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NCT Number: NCT06492057

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

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

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Key information

Conditions

Muscle Atrophy Atrophy Exercise Overtraining Fatigue Muscular Atrophy Myotonia Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Overtraining Syndrome Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms Stiffness; Spine

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charité - Universitätsmedizin Berlin

Mitte, State of Berlin, 10117, Germany

About this study

In a previous space analog study (60 days reactive jumps on a sledge during bed rest immobilisation, Cologne, Germany, 2015) on n=24 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 (n=12) 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 (n=1) 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 (n=8) more ISS Astronauts for robust statistical analyses and interpretation. Pre and postflight baseline data collections with Myoton technology (passive tone [Hz] and stiffness [N/m]) 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Astronauts with active Flight Medical

Exclusion criteria

  • Heart disease
  • Liver disease
  • Diabetes
  • Thrombosis
  • Extreme blood pressure
  • Abdominal & inguinal hernias (bulges)
  • Strong neurological diseases
  • Pregnancy
  • Cancer

Treatment and study plan

Electromyostimulation (EMS)

Device

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

Other names: EMS body muscle stimulation

Myoton

Device

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

Other names: passive muscle properties

Electromyography (EMG)

Diagnostic Test

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

Other names: surface EMG/nerve impulse rate [amplitude/frequency]

Magnetic Resonance Imaging (MRI)

Diagnostic Test

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

Other names: MRI, Magnetic Resonance Tomography

Dynamometry

Diagnostic Test

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

Other names: muscle functional test

Primary outcomes

  1. Myoton Tone (baseline preflight)

    Time frame: 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.

  2. Myoton Tone (recovery postflight)

    Time frame: 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.

  3. Myoton Tone (inflight, preEMS-1)

    Time frame: FD20-30 days (time window)

    Passive muscle tone [Hz] numerical indices. Abbreviations: see Outcome1

  4. Myoton Tone (inflight, preEMS-2)

    Time frame: FD60-80 days (time window)

    Passive muscle tone [Hz] numerical indices. Abbreviations: see Outcome1

  5. Myoton Tone (inflight, post EMS-1)

    Time frame: NET R-18 days (time window)

    Passive muscle tone [Hz] numerical indices. Abbreviations: see Outcome1

  6. Myoton Tone (inflight, post EMS-2)

    Time frame: NLT R-12 days (time window)

    Passive muscle tone [Hz] numerical indices. Abbreviations: see Outcome1

  7. Myoton stiffness (baseline, preflight).

    Time frame: L-105+/-30 days (time window)

    Passive muscle stiffness [N/m] numerical indices. Abbreviations: see Outcome 1

  8. Myoton stiffness (recovery, postflight).

    Time frame: R+30+/-10 days (time window)

    Passive muscle stiffness [N/m] numerical indices. Abbreviations: see Outcome 1

  9. Myoton stiffness (inflight, preEMS-1)

    Time frame: FD20-30 days (time window)

    Passive muscle stiffness [N/m] numerical indices. Abbreviations: see Outcome 1

  10. Myoton stiffness (inflight, preEMS-2)

    Time frame: FD60-80 days (time window)

    Passive muscle stiffness [N/m] numerical indices. Abbreviations: see Outcome 1

  11. Myoton stiffness (inflight, postEMS-1)

    Time frame: NET R-18 days (time window)

    Passive muscle stiffness [N/m] numerical indices. Abbreviations: see Outcome 1

  12. Myoton stiffness (inflight, postEMS-2)

    Time frame: NLT R-12 days (time window)

    Passive muscle stiffness [N/m] numerical indices. Abbreviations: see Outcome 1

  13. EMS body stimulation (inflight EMS1)

    Time frame: 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.

  14. EMS body stimulation (inflight EMS2)

    Time frame: 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.

  15. EMS body stimulation (inflight EMS3)

    Time frame: 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.

  16. EMS body stimulation (inflight EMS4)

    Time frame: 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.

  17. EMS body stimulation (inflight EMS5)

    Time frame: 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.

  18. EMS body stimulation (inflight EMS6)

    Time frame: 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.

  19. EMS body stimulation (inflight EMS7)

    Time frame: 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.

  20. EMS body stimulation (inflight EMS8)

    Time frame: 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.

  21. EMS body stimulation (inflight EMS9)

    Time frame: 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.

  22. EMS body stimulation (inflight EMS10)

    Time frame: 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.

  23. EMS body stimulation (inflight EMS11)

    Time frame: 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.

  24. EMS body stimulation (inflight EMS12)

    Time frame: 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.

  25. Dynamometry (baseline, preflight/power).

    Time frame: 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

  26. Dynamometry (baseline, preflight/torque).

    Time frame: 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

  27. sEMG (baseline, preflight/amplitude).

    Time frame: 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

  28. sEMG (baseline, preflight/frequency).

    Time frame: 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

  29. Dynamometry (recovery postflight/power).

    Time frame: 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

  30. Dynamometry (recovery postflight/torque).

    Time frame: 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

  31. sEMG (recovery postflight/amplitude).

    Time frame: 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

  32. sEMG (recovery postflight/frequency).

    Time frame: 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

  33. Magnetic Resonance Imaging (MRI) (baseline preflight).

    Time frame: 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

  34. Magnetic Resonance Imaging (MRI) (recovery postflight).

    Time frame: 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

  35. EMS protocol report (ms)

    Time frame: 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

  36. EMS protocol report (minutes)

    Time frame: 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

  37. EMS protocol report (Hz)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • German Sport University, Cologne

Registry information

Official study title

ElectroMyoStimulation (EMS Body Suit) Protocol to Improve Exercise Outcome in Space Missions (EasyMotion-2)

Acronym: Easymotion-2

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Jul 9, 2024
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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