Clinical trial NCT06492057: Electromyostimulation (EMS) of Astronauts in Spaceflight (Easymotion-2)
Official title: ElectroMyoStimulation (EMS Body Suit) Protocol to Improve Exercise Outcome in Space Missions (EasyMotion-2)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Muscle Atrophy
Myotonia
Stiffness; Spine
Exercise Overtraining
Keywords: skeletal muscle
passive muscle stiffness
muscle health
electromyostimulation
space flight
countermeasure
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: German Sport University, Cologne
First posted: 2024-07-09
Enrollment: 12
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Myoton Tone (baseline preflight)
timeFrame: L-105+/-30 days (time window)
measure: Myoton Tone (recovery postflight)
timeFrame: R+30+/-10 days (time window)
measure: Myoton Tone (inflight, preEMS-1)
timeFrame: FD20-30 days (time window)
measure: Myoton Tone (inflight, preEMS-2)
timeFrame: FD60-80 days (time window)
measure: Myoton Tone (inflight, post EMS-1)
timeFrame: NET R-18 days (time window)
measure: Myoton Tone (inflight, post EMS-2)
timeFrame: NLT R-12 days (time window)
measure: Myoton stiffness (baseline, preflight).
timeFrame: L-105+/-30 days (time window)
measure: Myoton stiffness (recovery, postflight).
timeFrame: R+30+/-10 days (time window)
measure: Myoton stiffness (inflight, preEMS-1)
timeFrame: FD20-30 days (time window)
measure: Myoton stiffness (inflight, preEMS-2)
timeFrame: FD60-80 days (time window)
measure: Myoton stiffness (inflight, postEMS-1)
timeFrame: NET R-18 days (time window)
measure: Myoton stiffness (inflight, postEMS-2)
timeFrame: NLT R-12 days (time window)
measure: EMS body stimulation (inflight EMS1)
timeFrame: NET R-60 and NLT R-21 days (time window)
measure: EMS body stimulation (inflight EMS2)
timeFrame: NET R-60 and NLT R-21 days (time window)
measure: EMS body stimulation (inflight EMS3)
timeFrame: NET R-60 and NLT R-21 days(time window)
measure: EMS body stimulation (inflight EMS4)
timeFrame: NET R-60 and NLT R-21 days (time window)
measure: EMS body stimulation (inflight EMS5)
timeFrame: NET R-60 and NLT R-21 days (time window)
measure: EMS body stimulation (inflight EMS6)
timeFrame: NET R-60 and NLT R-21 days (time window)
measure: EMS body stimulation (inflight EMS7)
timeFrame: NET R-60 and NLT R-21 days (time window)
measure: EMS body stimulation (inflight EMS8)
timeFrame: NET R-60 and NLT R-21 days (time window)
measure: EMS body stimulation (inflight EMS9)
timeFrame: NET R-60 and NLT R-21 days (time window)
measure: EMS body stimulation (inflight EMS10)
timeFrame: NET R-60 and NLT R-21 days (time window)
measure: EMS body stimulation (inflight EMS11)
timeFrame: NET R-60 and NLT R-21 days (time window)
measure: EMS body stimulation (inflight EMS12)
timeFrame: NET R-60 and NLT R-21 days (time window)
measure: Dynamometry (baseline, preflight/power).
timeFrame: L-105+/-30 days (time window)
measure: Dynamometry (baseline, preflight/torque).
timeFrame: L-105+/-30 days (time window)
measure: sEMG (baseline, preflight/amplitude).
timeFrame: L-105+/-30 days (time window)
measure: sEMG (baseline, preflight/frequency).
timeFrame: L-105+/-30 days (time window)
measure: Dynamometry (recovery postflight/power).
timeFrame: R+30+/-10 days (time window)
measure: Dynamometry (recovery postflight/torque).
timeFrame: R+30+/-10 days (time window)
measure: sEMG (recovery postflight/amplitude).
timeFrame: R+30+/-10 days (time window)
measure: sEMG (recovery postflight/frequency).
timeFrame: R+30+/-10 days (time window)
measure: Magnetic Resonance Imaging (MRI) (baseline preflight).
timeFrame: L-105+/-30 days (time window)
measure: Magnetic Resonance Imaging (MRI) (recovery postflight).
timeFrame: R+30+/-10 days (time window)
measure: EMS protocol report (ms)
timeFrame: NET R-60 and NLT R-21 days (time window)
measure: EMS protocol report (minutes)
timeFrame: NET R-60 and NLT R-21 days (time window)
measure: EMS protocol report (Hz)
timeFrame: NET R-60 and NLT R-21 days (time window)
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin-Mitte
country: Germany
facility: Charité - Universitätsmedizin Berlin
state: Berlin
Study officials:
affiliation: Charite-Universitätsmedizin Berlin, Germany
name: Dieter Blottner, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.