Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06544213
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-07-25
Brief Title:
A 60 Days Head Down Tilt Bedrest With Artificial Gravity and Cycling Exercise on 24 Healthy Male BRACE
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Controlled Study on 24 Healthy Male Volunteers Evaluating the Effects of Centrifugation and Exercise to Prevent the Deconditioning Induced by 60 Days of Head-down Bedrest Used as a Ground-based Model to Mimic Weightlessness
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BRACE
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 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
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
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 changes that may affect the performance of astronauts These physiological changes are now better known prolonged exposure to weightlessness can lead to significant loss of bone and muscle mass strength cardiovascular and sensory-motor deconditioning immune hormonal and metabolic changes
Moreover recently a new suite of physiological adaptations and consequences of space flight has been acknowledged Indeed after long flights some astronauts present persistent ophthalmologic changes mostly a hyperopic shift an increase in optic nerve sheath diameter and occasionally a papillary oedema now defined by National Aeronautics and Space Administration NASA as Spaceflight-Associated Neuro-ocular Syndrome SANS Some of these vision changes remain unresolved for years post-flight This phenomenon has most likely existed since the beginning of human space flight but is just recently being recognized as a major consequence of adaptation to microgravity
Overall spaceflight induces physiological multi-system deconditioning which may impact astronauts efficiency and create difficulties upon their return to normal gravity Understanding the underlying mechanisms of these processes and developing efficient countermeasures to prevent limit or reverse this deconditioning remain important challenges and major priorities for manned space programs
The space agencies are actively engaged in studying the physiological adaptation to space environment through studies on board the International Space Station ISS but also on the ground Indeed considering the limited number of flight opportunities the difficulties related to the performance of in-flight experiments operational constraints for astronauts limited capabilities of in-flight biomedical devices ground-based experiments simulating the effects of weightlessness are used to better understand the mechanisms of physiological adaptation design and validate the countermeasures
Different methods are used to simulate microgravity on Earth However two approaches -6 head-down bed rest HDBR and dry immersion DI have provided possibilities for long-term exposures with findings closest to those seen with a weightless state They produce changes in body composition including body fluid redistribution cardiovascular and skeletal muscle characteristics that resemble the effects of microgravity One of the advantages of the HDBR model is that it has now been used in a great number of studies internationally and its effects have long been described and compared with those of microgravity and spaceflight Long-term bedrest is the gold-standard method for studying the effects of weightlessness and to test countermeasures
The HDBR as the name implies implicates a long from several weeks to a year stay in the supine position the head tilted down by -6 from the horizontal plane HDBR is the most frequently used ground-based simulation for gravitational unloading of the human body in western countries
During human space missions the current most effective countermeasure is physical exercise However it is both time-consuming and not completely satisfactory One of the solutions for this is to combine physical exercise with artificial gravity with the use of a short-arm human centrifuge SAHC This study proposes to test the effectiveness of a countermeasure protocol combining Artificial Gravity AG with a cycling exercise and to compare it with only a cycling exercise and with a complete lack of physical exercise
Moreover recently a new suite of physiological adaptations and consequences of space flight has been acknowledged Indeed after long flights some astronauts present persistent ophthalmologic changes mostly a hyperopic shift an increase in optic nerve sheath diameter and occasionally a papillary oedema now defined by National Aeronautics and Space Administration NASA as Spaceflight-Associated Neuro-ocular Syndrome SANS Some of these vision changes remain unresolved for years post-flight This phenomenon has most likely existed since the beginning of human space flight but is just recently being recognized as a major consequence of adaptation to microgravity
Overall spaceflight induces physiological multi-system deconditioning which may impact astronauts efficiency and create difficulties upon their return to normal gravity Understanding the underlying mechanisms of these processes and developing efficient countermeasures to prevent limit or reverse this deconditioning remain important challenges and major priorities for manned space programs
The space agencies are actively engaged in studying the physiological adaptation to space environment through studies on board the International Space Station ISS but also on the ground Indeed considering the limited number of flight opportunities the difficulties related to the performance of in-flight experiments operational constraints for astronauts limited capabilities of in-flight biomedical devices ground-based experiments simulating the effects of weightlessness are used to better understand the mechanisms of physiological adaptation design and validate the countermeasures
Different methods are used to simulate microgravity on Earth However two approaches -6 head-down bed rest HDBR and dry immersion DI have provided possibilities for long-term exposures with findings closest to those seen with a weightless state They produce changes in body composition including body fluid redistribution cardiovascular and skeletal muscle characteristics that resemble the effects of microgravity One of the advantages of the HDBR model is that it has now been used in a great number of studies internationally and its effects have long been described and compared with those of microgravity and spaceflight Long-term bedrest is the gold-standard method for studying the effects of weightlessness and to test countermeasures
The HDBR as the name implies implicates a long from several weeks to a year stay in the supine position the head tilted down by -6 from the horizontal plane HDBR is the most frequently used ground-based simulation for gravitational unloading of the human body in western countries
During human space missions the current most effective countermeasure is physical exercise However it is both time-consuming and not completely satisfactory One of the solutions for this is to combine physical exercise with artificial gravity with the use of a short-arm human centrifuge SAHC This study proposes to test the effectiveness of a countermeasure protocol combining Artificial Gravity AG with a cycling exercise and to compare it with only a cycling exercise and with a complete lack of physical exercise
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None