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| Name | Class |
|---|---|
| German Sport University, Cologne | OTHER |
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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:
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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EMS (electromyostimulation) participants | Experimental | Healthy Astronauts that perform EMS-assisted inflight exercise onboard the International Space Station |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Astronauts with active Flight Medical
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dieter Blottner, PhD | Charite-Universitätsmedizin Berlin, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité - Universitätsmedizin Berlin | Mitte | State of Berlin | 10117 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38378866 | Background | Schoenrock B, Muckelt PE, Hastermann M, Albracht K, MacGregor R, Martin D, Gunga HC, Salanova M, Stokes MJ, Warner MB, Blottner D. Muscle stiffness indicating mission crew health in space. Sci Rep. 2024 Feb 20;14(1):4196. doi: 10.1038/s41598-024-54759-6. | |
| 35953503 | Background | Muckelt PE, Warner MB, Cheliotis-James T, Muckelt R, Hastermann M, Schoenrock B, Martin D, MacGregor R, Blottner D, Stokes M. Protocol and reference values for minimal detectable change of MyotonPRO and ultrasound imaging measurements of muscle and subcutaneous tissue. Sci Rep. 2022 Aug 11;12(1):13654. doi: 10.1038/s41598-022-17507-2. |
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Results will not be shared to other researchers due to privacy reasons of participating Astronauts related to their Space Agencies
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jan 24, 2024 | Jun 11, 2024 |
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In the second phase of their long-duration flight (>130 days or more), each participant wears a personalized Easymotionskin body suit (muscle stimulation suit) controlled by Easymotion App software on crew iPad for only for about 15-20 minutes while performing routine inflight exercise using standard inflight countermeasure devices (treadmill=T2, Cycle Ergometer on ISS, CEVIS; advanced Resistive Exercise Device, ARED) available onboard the ISS. Total EMS exercise time and duration: 12 times EMS plus T2, CEVIS or ARED within 3 weeks on ISS.
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Subject A to K
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| Myoton | Device | The non-invasive Myoton technology collects data from passive muscle properties (tone and stiffness) obtained from selected anatomical surface muscle groups |
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| Electromyography (EMG) | Diagnostic Test | As a standard method, surface EMG collects data from nerve impulse-triggered active muscle contractions, pre/postflight only |
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| 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 |
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| Dynamometry | Diagnostic Test | Dynamometry is a standard functional and diagnostic method to test muscle strength in sports and rehabilitation. pre/postflight only |
|
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| 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) |
| 30018567 | Background | Schoenrock B, Zander V, Dern S, Limper U, Mulder E, Veraksits A, Viir R, Kramer A, Stokes MJ, Salanova M, Peipsi A, Blottner D. Bed Rest, Exercise Countermeasure and Reconditioning Effects on the Human Resting Muscle Tone System. Front Physiol. 2018 Jul 3;9:810. doi: 10.3389/fphys.2018.00810. eCollection 2018. |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D009222 | Myotonia |
| D000095027 | Overtraining Syndrome |
| ID | Term |
|---|---|
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D005221 | Fatigue |
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| ID | Term |
|---|---|
| D004576 | Electromyography |
| D008279 | Magnetic Resonance Imaging |
| D000097873 | Postmortem Imaging |
| ID | Term |
|---|---|
| D004568 | Electrodiagnosis |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D009213 | Myography |
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D001344 | Autopsy |
| D008919 | Investigative Techniques |
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