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Completed
NCT06544213
A 60 Days Head Down Tilt Bedrest With Artificial Gravity and Cycling Exercise on 24 Healthy Male (BRACE)
Conditions: Simulated Microgravity by Head Down Tilt Bedrest, Weightlessness
Sex: Male
Ages: 20 Years – 45 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 24
Sponsor: Centre National d'Etudes Spatiales
Location: MEDES-Institut de Médecine et Physiologie Spatiale Toulouse France
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 induced by 60 days of anti-orthostatic bedrest.
The secondary objective is to investigate whether the combination of a supine cycling exercise with artificial gravity is more effective than the same supine cycling exercise alone in preventing or reducing the effects of head-down bedrest.
During a randomized, 60 day bed rest study, in 24 healthy male adults, the two following aims will be undertaken:
* Fourteen scientific protocols will assess the changes in the cardiovascular, metabolic, musculoskeletal, neuro-sensorial, haematological, and immunological systems.
* In the above-mentioned systems, the comparative potential beneficial effects of the two countermeasure protocols will also be investigated by the scientific protocols and bedrest standard measurements (BSM).
Eligibility Criteria
Inclusion Criteria:
* 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 Criteria:
* 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
Source: ClinicalTrials.gov (NCT06544213). StuddyBuddy aggregates publicly available trial information.