand Vein testing were removed during this phase.

Phase C3H Synopsis
Phase C3H had the same numbers of study days as described in Phase C3G; it began on January 18, 2010, and ended on April 14, 2010. One subject was admitted and completed the study successfully. Phase C3H continued the ongoing collection of Standard Measures; changes from C3G were the addition of pQCT, Eye Exam, Optical Coherence Tomography Testing, 3-Tesla MRI, and Review of Systems Questionnaire.

Standard Measures data were collected on the subjects participating in C3. Some of these data were utilized to monitor the medical condition of the subjects, improve the descriptions of the physiologic responses of humans to bed rest, compare effects of bed rest with those of space flight, and provide context for data that are collected to evaluate a potential countermeasure. Many of these tests are identical or substantially similar to those conducted on the crews of the International Space Station as part of their medical evaluation. The Standard Measures protocols are further described in the specific experiment sections. Additional testing was performed to assess different physiological systems and their response to bed rest.

In addition to the Standard Measures testing, six external principal investigations were included with the Campaign 3 science requirements:

  • Combined Effects of Nutritional and Exercise Countermeasures (BEDREST2013)
    (PI: Arny A. Ferrando, Ph.D., Professor, Department of Surgery, University of Texas Medical Branch, Galveston, Texas)

  • Gender Differences in Bedrest: Autonomic and Neuroendocrine Changes and Vascular Responses in Lower and Upper Extremities (BEDREST0543)
    (PI: Jan Meck, Ph.D., and Steve, Platts, Ph.D., NASA/Johnson Space Center, Houston, TX)

  • Human Cerebral Cortex Plasticity in Response to Long-term Bed rest as an Analog to Microgravity (NSBRI20010036)
    (PI: Donna R. Roberts, MD., Neuroradiology Section, Department of Radiology, University of California at San Francisco, San Francisco, California 94143)

  • Retention of Skeletal, Musculature and Postural Status with a Non-Invasive, Extremely Low-Level Mechanical Signal: A Ground-Based Evaluation of Efficacy (BEDREST0035)
    (PI: Clinton T. Rubin, Ph.D., Department of Biomedical Engineering, State University of New York, Stony Brook, NY 11794-2580)

  • Ultrasonic Bone Stimulation: Countermeasure to Orthostatic Intolerance (BEDREST0078)
    (PI: Chester A. Ray, Ph.D., Professor of Medicine and Cellular and Molecular Physiology, Department of Medicine, Division of Cardiology, The Pennsylvania State College of Medicine, Hershey, Pennsylvania)

  • Near Infrared Spectroscopy (NIRS) and Echocardiography (NIRS)
    (PI: Soller, Babs R, Ph.D. University of Massachusetts Medical School, Worcester, Masschusetts)
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    Experiments on this Mission