Long-term Bed Rest Study 2018 Artificial Gravity Bed Rest with European Space Agency

Organizational Data

DRKS-ID:
DRKS00015677
Recruitment Status:
Recruiting complete, study complete
Date of registration in DRKS:
2018-10-02
Last update in DRKS:
2023-08-14
Registration type:
Prospective

Acronym/abbreviation of the study

AGBRESA-Study

URL of the study

No Entry

Brief summary in lay language

Human spaceflight is currently entering the next phase of space exploration, namely towards the Moon and Mars. Linked to such ambitious goals are - by nature – physical, psychological and technological challenges which become increasingly difficult to understand and overcome with longer-duration missions: future exploration class missions may last up to several years, exposing astronauts to extreme environmental conditions and physical stressors that could cause major issues to both health and performance. Currently, some of these issues are considered as showstoppers for long-duration exploration missions with human crews. To safeguard astronauts’ health, well-being and working efficiency, a comprehensive strategy to mitigate various risks is therefore required, including development of so-called countermeasures to reduce adverse responses to stressors stemming from exposure to the space environment. Over the past 50 years of human spaceflight experience, a palette of countermeasures has been developed and tested, but they have had only limited success. This may be explained by the fact that currently applied countermeasures mitigate harmful responses of specific systems of the human body. Future countermeasures, therefore, have to be approached in an interdisciplinary manner. Because all physiological systems are challenged through the application of artificial gravity (AG) by centrifugation, it has been considered that AG has the unique feature of being a multi-system countermeasure for mitigating the effects of weightlessness. The primary objective of the AGBRESA bed rest study is to compare the protective effects of one single daily bout (30 min) versus multiple daily bouts of AG (6 x 5 min) on physiological functions that are affected by simulated weightlessness. A secondary objective is to document the user’s point of view, such as subjective rating of comfort/discomfort, perceived exhaustion, perceived benefits, and any other psychological issues associated with the AG protocols. The research in this bed rest study is proposed and will be performed by international established research teams and characterizes changes in physiological and psychological systems; systems of interest include, but are not limited to musculoskeletal, sensorimotor, cardiovascular, cerebrovascular, ocular, functional performance, cognition and behavioral health.

Brief summary in scientific language

Weightlessness causes multiple physiological changes in the human organism. The absence of gravity results in a loss of mechanical loading of the muscles and bones, a redistribution of fluids in the body and changes in the acid-base balance (mostly for dietary reasons), which for their part lead to gradual reduction of bone, cartilage and muscle mass, mainly in the lower extremities; deconditioning of the cardiovascular system; alterations of metabolism and cognitive performance. Aware of these changes, spaceflight missions were soon complemented with preventive measures, or ‘countermeasures’ in the human spaceflight context, to alleviate or completely prevent deconditioning of the human body. However, some 50 years later, the currently employed countermeasures are to some extent still insufficient. Maintenance of astronaut safety and wellbeing is imperative for successful future long-duration spaceflight missions on board the international space station ISS, to the Moon and eventually to Mars. Artificial gravity (AG) generated by centrifugation has the potential to mitigate physiological deconditioning caused by prolonged exposure to weightlessness. Because all physiological systems are challenged through the application of AG, it has been considered that AG has the unique feature of being a multi-system countermeasure for mitigating the effects of weightlessness. While it is obvious that AG cannot address all of the problems associated with long-duration spaceflight, there is scientific consensus that AG offers the potential to address the debilitating problems of bone loss, cardiovascular deconditioning, muscle weakening, sensorimotor and neurovestibular disturbances and regulatory disorders. In contrast to traditional countermeasures, AG can be considered as an integrated countermeasure because it addresses all of these systems at once. Therefore the use of AG might be the best solution for human health protection during human long-duration deep space missions.

Health condition or problem studied

Free text:
Muscular atrophy, bone resorption,Deconditioning of the cardiovascular system, impairment of the vestibular system, impairment of cognitive performance, fluid shifts, eye changes, SANS
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
Intervention Group 1: 6° HDBR with supine centrifugation at +1Gz at the center of mass for 30 minutes continuous per day.
Arm 2:
Intervention group 2: 6° HDBR with supine centrifugation at +1Gz at the center of mass for 6 bouts of 5 minutes per day (sessions 2-6 are separated by 5 minutes of rest).
Arm 3:
control Group: 6° HDBR with no centrifugation (passive control).

Endpoints

Primary outcome:
s. Appendix "endpoints"
Secondary outcome:
s. Appendix "endpoints"

Study Design

Purpose:
Basic research/physiological study
Allocation:
Randomized controlled study
Control:
  • Active control (effective treatment of control group)
  • Control group receives no treatment
Phase:
N/A
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
No
Assignment:
Parallel
Sequence generation:
No Entry
Who is blinded:
No Entry

Recruitment

Recruitment Status:
Recruiting complete, study complete
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Monocenter study
Recruitment location(s):
  • Other Deutsches Zentrum für Luft- und Raumfahrt, Institut für Luft- und Raumfahrtmedizin Köln

Recruitment period and number of participants

Planned study start date:
2019-03-25
Actual study start date:
2019-03-25
Planned study completion date:
No Entry
Actual Study Completion Date:
2021-12-08
Target Sample Size:
24
Final Sample Size:
24

Inclusion Criteria

Sex:
All
Minimum Age:
24 Years
Maximum Age:
55 Years
Additional Inclusion Criteria:
Physically and mentally healthy test subjects that are able and declare their willingness to participate in the entire study and successfully passed the psychological and medical screening - Aged between 24 and 55 years old with a Body Mass Index (BMI) of 19 - 30 kg/m2, height between 153 -190 cm - Non-smoker, for at least six months before the start of the study - Capable of completing the study - Willing to stay in bed with or without weight-bearing (artificial gravity) for 60 days - Demonstrable medical insurance and official certificate of absence of criminal record - Demonstrable dentist certificate

Exclusion Criteria

- Drug, medication or alcohol abuse (regular consumption of more than 20-30 g alcohol/day)* - A requirement for any prescription medications - Vegetarian, vegan (during the study) - Migraine, chronic headache - Insomnia or other sleep disorders - Previous psychiatric illness - Claustrophobia - Increased intraocular pressure - Any eye disorder that could significantly impact or jeopardize visual function - Hyperopia > +5.0 Diopters - Myopia > - 6 Diopters - Astigmatism > 3 Diopters - History of laser surgery, glaucoma and retinal surgery - Hiatus hernia - Gastro-oesophageal reflux - Gastrointestinal stenosis, dysphagia - Current or history of chronic bowel disease - Diabetes mellitus - Rheumatic illness - Current or a history of (chronic) pulmonary disease - Current muscle or joint disease or disorder - History of prolapsed intervertebral disc - Chronic back complaints - Bone fractures less than 1 year prior to study - Kidney disorder: deviations from normal values for creatinine in plasma. Deviations from normal values (Normal values for creatinine in plasma < 1.20 mg/dl)** and eGFR*** - History of kidney stones - History of (chronic) cystitis, hydronephrosis, pyelonephritis - Anaemia: Hb under normal values. (Normal values of Hb for men: 13.0-17.5 g/dl; women 12.0-16.0 g/dl)** - Elevated risk of thrombosis **** - Pronounced orthostatic intolerance (< 10 min standing and/or not able to withstand artificial gravity) - History of elevated intracranial pressure and associated central nervous disorders - Current or history of hemorrhagic diathesis or coagulations disorders - History of spinal cord disease, including radiculopathy, myelopathy, or neuropathy - History of skull/cranial surgeries - History of adverse events to local anesthesia - An abnormal androgen or estrogen status (tested only upon speculation) - Female candidate is pregnant - Female candidate is on oral contraceptives or contraceptive patch up to 4-6 months prior to study start - Female candidate is in menopause or post-menopause, or is on hormone replacement therapy - Female subjects without a normal length menstrual cycle (20-36 days) - Inability or unwillingness to perform the required tests - A medical or orthopedic condition that would preclude bed rest or exercise, as is determined by the examining and overseeing physician of the bed rest study - Not within two standard deviations of normal bone mineral density (measured by dual-energy x-ray absorptiometry) for hip and lumbar spine based on T-score (young adult-peak bone mass, Caucasian, sex, but not age-adjusted) - Metal implants (or objects like metallic slivers in the eyes, or bullets or shrapnel in the body) or other kinds of bone synthesis materials that are not well-fixed; tattoos or permanent make-up incompatible with MRI - Participation in a (clinical) study within the last 3 months before start of this study that confounds participation in the AGBRESA study - Known history of vertigo, nystagmus, neurological conditions, vestibular or gait disorders - Previous heart surgery - History of cerebrovascular or brain disease, tumor, injury, surgery or malformation - Disorders of CSF circulation (i.e. hydrocephalus, idiopathic intracranial hypertension) - Tinnitus; sensorineural hearing loss > 30 dB, or implanted hearing device - Known Chiari-malformation - History of fracture(s) at proximal femur (hip area), less than 2 years, and/or with remaining deficit and/or implants - Any other condition, which makes the test subject unsuitable for study inclusion in the opinion of the project team

Addresses

Primary Sponsor

Address:
DLR - Institut für Luft- und Raumfahrtmedizin
Linder Höhe
51147 Köln
Germany
Telephone:
+492203601-0
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
http://www.dlr.de/me/
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Address:
DLR - Institut für Luft- und Raumfahrtmedizin
Dr. Edwin Mulder
Linder Höhe
51147 Köln
Germany
Telephone:
+49 2203 601-3062
Fax:
+49 2203-61159
Contact per E-Mail:
Contact per E-Mail
URL:
http://www.dlr.de/me/

Contact for Public Queries

Address:
DLR - Institut für Luft- und Raumfahrtmedizin
Andrea Nitsche
Linder Höhe
51147 Köln
Germany
Telephone:
02203-601-3472
Fax:
+49 2203 63030
Contact per E-Mail:
Contact per E-Mail
URL:
http://www.dlr.de/me/

Principal Investigator

Address:
DLR - Institut für Luft- und Raumfahrtmedizin
Dr. Edwin Mulder
Linder Höhe
51147 Köln
Germany
Telephone:
+49 2203 601-3062
Fax:
+49 2203-61159
Contact per E-Mail:
Contact per E-Mail
URL:
http://www.dlr.de/me/

Sources of Monetary or Material Support

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)

Address:
NASA Johnson Space Center
NASA Parkway
2101 Houston, Texas
United States
Telephone:
+1 281-483-0123
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
https://www.nasa.gov/centers/johnson/home/index.html

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)

Address:
Europäische Raumfahrtagentur - ESAESTEC- European Space Research and Technology Centre
Keplerlaan 1
2201 Nordwjik
Netherlands
Telephone:
+31 71 565 65 65
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
http://www.esa.int/About_Us/ESTEC/ESTEC_European_Space_Research_and_Technology_Centre

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)

Address:
DLR - Institut für Luft- und Raumfahrtmedizin
Linder Höhe
51147 Köln
Germany
Telephone:
+492203601-0
Fax:
No Entry
Contact per E-Mail:
Contact per E-Mail
URL:
http://www.dlr.de/me/

Ethics Committee

Address Ethics Committee

Address:
Ethikkommission der Ärztekammer Nordrhein
Tersteegenstr. 9
40474 Düsseldorf
Germany
Telephone:
+49-211-43021581
Fax:
+49-211-43021585
Contact per E-Mail:
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Vote of leading Ethics Committee
Date of ethics committee application:
2018-04-27
Ethics committee number:
2018143
Vote of the Ethics Committee:
Approved
Date of the vote:
2018-09-17

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
Endponis AGBRESA
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry