- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06492057
Electromyostimulation (EMS) of Astronauts in Spaceflight (Easymotion-2) (Easymotion-2)
ElectroMyoStimulation (EMS Body Suit) Protocol to Improve Exercise Outcome in Space Missions (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
Study Overview
Status
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
State of Berlin
-
Mitte, State of Berlin, Germany, 10117
- Charité - Universitätsmedizin Berlin
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: EMS (electromyostimulation) participants
Healthy Astronauts that perform EMS-assisted inflight exercise onboard the International Space Station
|
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:
The non-invasive Myoton technology collects data from passive muscle properties (tone and stiffness) obtained from selected anatomical surface muscle groups
Other Names:
As a standard method, surface EMG collects data from nerve impulse-triggered active muscle contractions, pre/postflight only
Other Names:
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:
Dynamometry is a standard functional and diagnostic method to test muscle strength in sports and rehabilitation.
pre/postflight only
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
L-105+/-30 days (time window)
|
|
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.
|
R+30+/-10 days (time window)
|
|
Myoton Tone (inflight, preEMS-1)
Time Frame: FD20-30 days (time window)
|
Passive muscle tone [Hz] numerical indices.
Abbreviations: see Outcome1
|
FD20-30 days (time window)
|
|
Myoton Tone (inflight, preEMS-2)
Time Frame: FD60-80 days (time window)
|
Passive muscle tone [Hz] numerical indices.
Abbreviations: see Outcome1
|
FD60-80 days (time window)
|
|
Myoton Tone (inflight, post EMS-1)
Time Frame: NET R-18 days (time window)
|
Passive muscle tone [Hz] numerical indices.
Abbreviations: see Outcome1
|
NET R-18 days (time window)
|
|
Myoton Tone (inflight, post EMS-2)
Time Frame: NLT R-12 days (time window)
|
Passive muscle tone [Hz] numerical indices.
Abbreviations: see Outcome1
|
NLT R-12 days (time window)
|
|
Myoton stiffness (baseline, preflight).
Time Frame: L-105+/-30 days (time window)
|
Passive muscle stiffness [N/m] numerical indices.
Abbreviations: see Outcome 1
|
L-105+/-30 days (time window)
|
|
Myoton stiffness (recovery, postflight).
Time Frame: R+30+/-10 days (time window)
|
Passive muscle stiffness [N/m] numerical indices.
Abbreviations: see Outcome 1
|
R+30+/-10 days (time window)
|
|
Myoton stiffness (inflight, preEMS-1)
Time Frame: FD20-30 days (time window)
|
Passive muscle stiffness [N/m] numerical indices.
Abbreviations: see Outcome 1
|
FD20-30 days (time window)
|
|
Myoton stiffness (inflight, preEMS-2)
Time Frame: FD60-80 days (time window)
|
Passive muscle stiffness [N/m] numerical indices.
Abbreviations: see Outcome 1
|
FD60-80 days (time window)
|
|
Myoton stiffness (inflight, postEMS-1)
Time Frame: NET R-18 days (time window)
|
Passive muscle stiffness [N/m] numerical indices.
Abbreviations: see Outcome 1
|
NET R-18 days (time window)
|
|
Myoton stiffness (inflight, postEMS-2)
Time Frame: NLT R-12 days (time window)
|
Passive muscle stiffness [N/m] numerical indices.
Abbreviations: see Outcome 1
|
NLT R-12 days (time window)
|
|
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.
|
NET R-60 and NLT R-21 days (time window)
|
|
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.
|
NET R-60 and NLT R-21 days (time window)
|
|
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.
|
NET R-60 and NLT R-21 days(time window)
|
|
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.
|
NET R-60 and NLT R-21 days (time window)
|
|
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.
|
NET R-60 and NLT R-21 days (time window)
|
|
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.
|
NET R-60 and NLT R-21 days (time window)
|
|
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.
|
NET R-60 and NLT R-21 days (time window)
|
|
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.
|
NET R-60 and NLT R-21 days (time window)
|
|
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.
|
NET R-60 and NLT R-21 days (time window)
|
|
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.
|
NET R-60 and NLT R-21 days (time window)
|
|
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.
|
NET R-60 and NLT R-21 days (time window)
|
|
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.
|
NET R-60 and NLT R-21 days (time window)
|
|
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
|
L-105+/-30 days (time window)
|
|
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
|
L-105+/-30 days (time window)
|
|
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
|
L-105+/-30 days (time window)
|
|
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
|
L-105+/-30 days (time window)
|
|
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
|
R+30+/-10 days (time window)
|
|
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
|
R+30+/-10 days (time window)
|
|
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
|
R+30+/-10 days (time window)
|
|
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
|
R+30+/-10 days (time window)
|
|
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
|
L-105+/-30 days (time window)
|
|
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
|
R+30+/-10 days (time window)
|
|
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
|
NET R-60 and NLT R-21 days (time window)
|
|
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
|
NET R-60 and NLT R-21 days (time window)
|
|
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
|
NET R-60 and NLT R-21 days (time window)
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Dieter Blottner, PhD, Charite-Universitätsmedizin Berlin, Germany
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Neuromuscular Manifestations
- Pathological Conditions, Anatomical
- Atrophy
- Fatigue
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Myotonia
- Muscular Atrophy
- Overtraining Syndrome
- Investigative Techniques
- Diagnostic Techniques and Procedures
- Diagnosis
- Tomography
- Diagnostic Imaging
- Electrodiagnosis
- Myography
- Autopsy
- Magnetic Resonance Imaging
- Electromyography
- Postmortem Imaging
Other Study ID Numbers
- 50WB2329
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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