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 RaumfahrtmedizinLinder Höhe51147 KölnGermany
- 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 RaumfahrtmedizinDr. Edwin MulderLinder Höhe51147 KölnGermany
- 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 RaumfahrtmedizinAndrea NitscheLinder Höhe51147 KölnGermany
- 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 RaumfahrtmedizinDr. Edwin MulderLinder Höhe51147 KölnGermany
- 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 CenterNASA Parkway2101 Houston, TexasUnited 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 CentreKeplerlaan 12201 NordwjikNetherlands
- 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 RaumfahrtmedizinLinder Höhe51147 KölnGermany
- 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 NordrheinTersteegenstr. 940474 DüsseldorfGermany
- 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
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