Status:
ACTIVE_NOT_RECRUITING
A 60 Days Head Down Tilt Bedrest With Artificial Gravity and Cycling Exercise on 24 Healthy Male (BRACE)
Lead Sponsor:
Centre National d'Etudes Spatiales
Collaborating Sponsors:
European Space Agency
MEDES - IMPS
Conditions:
Simulated Microgravity by Head Down Tilt Bedrest
Weightlessness
Eligibility:
MALE
20-45 years
Phase:
NA
Brief Summary
The objective of this study is to investigate whether a cycling exercise coupled with artificial gravity via a short-arm human centrifuge helps to prevent and / or reduce the deleterious effects induc...
Detailed Description
Space flights have shown the possibilities and limitations of human adaptation to space. For the last 60 years, results have shown that the space environment and microgravity in particular, cause chan...
Eligibility Criteria
Inclusion
- Healthy male volunteer (see below the description of medical tests and laboratory analysis performed at the selection visit)
- Aged 20 to 45 years
- No overweight nor excessive thinness with BMI (weight kg/ height m2) between 20 and 27 kg/m2
- Height between 158 and 190 cm
- Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination): in particular, free from any chronic disease or any acute infectious disease or cardiovascular, neurological, of the ear, nose, throat (especially orthostatic hypotension and vestibular disorders), orthopaedic or musculoskeletal disorders
- Good mental health: tests and psychological interview will be held by a specialist in extreme environment
- Fitness level assessment: 35 mL/min/kg \< VO2max \< 55 mL/min/kg
- Non active smokers
- No alcohol or drug dependence, and no medical treatment
- Covered by a Health Insurance System
- Having signed the information consent
- Free of any engagement during the study
Exclusion
- Any history or presence of clinically relevant cardiovascular, neurological or ear, nose, throat disease, any chronic disease; any acute infectious disease. Particularly:
- Symptomatic orthostatic hypotension whatever the decrease in blood pressure, or asymptomatic postural hypotension defined by a decrease in systolic blood pressure equal to or greater than 20 mmHg within 3 minutes when changing from the supine to the standing position,
- Cardiac rhythm disorders,
- Hypertension,
- Chronic back pains,
- Vertebral fracture, scoliosis, or herniated disc,
- Glaucoma,
- Self-reported hearing problems,
- Vestibular disorders
- History of migraines,
- History of hiatus hernia or gastro-esophageal reflux,
- History of thyroid dysfunction, renal stones, diabetes,
- History of head trauma,
- Abnormal result for lower limbs echo-doppler,
- History of genetic muscle and bone diseases of any kind,
- Past records of thrombophlebitis, family history of thrombosis or positive response in thrombosis screening procedure (anti thrombin III, S-protein, C-protein, factor V Leiden mutation and the mutation 20210 of the prothrombin gene),
- Bone mineral density: T-score ≤ -1.5,
- Poor tolerance to blood sampling,
- Having given whole blood (more than 7 mL/kg) in a period of 8 weeks or less before the start of the experiment, or having given whole blood more than 2 times in the past year,
- Significant history of allergy, especially no dermatological or food allergy,
- Significant anomaly detected in the biological analysis,
- Positive reaction to any of the following tests: hepatitis A immunoglobulin, hepatitis B antigen, anti hepatitis C antibodies, anti Human Immunodeficiency Virus 1+2 antibodies,
- Vegetarian or vegan,
- Refusal to give permission to contact his general practitioner,
- Subject who, in the judgment of the investigator, is likely to be non-compliant during the study, or unable to cooperate because of a language problem or poor mental development,
- Subject already participating or in the exclusion period of a clinical research,
- Subject who has received more than 4500 Euros within 12 months for being a research subject,
- Subject who cannot be contacted in case of emergency,
- Subject who had the two knees injured
- MRI contraindications
- History or active claustrophobia
- Osteosynthesis material, presence of metallic implants or any other contra-indication for MRI
- Vulnerable persons according to French law (L1121-5 to L1121-8) :
- Persons deprived of their liberty by an administrative or judicial decision
- Persons under involuntary psychiatric care
- Persons admitted in a health or social establishment for purposes other than research
- Minors
- Adults subject to legal protection (subject under guardianship or trusteeship) or unable to express their consent
Key Trial Info
Start Date :
February 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2026
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06544213
Start Date
February 6 2023
End Date
April 30 2026
Last Update
December 18 2025
Active Locations (1)
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1
MEDES-Institut de Médecine et Physiologie Spatiale
Toulouse, France, France, 31400