Electromyostimulation (EMS) of Astronauts in Spaceflight (Easymotion-2)
NCT Number: NCT06492057
Acronym: Easymotion-2
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Muscle Atrophy|Myotonia|Stiffness; Spine|Exercise Overtraining
Interventions: DEVICE: Electromyostimulation (EMS)|DEVICE: Myoton|DIAGNOSTIC_TEST: Electromyography (EMG)|DIAGNOSTIC_TEST: Magnetic Resonance Imaging (MRI)|DIAGNOSTIC_TEST: Dynamometry
Sponsor: Charite University, Berlin, Germany
Collaborators: German Sport University, Cologne
Sex: ALL
Age: ADULT
Enrollment: 12
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-10-15
Completion Date: 2026-12-31
Locations: Charité - Universitätsmedizin Berlin, Berlin-Mitte, Berlin, 10117, Germany

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 (n=8) astronauts on long duration missions will take part in this study. This experiment uses the following hardware/software (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

Primary Outcome Measures: Myoton Tone (baseline preflight), Passive muscle tone \[Hz\] numerical indices. Abbreviations for Outcome Measures 1-37: Hertz, Hz; Newton/meter, N/m; before launch (preflight), L-; recovery (postflight), R+; inflight days, FD; not earlier than, NET; not later than, NLT; electro-myo-stimulation, EMS; versus/against, vs; surface electromyography, sEMG., L-105+/-30 days (time window)|Myoton Tone (recovery postflight), Passive muscle tone \[Hz\] numerical indices. Abbreviations for Outcome Measures 1-37: Hertz, Hz; Newton/meter, N/m; before launch (preflight), L-; recovery (postflight), R+; inflight days, FD; not earlier than, NET; not later than, NLT; electromyostimulation, EMS; versus/against, vs; surface electromyography, sEMG., R+30+/-10 days (time window)|Myoton Tone (inflight, preEMS-1), Passive muscle tone \[Hz\] numerical indices. Abbreviations: see Outcome1, FD20-30 days (time window)|Myoton Tone (inflight, preEMS-2), Passive muscle tone \[Hz\] numerical indices. Abbreviations: see Outcome1, FD60-80 days (time window)|Myoton Tone (inflight, post EMS-1), Passive muscle tone \[Hz\] numerical indices. Abbreviations: see Outcome1, NET R-18 days (time window)|Myoton Tone (inflight, post EMS-2), Passive muscle tone \[Hz\] numerical indices. Abbreviations: see Outcome1, NLT R-12 days (time window)|Myoton stiffness (baseline, preflight)., Passive muscle stiffness \[N/m\] numerical indices. Abbreviations: see Outcome 1, L-105+/-30 days (time window)|Myoton stiffness (recovery, postflight)., Passive muscle stiffness \[N/m\] numerical indices. Abbreviations: see Outcome 1, R+30+/-10 days (time window)|Myoton stiffness (inflight, preEMS-1), Passive muscle stiffness \[N/m\] numerical indices. Abbreviations: see Outcome 1, FD20-30 days (time window)|Myoton stiffness (inflight, preEMS-2), Passive muscle stiffness \[N/m\] numerical indices. Abbreviations: see Outcome 1, FD60-80 days (time window)|Myoton stiffness (inflight, postEMS-1), Passive muscle stiffness \[N/m\] numerical indices. Abbreviations: see Outcome 1, NET R-18 days (time window)|Myoton stiffness (inflight, postEMS-2), Passive muscle stiffness \[N/m\] numerical indices. Abbreviations: see Outcome 1, NLT R-12 days (time window)|EMS body stimulation (inflight EMS1), 1st out of a total of 12 (1/12) single EMS-assisted inflight exercise between NET R-60 and NLT R-21 days (time window) with 1-4 days in between "wash-out") at tolerable stimulation merged to nominal daily inflight exercise countermeasure sessions at crew discretion. Applies to Outcome Measures 13-24. Abbreviations: see Outcome 1., NET R-60 and NLT R-21 days (time window)|EMS body stimulation (inflight EMS2), 2/12 single EMS-assisted inflight exercise NET R-60 and NLT R-21 days (time window) with 1-4 days in between "wash-out") at tolerable stimulation merged to nominal daily inflight exercise countermeasure sessions at crew discretion. Applies to Outcome Measures 13-24: Abbreviations see Outcome 1., NET R-60 and NLT R-21 days (time window)|EMS body stimulation (inflight EMS3), 3/12 single EMS-assisted inflight exercise, NET R-60 and NLT R-21 days (time window) with 1-4 days in between "wash-out")at tolerable stimulation merged to nominal daily inflight exercise countermeasure sessions at crew discretion. Applies to Outcome Measures 13-24: Abbreviations see Outcome 1., NET R-60 and NLT R-21 days(time window)|EMS body stimulation (inflight EMS4), 4/12 single EMS-assisted inflight exercise NET R-60 and NLT R-21 days (time window) with 1-4 days in between "wash-out")at tolerable stimulation merged to nominal daily inflight exercise countermeasure sessions at crew discretion. Applies to Outcome Measures 13-24: Abbreviations see Outcome 1., NET R-60 and NLT R-21 days (time window)|EMS body stimulation (inflight EMS5), 5/12 single EMS-assisted inflight exercise NET R-60 and NLT R-21 days (time window) with 1-4 days in between "wash-out")at tolerable stimulation merged to nominal daily inflight exercise countermeasure sessions at crew discretion. Applies to Outcome Measures 13-24: Abbreviations see Outcome 1., NET R-60 and NLT R-21 days (time window)|EMS body stimulation (inflight EMS6), 6/12 single EMS-assisted inflight exercise NET R-60 and NLT R-21 days (time window) with 1-4 days in between "wash-out")at tolerable stimulation merged to nominal daily inflight exercise countermeasure sessions at crew discretion. Applies to Outcome Measures 13-24: Abbreviations see Outcome 1., NET R-60 and NLT R-21 days (time window)|EMS body stimulation (inflight EMS7), 7/12 single EMS-assisted inflight exercise, NET R-60 and NLT R-21 days (time window) with 1-4 days in between "wash-out")at tolerable stimulation merged to nominal daily inflight exercise countermeasure sessions at crew discretion. Applies to Outcome Measures 13-24: Abbreviations see Outcome 1., NET R-60 and NLT R-21 days (time window)|EMS body stimulation (inflight EMS8), 8/12 single EMS-assisted inflight exercise NET R-60 and NLT R-21 days (time window) with 1-4 days in between "wash-out") at tolerable stimulation merged to nominal daily inflight exercise countermeasure sessions at crew discretion. Applies to Outcome Measures 13-24: Abbreviations see Outcome 1., NET R-60 and NLT R-21 days (time window)|EMS body stimulation (inflight EMS9), 9/12 single EMS-assisted inflight exercise NET R-60 and NLT R-21 days (time window) with 1-4 days in between "wash-out") at tolerable stimulation merged to nominal daily inflight exercise countermeasure sessions at crew discretion. Applies to Outcome Measures 13-24: Abbreviations see Outcome 1., NET R-60 and NLT R-21 days (time window)|EMS body stimulation (inflight EMS10), 10/12 single EMS-assisted inflight exercise NET R-60 and NLT R-21 days (time window) with 1-4 days in between "wash-out") at tolerable stimulation merged to nominal daily inflight exercise countermeasure sessions at crew discretion. Applies to Outcome Measures 13-24: Abbreviations see Outcome 1., NET R-60 and NLT R-21 days (time window)|EMS body stimulation (inflight EMS11), 11/12 single EMS-assisted inflight exercise NET R-60 and NLT R-21 days (time window) with 1-4 days in between "wash-out") at tolerable stimulation merged to nominal daily inflight exercise countermeasure sessions at crew discretion. Applies to Outcome Measures 13-24: Abbreviations see Outcome 1., NET R-60 and NLT R-21 days (time window)|EMS body stimulation (inflight EMS12), Last out of a total of twelve (12/12) single EMS-assisted inflight exercise NET R-60 and NLT R-21 days (time window) with 1-4 days in between "wash-out") at tolerable stimulation merged to nominal daily inflight exercise countermeasure sessions at crew discretion. Applies to Outcome Measures 13-24: Abbreviations see Outcome 1., NET R-60 and NLT R-21 days (time window)|Dynamometry (baseline, preflight/power)., Standard muscle isometric/isokinetic tests (power \[Watt\] on calf muscle (gastrocnemius) and lower deep back muscle (erector spinae/multifidus). Abbreviations: see Outcome 1, L-105+/-30 days (time window)|Dynamometry (baseline, preflight/torque)., Standard muscle isometric/isokinetic tests ( torque \[Nm\]) on calf muscle (gastrocnemius) and lower deep back muscle (erector spinae/multifidus). Abbreviations: see Outcome 1, L-105+/-30 days (time window)|sEMG (baseline, preflight/amplitude)., Non-invasive sEMG by amplitude on calf muscle (gastrocnemius) and lower deep back muscle (erector spinae/multifidus) as part of dynamometry. Abbreviations: see Outcome 1, L-105+/-30 days (time window)|sEMG (baseline, preflight/frequency)., Non-invasive sEMG by frequency (Hz) on calf muscle (gastrocnemius) and lower deep back muscle (erector spinae/multifidus) as part of dynamometry. Abbreviations: see Outcome 1, L-105+/-30 days (time window)|Dynamometry (recovery postflight/power)., Standard muscle isometric/isokinetic tests (power \[Watt\] on calf muscle (gastrocnemius) and lower deep back muscle (erector spinae/multifidus). Abbreviations: see Outcome 1, R+30+/-10 days (time window)|Dynamometry (recovery postflight/torque)., Standard muscle isometric/isokinetic tests (torque \[Nm\] on calf muscle (gastrocnemius) and lower deep back muscle (erector spinae/multifidus). Abbreviations: see Outcome 1, R+30+/-10 days (time window)|sEMG (recovery postflight/amplitude)., Non-invasive surface EMG (amplitude) on calf muscle (gastrocnemius) and lower deep back muscle (erector spinae/multifidus) as part of dynamometry. Abbreviations: see Outcome 1, R+30+/-10 days (time window)|sEMG (recovery postflight/frequency)., Non-invasive surface EMG (Hz) on calf muscle (gastrocnemius) and lower deep back muscle (erector spinae/multifidus) as part of dynamometry. Abbreviations: see Outcome 1, R+30+/-10 days (time window)|Magnetic Resonance Imaging (MRI) (baseline preflight)., Standard clinical structural analysis by optical sections of lower leg and lumbar back muscle profile/volume area (square/3-D, centimeters). Abbreviations: see Outcome 1, L-105+/-30 days (time window)|Magnetic Resonance Imaging (MRI) (recovery postflight)., Standard clinical structural analysis by optical sections of lower leg and lumbar back muscle profile/volume area (square/3-D, centimeters). Abbreviations: see Outcome 1, R+30+/-10 days (time window)|EMS protocol report (ms), Multiple measurements (milliseconds=ms) will be aggregated for each of the 12 single inflight EMS session (see Outcome 13-24) to report on inflight EMS protocol and to collect technical data (of muscle stimulation) for whole body inflight EMS monitoring and assessment. see Outcome1, NET R-60 and NLT R-21 days (time window)|EMS protocol report (minutes), Multiple measurements (duration/min.) will be aggregated for each of the 12 single inflight EMS session (see Outcome 13-24) to report on inflight EMS protocol and to collect technical data (of muscle stimulation) for whole body inflight EMS monitoring and assessment. Abbreviations: see Outcome1, NET R-60 and NLT R-21 days (time window)|EMS protocol report (Hz), Multiple measurements (frequency/Hz) will be aggregated for each of the 12 single inflight EMS session (see Outcome 13-24) to report on inflight EMS protocol and to collect technical data (of muscle stimulation) for whole body inflight EMS monitoring and assessment. Abbreviations: see Outcome1, NET R-60 and NLT R-21 days (time window)