Electromyostimulation (EMS) of Astronauts in Spaceflight (Easymotion-2)

Condition(s) studied

Investigational drug(s) / intervention(s)

Electromyostimulation (EMS): EasymotionSkin body suit for digitally controlled electric impulses via Easymotion-2 software on crew iPad (frequency, impulse rate, duration) are transferred from integrated dry electrodes of the EMS- stimulation suit to activate surface muscle groups of the body (trunk), arms and legs

Myoton: The non-invasive Myoton technology collects data from passive muscle properties (tone and stiffness) obtained from selected anatomical surface muscle groups

Electromyography (EMG): As a standard method, surface EMG collects data from nerve impulse-triggered active muscle contractions, pre/postflight only

Magnetic Resonance Imaging (MRI): MRI is a clinically standard (non-radiation) imaging method to study structural changes of the human body (organs, muscle, bones, tendons) at the macroscopic level, pre/postflight only

Dynamometry: Dynamometry is a standard functional and diagnostic method to test muscle strength in sports and rehabilitation. pre/postflight only

Study 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

Eligibility

Primary outcome measure(s)

• Myoton Tone (baseline preflight) — L-105+/-30 days (time window)
  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.
• Myoton Tone (recovery postflight) — R+30+/-10 days (time window)
  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.
• Myoton Tone (inflight, preEMS-1) — FD20-30 days (time window)
  Passive muscle tone \[Hz\] numerical indices. Abbreviations: see Outcome1
• Myoton Tone (inflight, preEMS-2) — FD60-80 days (time window)
  Passive muscle tone \[Hz\] numerical indices. Abbreviations: see Outcome1
• Myoton Tone (inflight, post EMS-1) — NET R-18 days (time window)
  Passive muscle tone \[Hz\] numerical indices. Abbreviations: see Outcome1
• Myoton Tone (inflight, post EMS-2) — NLT R-12 days (time window)
  Passive muscle tone \[Hz\] numerical indices. Abbreviations: see Outcome1
• Myoton stiffness (baseline, preflight). — L-105+/-30 days (time window)
  Passive muscle stiffness \[N/m\] numerical indices. Abbreviations: see Outcome 1
• Myoton stiffness (recovery, postflight). — R+30+/-10 days (time window)
  Passive muscle stiffness \[N/m\] numerical indices. Abbreviations: see Outcome 1
• Myoton stiffness (inflight, preEMS-1) — FD20-30 days (time window)
  Passive muscle stiffness \[N/m\] numerical indices. Abbreviations: see Outcome 1
• Myoton stiffness (inflight, preEMS-2) — FD60-80 days (time window)
  Passive muscle stiffness \[N/m\] numerical indices. Abbreviations: see Outcome 1
• Myoton stiffness (inflight, postEMS-1) — NET R-18 days (time window)
  Passive muscle stiffness \[N/m\] numerical indices. Abbreviations: see Outcome 1
• Myoton stiffness (inflight, postEMS-2) — NLT R-12 days (time window)
  Passive muscle stiffness \[N/m\] numerical indices. Abbreviations: see Outcome 1
• EMS body stimulation (inflight EMS1) — NET R-60 and NLT R-21 days (time window)
  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.
• EMS body stimulation (inflight EMS2) — NET R-60 and NLT R-21 days (time window)
  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.
• EMS body stimulation (inflight EMS3) — NET R-60 and NLT R-21 days(time window)
  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.
• EMS body stimulation (inflight EMS4) — NET R-60 and NLT R-21 days (time window)
  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.
• EMS body stimulation (inflight EMS5) — NET R-60 and NLT R-21 days (time window)
  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.
• EMS body stimulation (inflight EMS6) — NET R-60 and NLT R-21 days (time window)
  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.
• EMS body stimulation (inflight EMS7) — NET R-60 and NLT R-21 days (time window)
  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.
• EMS body stimulation (inflight EMS8) — NET R-60 and NLT R-21 days (time window)
  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.
• EMS body stimulation (inflight EMS9) — NET R-60 and NLT R-21 days (time window)
  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.
• EMS body stimulation (inflight EMS10) — NET R-60 and NLT R-21 days (time window)
  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.
• EMS body stimulation (inflight EMS11) — NET R-60 and NLT R-21 days (time window)
  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.
• EMS body stimulation (inflight EMS12) — NET R-60 and NLT R-21 days (time window)
  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.
• Dynamometry (baseline, preflight/power). — L-105+/-30 days (time window)
  Standard muscle isometric/isokinetic tests (power \[Watt\] on calf muscle (gastrocnemius) and lower deep back muscle (erector spinae/multifidus). Abbreviations: see Outcome 1
• Dynamometry (baseline, preflight/torque). — L-105+/-30 days (time window)
  Standard muscle isometric/isokinetic tests ( torque \[Nm\]) on calf muscle (gastrocnemius) and lower deep back muscle (erector spinae/multifidus). Abbreviations: see Outcome 1
• sEMG (baseline, preflight/amplitude). — L-105+/-30 days (time window)
  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
• sEMG (baseline, preflight/frequency). — L-105+/-30 days (time window)
  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
• Dynamometry (recovery postflight/power). — R+30+/-10 days (time window)
  Standard muscle isometric/isokinetic tests (power \[Watt\] on calf muscle (gastrocnemius) and lower deep back muscle (erector spinae/multifidus). Abbreviations: see Outcome 1
• Dynamometry (recovery postflight/torque). — R+30+/-10 days (time window)
  Standard muscle isometric/isokinetic tests (torque \[Nm\] on calf muscle (gastrocnemius) and lower deep back muscle (erector spinae/multifidus). Abbreviations: see Outcome 1
• sEMG (recovery postflight/amplitude). — R+30+/-10 days (time window)
  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
• sEMG (recovery postflight/frequency). — R+30+/-10 days (time window)
  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
• Magnetic Resonance Imaging (MRI) (baseline preflight). — L-105+/-30 days (time window)
  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
• Magnetic Resonance Imaging (MRI) (recovery postflight). — R+30+/-10 days (time window)
  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
• EMS protocol report (ms) — NET R-60 and NLT R-21 days (time window)
  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
• EMS protocol report (minutes) — NET R-60 and NLT R-21 days (time window)
  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
• EMS protocol report (Hz) — NET R-60 and NLT R-21 days (time window)
  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

Trial sites (1)

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