Ignite Creation Date:
2024-07-17 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06492057
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-05-23
Brief Title:
Electromyostimulation EMS of Astronauts in Spaceflight Easymotion-2
Sponsor:
Charite University Berlin Germany
Organization:
Charite University Berlin Germany
Study Overview
Official Title:
ElectroMyoStimulation EMS Body Suit Protocol to Improve Exercise Outcome in Space Missions EasyMotion-2
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Easymotion-2
Brief Summary:
This is a prospective spaceflight study involving an investigational non-risk device called the EasyMotionSkin for whole body electric muscle myo stimulation WB-EMS onboard the International Space Station ISS
The purpose of this study is to show
optimized exercise outcome with EMS in human spaceflight
demonstrate efficacy of EMS as alternative inflight exercise protocol
provide a time-saving and reliable EMS-assisted exercise protocol compliant to astronauts for later use in planetary habitats and future deep space exploration
Eight n8 astronauts on long duration missions will take part in this study This experiment uses the following hardwaresoftware HW SW A EasymotionSkin suit dry electrode muscle stimulation B non-invasive hand-held Myoton device digitized passive muscle stiffness data collection C a customized Myoton body template suit elastic yoga suit with customized anatomical reference labels to aid inflight Myoton data collection on dedicated perforated 2x2 cm small skin fields at 5 different skin measurement points MP neck back shoulder legs
Before and after flight the following tests will be done once Myoton data collection dynamometry strength test magnetic resonance imaging MRI for baseline comparison Researchers will compare data from a non EMS control group non EMS Astronauts retrospective to see if changes of passive muscle stiffness is seen in EMS Astronauts before during and after spaceflight
The purpose of this study is to show
optimized exercise outcome with EMS in human spaceflight
demonstrate efficacy of EMS as alternative inflight exercise protocol
provide a time-saving and reliable EMS-assisted exercise protocol compliant to astronauts for later use in planetary habitats and future deep space exploration
Eight n8 astronauts on long duration missions will take part in this study This experiment uses the following hardwaresoftware HW SW A EasymotionSkin suit dry electrode muscle stimulation B non-invasive hand-held Myoton device digitized passive muscle stiffness data collection C a customized Myoton body template suit elastic yoga suit with customized anatomical reference labels to aid inflight Myoton data collection on dedicated perforated 2x2 cm small skin fields at 5 different skin measurement points MP neck back shoulder legs
Before and after flight the following tests will be done once Myoton data collection dynamometry strength test magnetic resonance imaging MRI for baseline comparison Researchers will compare data from a non EMS control group non EMS Astronauts retrospective to see if changes of passive muscle stiffness is seen in EMS Astronauts before during and after spaceflight
Detailed Description:
In a previous space analog study 60 days reactive jumps on a sledge during bed rest immobilisation Cologne Germany 2015 on n24 voluntary participants followed by an experiment on the International Space Station ISS MYOTONES 2015-2023 the investigators used non-invasive Myoton technology Myoton device to detect digital biomarkers passive muscle tone and stiffness on twelve n12 study participants together with clinical imaging MRI muscle strength tests dynamometry and blood samples biosamples to study muscle properties and adaptation in microgravity following routine inflight exercise in ISS Astronauts One of the MYOTONES ISS Astronaut already tested a space-qualified EasymotionSkin suit Demo-Tech Experiment German Aerospace Agency Deutsches Zentrum fuer Luft- und Raumfahrt DLR 2022 that was used for about 20 minutes on top of the daily routine exercise protocol in order to optimize inflight training outcome by EMS technology in spaceflight Preliminary results n1 showed feasibility of the novel EMS technology in spaceflight and suggested improved muscle health parameters increased tone and stiffness found in some muscle from torso lower back and limbs compared to a non-EMS mission crewmember Easymotion-2 is designed to replicate similar changes in inflight passive muscle parameters resembling muscle health in eight n8 more ISS Astronauts for robust statistical analyses and interpretation Pre and postflight baseline data collections with Myoton technology passive tone Hz and stiffness Nm serve as control for comparison Protocol and recruitment of healthy study participants male or female Astronauts is under control by NASA via Informed Consent Briefing standardized procedures
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None