Electromyostimulation (EMS) of Astronauts in Spaceflight (Easymotion-2)
- Conditions
- Exercise OvertrainingMuscle AtrophyMyotoniaStiffness; Spine
- Interventions
- Device: Electromyostimulation (EMS)Device: MyotonDiagnostic Test: Electromyography (EMG)Diagnostic Test: Magnetic Resonance Imaging (MRI)Diagnostic Test: Dynamometry
- Registration Number
- NCT06492057
- Lead Sponsor
- Charite University, Berlin, Germany
- 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 (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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 12
Astronauts with active Flight Medical
- Heart disease
- Liver disease
- Diabetes
- Thrombosis
- Extreme blood pressure
- Abdominal & inguinal hernias (bulges)
- Strong neurological diseases
- Pregnancy
- Cancer
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description EMS (electromyostimulation) participants Myoton Healthy Astronauts that perform EMS-assisted inflight exercise onboard the International Space Station EMS (electromyostimulation) participants Electromyography (EMG) Healthy Astronauts that perform EMS-assisted inflight exercise onboard the International Space Station EMS (electromyostimulation) participants Electromyostimulation (EMS) Healthy Astronauts that perform EMS-assisted inflight exercise onboard the International Space Station EMS (electromyostimulation) participants Magnetic Resonance Imaging (MRI) Healthy Astronauts that perform EMS-assisted inflight exercise onboard the International Space Station EMS (electromyostimulation) participants Dynamometry Healthy Astronauts that perform EMS-assisted inflight exercise onboard the International Space Station
- Primary Outcome Measures
Name Time Method 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
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.
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 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.
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
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
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
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
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 (inflight, post EMS-2) NLT R-12 days (time window) Passive muscle tone \[Hz\] numerical indices. Abbreviations: see Outcome1
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 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.
Myoton Tone (inflight, post EMS-1) NET R-18 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 (inflight, preEMS-1) FD20-30 days (time window) Passive muscle stiffness \[N/m\] numerical indices. 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 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.
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
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
Myoton stiffness (recovery, postflight). R+30+/-10 days (time window) Passive muscle stiffness \[N/m\] numerical indices. 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 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 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
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
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
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
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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Charité - Universitätsmedizin Berlin
🇩🇪Berlin-Mitte, Berlin, Germany