Multiple SclerosisGRACER1NCT04369976
Short Arm Human Centrifuge Therapeutic Training and Rehabilitation (GRACER1)
A study testing ARTIFICIAL GRAVITY COMBINED WITH EXERCISE in people with Multiple Sclerosis and Stroke, run by Greek Aerospace Medical Association and Space Research at 1 site in Greece.
Trial summary
The study is a single blind randomized controlled trial (RCT) designed to examine the benefit of a short arm human centrifuge intervention program (SAHC) combined with exercise, compared to a standard of care (SOC) rehabilitation program in physically impaired patients with MS, stroke, severe chronic obstructive… Read more about this study
- Who is it for?
- Ages 17 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Stroke, Pulmonary Disease, Chronic Obstructive
- What is being tested?
- ARTIFICIAL GRAVITY COMBINED WITH EXERCISE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteGreece
- Study dates
- 1 Feb 2020to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 90 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- both male and female
- height less than 2 m,
- healthy or
- with gait disorder or
- impaired mobility from multiple sclerosis or
- stroke,
- chronic obstructive pulmonary disease (COPD) or
- elderly
Who cannot join
- Neurological or psychiatric disorder,
- vertigo,
- nausea or
- chronic pain,
- participants with a height greater than 2 meters,
- participants with chronic use of substances or alcoholism,
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- with recent (within 6 months) surgery,
- current arrhythmia,
- severe migraines,
- pregnancy,
- epilepsy,
- cholelithiasis or
- kidney stones,
- dehydration,
- recent wounds from surgery,
- recent fractures (unless recommended by a doctor),
- acute inflammation or
- pain and
- newly inserted metal pins or plates, newly implanted stents .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Estimating the Optimal G Level for Training and Rehabilitation on a Short Arm Human Centrifuge
The study is a single blind randomized controlled trial (RCT) designed to examine the benefit of a short arm human centrifuge intervention program (SAHC) combined with exercise, compared to a standard of care (SOC) rehabilitation program in physically impaired patients with MS, stroke, severe chronic obstructive pulmonary disease (COPD) and elderly people with balance and gait disorders (risk of falls).
Read the detailed description
The patients will be randomly assigned to the short arm human centrifuge training (SAHC intervention), standard of care (SOC training) or a passive control. The SAHC intervention consists of 3 sessions per week. The session duration is 1 hour. The intervention will last 3 months.
Aiming to estimate the minimum number of participants required for obtaining reliable results, the investigators performed power analysis. It was conducted in g-power 3.1 to determine a sufficient sample size using an alpha of 0.05, a power of 0.80, and a medium effect size (f = 0.21). Based on the aforementioned assumptions, a total sample size of 26 participants per group was computed.
The passive control group will abstain from any exercise. Initially, there will be one session serving as an evaluation and familiarization of the SAHC group participants on the centrifuge. Its aim besides familiarization will be also to individually assess the optimal according to the participant's cardiovascular functioning with cardiac output (CO), stroke volume (SV) mean arterial pressure (MAP) diastolic blood pressure (DBP), systolic blood pressure (SBP), and heart rate (HR). These criteria are monitored at each training session and are used to dynamically adapt the intervention intensity. More specifically, after 6 training sessions (2 weeks), the centrifugation load will be increased and considering the cardiovascular criteria, centrifugation will be combined with either aerobic exercise (through an ergometer) or resistance training through elastic training bands. Further verification of the dynamic configuration of the intervention will be provided by the electroencephalographic (EEG) assessment. More specifically, resting state EEG (eyes open \& closed condition, lying in horizontal position) and centrifugation in three different intensities, mild (corresponding to 0.5,0.7, and 1 g), medium (corresponding to 1.2 and 1.5 g) and high intensity (corresponding to 1.7 and 2 g). Functional connectivity and cortical-network features derived from graph theory will be used by deep learning algorithms (convolutional neural networks) in order to define the optimal centrifuge training.
A set of core outcomes as described below will be collected at the following experimental time instances: a) baseline, b) after 4 weeks, c) 8 weeks, d) 3 months, e) 6-month follow-up, g) 12-month follow-up. The outcomes will be collected across the domains of body structure and function, activity, and participation as classified by the world health organization international classification of functioning (ICF), disability and health.
The primary outcomes are the following:
- A set of cardiovascular biosignal sensors described above,
- Electroencephalographic (EEG) recordings,
- The functional gait assessment (FGA) and
- The functioning differences assessed by changes in summary ordinal score on the short physical performance battery (SPPB). The battery consists of three tests: balance, gait ability and leg strength. The score for each test is given in categorical modality (0-4) based on run time intervals, and the total score will range from 0 (worst) to 12 points (best). The SPPB has been shown to be a valid instrument for screening frailty and predicting disability, institutionalization and mortality. A total score of less than 10 points indicates frailty and a high risk of disability and falls. 1 point change in the total score has demonstrated to be of clinical relevance.
More primary outcomes include other measures of gaze and postural stability, fatigue, and functional mobility, isokinetic strength and muscle oxygen consumption. Additionally, a set of biomarkers in blood and urine will be collected.
- Being tested
- ARTIFICIAL GRAVITY COMBINED WITH EXERCISE
- Medical subject headings
- Multiple Sclerosis, Stroke, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARTIFICIAL GRAVITY COMBINED WITH EXERCISEDevice
Also called standard of care (SOC) rehabilitation program
The passive control group will abstain from any exercise. Recordings of the participant's will include cardiovascular functioning cardiac output (CO), stroke volume (SV) mean arterial pressure (MAP) diastolic blood pressure (DBP), systolic blood pressure (SBP), and heart rate (HR), Electroencephalography ( EEG) as well as dynamic force and stance and muscle oxygenation. More specifically, after 6 training sessions (2 weeks), the centrifugation load will be increased and will be combined with either aerobic exercise (through an ergometer) or resistance training through elastic training bands. Functional connectivity and cortical-network features will be used by deep learning algorithms in order to define the optimal centrifuge training .
| Study group | Role | What they receive |
|---|---|---|
| SHORT ARM HUMAN CENTRIFUGE | Experimental | SHORT ARM HUMAN CENTRIFUGE IN COMBINATION WITH EXERCISE INTERMITTENT CENTRIFUGATION TOTAL TIME 30 MINUTES Receives: Device: ARTIFICIAL GRAVITY COMBINED WITH EXERCISE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular physiological parameter 1 cardiac output (CO) 1-standing
Cardiac output (CO) unit L/min, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes standing condition
Measured: The time frame will include: changes from baseline up to 6 months
Cardiovascular physiological parameter 1 cardiac output (CO) 2-lying
Cardiac output (CO) unit L/min, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes lying condition
Measured: The time frame will include: changes from baseline up to 6 months
Cardiovascular physiological parameter 1 cardiac output (CO) 3-mild intensity
Cardiac output (CO) unit L/min, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes mild intensity centrifugation condition
Measured: The time frame will include: changes from baseline up to 6 months
Cardiovascular physiological parameter 1 cardiac output (CO) 4-medium intensity
Cardiac output (CO) unit L/min, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes medium intensity centrifugation condition
Measured: The time frame will include: changes from baseline up to 6 months
Cardiovascular physiological parameter 1 cardiac output (CO) 5-high intensity
Cardiac output (CO) unit L/min, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes high intensity centrifugation condition
Measured: The time frame will include: changes from baseline up to 6 months
Cardiovascular physiological parameter 2, Stroke volume (SV) 1-standing
Stroke volume (SV) unit L/beat, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes standing position
Measured: The time frame will include: changes from baseline up to 6 months
Cardiovascular physiological parameter 2, Stroke volume (SV) 2-lying
Stroke volume (SV) unit L/beat, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes lying position
Measured: The time frame will include: changes from baseline up to 6 months
Cardiovascular physiological parameter 2, Stroke volume (SV) 3-mild intensity
Stroke volume (SV) unit L/beat, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes centrifugation of mild intensity (from 0,5 g to 1 g
Measured: The time frame will include: changes from baseline up to 6 months
Cardiovascular physiological parameter 2, Stroke volume (SV) 4-medium intensity
Stroke volume (SV) unit L/beat, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes centrifugation of medium intensity (from 1,2g to1,5 g
Measured: The time frame will include: changes from baseline up to 6 months
Cardiovascular physiological parameter 2, Stroke volume (SV) 5-high intensity
Stroke volume (SV) unit L/beat, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes centrifugation of high intensity (from 1,7g to 2 g)
Measured: The time frame will include: changes from baseline up to 6 months
Cardiovascular physiological parameter 3, mean arterial pressure (MAP) 1-standing
Mean arterial pressure (MAP) unit mmHg, measured by a non invasive tensortip device attached to the subject's finger at standing position
Measured: The time frame will include: changes from baseline up to 6 months
Cardiovascular physiological parameter 3, mean arterial pressure (MAP) 2-lying
Mean arterial pressure (MAP) unit mmHg, measured by a non invasive tensortip device attached to the subject's finger at lying position
Measured: The time frame will include: changes from baseline up to 6 months
Cardiovascular physiological parameter 3, mean arterial pressure (MAP) 3-mild intensity
Mean arterial pressure (MAP) unit mmHg, measured by a non invasive tensortip device attached to the subject's finger after centrifugation with mild intensity (from 0,5 g to 1 g)
Measured: The time frame will include: changes from baseline up to 6 months
Cardiovascular physiological parameter 3, mean arterial pressure (MAP) 4-medium intensity
Mean arterial pressure (MAP) unit mmHg, measured by a non invasive tensortip device attached to the subject's finger after centrifugation with medium intensity (from 1,2g to1,5 g)
Measured: The time frame will include: changes from baseline up to 6 months
Cardiovascular physiological parameter 3, mean arterial pressure (MAP) 5-high intensity
Mean arterial pressure (MAP) unit mmHg, measured by a non invasive tensortip device attached to the subject's finger after centrifugation with high intensity (from 1,7g to 2 g).
Measured: The time frame will include: changes from baseline up to 6 months
Cardiovascular physiological parameter 4, diastolic blood pressure (DBP) 1-standing
Diastolic blood pressure (DBP) unit mmHg,measured by a non invasive tensortip device attached to the subject's finger after 5 minutes standing position
Measured: The time frame will include: changes from baseline up to 6 months
Cardiovascular physiological parameter 4, diastolic blood pressure (DBP) 2-lying
Diastolic blood pressure (DBP) unit mmHg,measured by a non invasive tensortip device attached to the subject's finger after 5 minutes lying position
Measured: The time frame will include: changes from baseline up to 6 months
Cardiovascular physiological parameter 4, diastolic blood pressure (DBP) 3-low intensity
Diastolic blood pressure (DBP) unit mmHg,measured by a non invasive tensortip device attached to the subject's finger after centrifugation of mild intensity (from 0,5 g to 1 g).
Measured: The time frame will include: changes from baseline up to 6 months
Cardiovascular physiological parameter 4, diastolic blood pressure (DBP) 4-medium intensity
Diastolic blood pressure (DBP) unit mmHg,measured by a non invasive tensortip device attached to the subject's finger after centrifugation with medium intensity (from 1,2g to1,5 g).
Measured: The time frame will include: changes from baseline up to 6 months
Cardiovascular physiological parameter 4, diastolic blood pressure (DBP) 5-high intensity
Diastolic blood pressure (DBP) unit mmHg,measured by a non invasive tensortip device attached to the subject's finger after centrifugation of high intensity (from 1,7g to 2 g).
Measured: The time frame will include: changes from baseline up to 6 months
Cardiovascular physiological parameter 5, systolic blood pressure (SBP) 1-standing
Systolic blood pressure (SBP) unit mmHg, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes at standing position
Measured: The time frame will include: changes from baseline up to 6 months
Cardiovascular physiological parameter 5, systolic blood pressure (SBP) 2;lying
Systolic blood pressure (SBP) unit mmHg, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes at lying position
Measured: The time frame will include: changes from baseline up to 6 months
Cardiovascular physiological parameter 5, systolic blood pressure (SBP) 3-mild intensity
Systolic blood pressure (SBP) unit mmHg, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes centrifugation with mild intensity (from 0,5 g to 1 g).
Measured: The time frame will include: changes from baseline up to 6 months
Cardiovascular physiological parameter 5, systolic blood pressure (SBP) 4-medium intensity
Systolic blood pressure (SBP) unit mmHg, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes centrifugation with medium intensity (from 1,2g to1,5 g)
Measured: The time frame will include: changes from baseline up to 6 months
Cardiovascular physiological parameter 5, systolic blood pressure (SBP) 5-high intensity
Systolic blood pressure (SBP) unit mmHg, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes centrifugation with high intensity (from 1,7g to 2 g)
Measured: The time frame will include: changes from baseline up to 6 months
Cardiovascular physiological parameter 6, heart rate (HR) 1-standing
Heart rate (HR) unit beats/min, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes at standing position
Measured: The time frame will include: changes from baseline up to 6 months
Cardiovascular physiological parameter 6, heart rate (HR) 2-lying
Heart rate (HR) unit beats/min, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes at lying position
Measured: The time frame will include: changes from baseline up to 6 months
Cardiovascular physiological parameter 6, heart rate (HR) 3-mild intensity
Heart rate (HR) unit beats/min, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes centrifugation of mild intensity (from 0,5 g to 1 g).
Measured: The time frame will include: changes from baseline up to 6 months
Cardiovascular physiological parameter 6, heart rate (HR) 4-medium intensity
Heart rate (HR) unit beats/min, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes centrifugation with medium intensity (from 1,2g to1,5 g).
Measured: The time frame will include: changes from baseline up to 6 months
Cardiovascular physiological parameter 6, heart rate (HR) 5-high intensity
Heart rate (HR) unit beats/min, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes centrifugation of high intensity (from 1,7g to 2 g).
Measured: The time frame will include: changes from baseline up to 6 months
Electrical activity of the brain in alpha band, Electroencephalography (EEG)(μV) 1
Recording of the brain's spontaneous electrical activity using multiple electrodes placed on the scalp with a conductive gel or paste, usually after preparing the scalp area by light abrasion to reduce impedance due to dead skin cells. Electrode locations and names are specified by the International 10-20 system.Each electrode is connected to one input of a differential amplifier, which amplifies the voltage between the active electrode and the reference (typically 1,000-100,000 times, or 60-100 dB of voltage gain) and the amplified signal is digitized via an analog-to-digital converter, after being passed through an anti-aliasing filter. Analog-to-digital sampling typically occurs at 256-512 Hz in clinical scalp EEG; sampling rates of up to 20 kHz will be used .
The recording involves the subject with eyes open.
Measured: The time frame will include: changes from baseline up to 6 months
Electrical activity of the brain in alpha band, Electroencephalography (EEG)(μV) 2
Recording of the brain's spontaneous electrical activity using multiple electrodes placed on the scalp with a conductive gel or paste, usually after preparing the scalp area by light abrasion to reduce impedance due to dead skin cells. Electrode locations and names are specified by the International 10-20 system.Each electrode is connected to one input of a differential amplifier, which amplifies the voltage between the active electrode and the reference (typically 1,000-100,000 times, or 60-100 dB of voltage gain) and the amplified signal is digitized via an analog-to-digital converter, after being passed through an anti-aliasing filter. Analog-to-digital sampling typically occurs at 256-512 Hz in clinical scalp EEG; sampling rates of up to 20 kHz will be used .
The recording involves the subject with eyes closed.
Measured: The time frame will include: changes from baseline up to 6 months
Electrical activity of the brain in alpha band, Electroencephalography (EEG)(μV) 3
Recording of the brain's spontaneous electrical activity using multiple electrodes placed on the scalp with a conductive gel or paste, usually after preparing the scalp area by light abrasion to reduce impedance due to dead skin cells. Electrode locations and names are specified by the International 10-20 system.Each electrode is connected to one input of a differential amplifier, which amplifies the voltage between the active electrode and the reference (typically 1,000-100,000 times, or 60-100 dB of voltage gain) and the amplified signal is digitized via an analog-to-digital converter, after being passed through an anti-aliasing filter. Analog-to-digital sampling typically occurs at 256-512 Hz in clinical scalp EEG; sampling rates of up to 20 kHz will be used .
The recording involves the subject in standing position.
Measured: The time frame will include: changes from baseline up to 6 months
Electrical activity of the brain in alpha band, Electroencephalography (EEG)(μV) 4
Recording of the brain's spontaneous electrical activity using multiple electrodes placed on the scalp with a conductive gel or paste, usually after preparing the scalp area by light abrasion to reduce impedance due to dead skin cells. Electrode locations and names are specified by the International 10-20 system.Each electrode is connected to one input of a differential amplifier, which amplifies the voltage between the active electrode and the reference (typically 1,000-100,000 times, or 60-100 dB of voltage gain) and the amplified signal is digitized via an analog-to-digital converter, after being passed through an anti-aliasing filter. Analog-to-digital sampling typically occurs at 256-512 Hz in clinical scalp EEG; sampling rates of up to 20 kHz will be used .
The recording involves the subject in lying position.
Measured: The time frame will include: changes from baseline up to 6 months
Electrical activity of the brain in alpha band, Electroencephalography (EEG)(μV) 5
Recording of the brain's spontaneous electrical activity using multiple electrodes placed on the scalp with a conductive gel or paste, usually after preparing the scalp area by light abrasion to reduce impedance due to dead skin cells. Electrode locations and names are specified by the International 10-20 system.Each electrode is connected to one input of a differential amplifier, which amplifies the voltage between the active electrode and the reference (typically 1,000-100,000 times, or 60-100 dB of voltage gain) and the amplified signal is digitized via an analog-to-digital converter, after being passed through an anti-aliasing filter. Analog-to-digital sampling typically occurs at 256-512 Hz in clinical scalp EEG; sampling rates of up to 20 kHz will be used .
The recording involves the subject in centrifugation with mild intensity (from 0,5 g to 1 g).
Measured: The time frame will include: changes from baseline up to 6 months
Electrical activity of the brain in alpha band, Electroencephalography (EEG)(μV) 6
Recording of the brain's spontaneous electrical activity using multiple electrodes placed on the scalp with a conductive gel or paste, usually after preparing the scalp area by light abrasion to reduce impedance due to dead skin cells. Electrode locations and names are specified by the International 10-20 system.Each electrode is connected to one input of a differential amplifier, which amplifies the voltage between the active electrode and the reference (typically 1,000-100,000 times, or 60-100 dB of voltage gain) and the amplified signal is digitized via an analog-to-digital converter, after being passed through an anti-aliasing filter. Analog-to-digital sampling typically occurs at 256-512 Hz in clinical scalp EEG; sampling rates of up to 20 kHz will be used .
The recording involves the subject in centrifugation with medium intensity (from 1,2g to1,5 g).
Measured: The time frame will include: changes from baseline up to 6 months
Electrical activity of the brain in alpha band, Electroencephalography (EEG)(μV) 7
Recording of the brain's spontaneous electrical activity using multiple electrodes placed on the scalp with a conductive gel or paste, usually after preparing the scalp area by light abrasion to reduce impedance due to dead skin cells. Electrode locations and names are specified by the International 10-20 system.Each electrode is connected to one input of a differential amplifier, which amplifies the voltage between the active electrode and the reference (typically 1,000-100,000 times, or 60-100 dB of voltage gain) and the amplified signal is digitized via an analog-to-digital converter, after being passed through an anti-aliasing filter. Analog-to-digital sampling typically occurs at 256-512 Hz in clinical scalp EEG; sampling rates of up to 20 kHz will be used .
The recording involves the subject in centrifugation of high intensity (from 1,7g to 2 g).
Measured: The time frame will include: changes from baseline up to 6 months
The Short Physical Performance Battery assessment score
The functioning differences assessed by changes in summary ordinal score on Balance, gait ability and leg strength.
The score for each test is given in categorical modality (0-4) based on run time intervals, and the total score will range from 0 (worst) to 12 points (best).
Measured: The time frame will include: changes from baseline up to 6 months
The Functional Gait Assessment (FGA)
questionnaire
Measured: changes in 3 months
Gastrocnemius muscle oxygenation
Oxygen saturation (SmO2 (%)) of the gastrocnemius medialis muscle measured with muscle oxygen monitor" (MOXY) placed in the gastrocnemius muscle of the dominant leg during centrifugation
Measured: The time frame will include: changes in 3 months
Biological samples 1: CATECHOLAMINES
Unit of measurement: μmol from urine and saliva samples will be collected
Measured: The time frame will include: changes in 3 months
Biological samples 2: ADIPONECTINE
Unit of measurement: μg/mL from serum
Measured: The time frame will include: changes in 3 months
Biological samples 3:BDNF
Unit of measurement: ng/ml from serum
Measured: The time frame will include: changes in 3 months
Biological samples 4:MELATONINE
Unit of measurement: pg/mL from saliva
Measured: The time frame will include: changes in 3 months
Biological samples 5:ADENOSINE
Unit of measurement: µM from saliva
Measured: The time frame will include: changes in 3 months
Biological samples 5:TNF-α
Unit of measurement: pg/mL from serum
Measured: The time frame will include: changes in 3 months
Biological samples 6:IL-1β
Unit of measurement: pg/mL from serum
Measured: The time frame will include: changes in 3 months
Biological samples 7:High-sensitivity C-reactive Protein (hs-CRP)
Unit of measurement: mg/L from serum
Measured: The time frame will include: changes in 3 months
Biological samples 8:Total leucocyte number:
Unit of measurement: number of cells x 10^3/μL from serum
Measured: The time frame will include: changes in 3 months
Biological samples 9:sTNF-RII
Unit of measurement: pg/ml from serum
Measured: The time frame will include: changes in 3 months
Biological samples 10:D-creatinine
Unit of measurement: mmol/l from serum
Measured: The time frame will include: changes in 3 months
Biological samples 11:alpha-amylase
Unit of measurement: IU, from serum
Measured: The time frame will include: changes in 3 months
Biological samples 12:secretory immunoglobulin A (sIgA)
Unit of measurement: mg/dL, from serum
Measured: The time frame will include: changes in 3 months
Biological samples 13: cortisol (SC) mg/dL
Unit of measurement: mg/dL, from saliva
Measured: The time frame will include: changes in 3 months
Biological samples 14: Glucose
Unit of measurement: mg/dL, from serum
Measured: The time frame will include: changes in 3 months
Biological samples 15: ACTH
Unit of measurement: ng/liter, from plasma
Measured: The time frame will include: changes in 3 months
Biological samples 16: Transcortin (mg/liter)
Unit of measurement: mg/liter, from serum
Measured: The time frame will include: changes in 3 months
Biological samples 17: Total antioxidant capacity (TAC)
Unit of measurement: mM Trolox equivalent/l , from saliva
Measured: The time frame will include: changes in 3 months
weight in kilograms, height in meters), as appropriate, or to clarify how multiple measurements will be aggregated to arrive at one reported value (e.g., weight
unit: Kg
Measured: changes in 3 months
Height
Unit:meters
Measured: Day 1only
Body Mass Index
Unit: kg/m^2).
Measured: changes in 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2020
- Study start1 Feb 2020
- Primary completion1 Mar 2021
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- The use of a short arm human centrifuge intervention program (SAHC) combined with exercise, compared to a standard of care (SOC) rehabilitation program in physically impaired patients with MS, stroke, severe Chronic Obstructive Pulmonary Disease (COPD) and elderly people with balance and gait disorders (risk of falls). The patients will be randomly assigned to the centrifuge training (SAHC intervention), SOC training or a passive control group. The SAHC intervention consists of 3 sessions per week. The session duration is 1 hour. The intervention will last for 3 months.
- Masking
- None (open label)
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Greek Aerospace Medical Association and Space Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- CHRYSOULA KOURTIDOU-PAPADELI, Principal investigator, AeMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04369976
- Sponsor's protocol ID
- 001955
- Acronym
- GRACER1
- Status last verified
- Mar 2025
- First submitted
- 15 Apr 2020
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vernikos J. Human exploration of space: why, where, what for? Hippokratia. 2008 Aug;12 Suppl 1(Suppl 1):6-9.
PubMed 19048086Hargens AR, Bhattacharya R, Schneider SM. Space physiology VI: exercise, artificial gravity, and countermeasure development for prolonged space flight. Eur J Appl Physiol. 2013 Sep;113(9):2183-92. doi: 10.1007/s00421-012-2523-5. Epub 2012 Oct 19.
PubMed 23079865Vernikos J; New Collective Author. Artificial gravity intermittent centrifugation as a space flight countermeasure. J Gravit Physiol. 1997 Jul;4(2):P13-6.
PubMed 11540676Frett, T., Mayrhofer, M., Schwandtner, J. et al. An Innovative Short Arm Centrifuge for Future Studies on the Effects of Artificial Gravity on the Human Body. Microgravity Sci. Technol. 26, 249-255 (2014). https://doi.org/10.1007/s12217-014-9386-9 Received: 6 December 2013 / Accepted: 29 August 2014 / Published online: 19 September 2014 © Springer Science+Business Media Dordrecht 2014
Duda KR, Jarchow T, Young LR. Squat exercise biomechanics during short-radius centrifugation. Aviat Space Environ Med. 2012 Feb;83(2):102-10. doi: 10.3357/asem.2334.2012.
PubMed 22303588Clement GR, Bukley AP, Paloski WH. Artificial gravity as a countermeasure for mitigating physiological deconditioning during long-duration space missions. Front Syst Neurosci. 2015 Jun 17;9:92. doi: 10.3389/fnsys.2015.00092. eCollection 2015.
PubMed 26136665Martina JR, Westerhof BE, van Goudoever J, de Beaumont EM, Truijen J, Kim YS, Immink RV, Jobsis DA, Hollmann MW, Lahpor JR, de Mol BA, van Lieshout JJ. Noninvasive continuous arterial blood pressure monitoring with Nexfin(R). Anesthesiology. 2012 May;116(5):1092-103. doi: 10.1097/ALN.0b013e31824f94ed.
PubMed 22415387Penaz J. (1973). "Photoelectric measurement of blood pressure, volume and flow in the finger," in Proceedings of the Digest 10th Int Conf Med Biol Engng, (Dresden: International Federation for Medical and Biological Engineering; ), 104.
Stenger M. B., Evans J. M., Patwardhan A. R., Moore F. B., Hinghofer-Szalkay H., Rössler A., et al. (2007). Artificial gravity training improves orthostatic tolerance in ambulatory men and women. Acta Astronaut. 60 267-272. 10.3389/fphys.2018.00716
Trigg C. (2013). Design and Validation of a Compact Radius Centrifuge Artificial Gravity Test Platform. Ph.D. thesis, Massachusetts Institute of Technology, Cambridge.
Yang Y, Baker M, Graf S, Larson J, Caiozzo VJ. Hypergravity resistance exercise: the use of artificial gravity as potential countermeasure to microgravity. J Appl Physiol (1985). 2007 Nov;103(5):1879-87. doi: 10.1152/japplphysiol.00772.2007. Epub 2007 Sep 13.
PubMed 17872403Chriskos P, Frantzidis CA, Gkivogkli PT, Bamidis PD, Kourtidou-Papadeli C. Automatic Sleep Staging Employing Convolutional Neural Networks and Cortical Connectivity Images. IEEE Trans Neural Netw Learn Syst. 2020 Jan;31(1):113-123. doi: 10.1109/TNNLS.2019.2899781. Epub 2019 Mar 15.
PubMed 30892246LeBlanc A, Gogia P, Schneider V, Krebs J, Schonfeld E, Evans H. Calf muscle area and strength changes after five weeks of horizontal bed rest. Am J Sports Med. 1988 Nov-Dec;16(6):624-9. doi: 10.1177/036354658801600612.
PubMed 3239619Habazettl H, Stahn A, Nitsche A, Nordine M, Pries AR, Gunga HC, Opatz O. Microvascular responses to (hyper-)gravitational stress by short-arm human centrifuge: arteriolar vasoconstriction and venous pooling. Eur J Appl Physiol. 2016 Jan;116(1):57-65. doi: 10.1007/s00421-015-3241-6. Epub 2015 Aug 18.
PubMed 26280651Diaz Artiles, A., Heldt, T., and Young, L. R. (2016). Effects of artificial gravity on the cardio vascular system: computational approach. Acta Astronaut. 126, 395-410. doi: 10.1016/j.actaastro.2016.05.005.
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimating the Optimal G Level for Training and Rehabilitation on a Short Arm Human Centrifuge
- ClinicalTrials.gov ID
- NCT04369976
- Acronym / sponsor ID
- GRACER1 / 001955
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Greek Aerospace Medical Association and Space ResearchUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 30 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is a single blind randomized controlled trial (RCT) designed to examine the benefit of a short arm human centrifuge intervention program (SAHC) combined with exercise, compared to a standard of care (SOC) rehabilitation program in physically impaired patients with MS, stroke, severe chronic obstructive pulmonary disease (COPD) and elderly people with balance and gait disorders (risk of falls).
Detailed description
The patients will be randomly assigned to the short arm human centrifuge training (SAHC intervention), standard of care (SOC training) or a passive control. The SAHC intervention consists of 3 sessions per week. The session duration is 1 hour. The intervention will last 3 months.
Aiming to estimate the minimum number of participants required for obtaining reliable results, the investigators performed power analysis. It was conducted in g-power 3.1 to determine a sufficient sample size using an alpha of 0.05, a power of 0.80, and a medium effect size (f = 0.21). Based on the aforementioned assumptions, a total sample size of 26 participants per group was computed.
The passive control group will abstain from any exercise. Initially, there will be one session serving as an evaluation and familiarization of the SAHC group participants on the centrifuge. Its aim besides familiarization will be also to individually assess the optimal according to the participant's cardiovascular functioning with cardiac output (CO), stroke volume (SV) mean arterial pressure (MAP) diastolic blood pressure (DBP), systolic blood pressure (SBP), and heart rate (HR). These criteria are monitored at each training session and are used to dynamically adapt the intervention intensity. More specifically, after 6 training sessions (2 weeks), the centrifugation load will be increased and considering the cardiovascular criteria, centrifugation will be combined with either aerobic exercise (through an ergometer) or resistance training through elastic training bands. Further verification of the dynamic configuration of the intervention will be provided by the electroencephalographic (EEG) assessment. More specifically, resting state EEG (eyes open \& closed condition, lying in horizontal position) and centrifugation in three different intensities, mild (corresponding to 0.5,0.7, and 1 g), medium (corresponding to 1.2 and 1.5 g) and high intensity (corresponding to 1.7 and 2 g). Functional connectivity and cortical-network features derived from graph theory will be used by deep learning algorithms (convolutional neural networks) in order to define the optimal centrifuge training.
A set of core outcomes as described below will be collected at the following experimental time instances: a) baseline, b) after 4 weeks, c) 8 weeks, d) 3 months, e) 6-month follow-up, g) 12-month follow-up. The outcomes will be collected across the domains of body structure and function, activity, and participation as classified by the world health organization international classification of functioning (ICF), disability and health.
The primary outcomes are the following:
- A set of cardiovascular biosignal sensors described above,
- Electroencephalographic (EEG) recordings,
- The functional gait assessment (FGA) and
- The functioning differences assessed by changes in summary ordinal score on the short physical performance battery (SPPB). The battery consists of three tests: balance, gait ability and leg strength. The score for each test is given in categorical modality (0-4) based on run time intervals, and the total score will range from 0 (worst) to 12 points (best). The SPPB has been shown to be a valid instrument for screening frailty and predicting disability, institutionalization and mortality. A total score of less than 10 points indicates frailty and a high risk of disability and falls. 1 point change in the total score has demonstrated to be of clinical relevance.
More primary outcomes include other measures of gaze and postural stability, fatigue, and functional mobility, isokinetic strength and muscle oxygen consumption. Additionally, a set of biomarkers in blood and urine will be collected.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The use of a short arm human centrifuge intervention program (SAHC) combined with exercise, compared to a standard of care (SOC) rehabilitation program in physically impaired patients with MS, stroke, severe Chronic Obstructive Pulmonary Disease (COPD) and elderly people with balance and gait disorders (risk of falls). The patients will be randomly assigned to the centrifuge training (SAHC intervention), SOC training or a passive control group. The SAHC intervention consists of 3 sessions per week. The session duration is 1 hour. The intervention will last for 3 months.
| Arm | Type | Receives |
|---|---|---|
| SHORT ARM HUMAN CENTRIFUGE | Experimental | Device: ARTIFICIAL GRAVITY COMBINED WITH EXERCISESHORT ARM HUMAN CENTRIFUGE IN COMBINATION WITH EXERCISE INTERMITTENT CENTRIFUGATION TOTAL TIME 30 MINUTES |
Who may qualify
- Ages
- 17 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- both male and female
- height less than 2 m,
- healthy or
- with gait disorder or
- impaired mobility from multiple sclerosis or
Key exclusion criteria (19 listed)
- Neurological or psychiatric disorder,
- vertigo,
- nausea or
- chronic pain,
- participants with a height greater than 2 meters,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARTIFICIAL GRAVITY COMBINED WITH EXERCISEAlso: standard of care (SOC) rehabilitation programThe passive control group will abstain from any exercise. Recordings of the participant's will include cardiovascular functioning cardiac output (CO), stroke volume (SV) mean arterial pressure (MAP) diastolic blood pressure (DBP), systolic blood pressure (SBP), and heart rate (HR), Electroencephalography ( EEG) as well as dynamic force and stance and muscle oxygenation. More specifically, after 6 training sessions (2 weeks), the centrifugation load will be increased and will be combined with either aerobic exercise (through an ergometer) or resistance training through elastic training bands. Functional connectivity and cortical-network features will be used by deep learning algorithms in order to define the optimal centrifuge training . | Device | SHORT ARM HUMAN CENTRIFUGE |
Primary outcome
Cardiovascular physiological parameter 1 cardiac output (CO) 1-standing
Time frame: The time frame will include: changes from baseline up to 6 months
Cardiac output (CO) unit L/min, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes standing condition
Cardiovascular physiological parameter 1 cardiac output (CO) 2-lying
Time frame: The time frame will include: changes from baseline up to 6 months
Cardiac output (CO) unit L/min, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes lying condition
Cardiovascular physiological parameter 1 cardiac output (CO) 3-mild intensity
Time frame: The time frame will include: changes from baseline up to 6 months
Cardiac output (CO) unit L/min, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes mild intensity centrifugation condition
Cardiovascular physiological parameter 1 cardiac output (CO) 4-medium intensity
Time frame: The time frame will include: changes from baseline up to 6 months
Cardiac output (CO) unit L/min, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes medium intensity centrifugation condition
Cardiovascular physiological parameter 1 cardiac output (CO) 5-high intensity
Time frame: The time frame will include: changes from baseline up to 6 months
Cardiac output (CO) unit L/min, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes high intensity centrifugation condition
Cardiovascular physiological parameter 2, Stroke volume (SV) 1-standing
Time frame: The time frame will include: changes from baseline up to 6 months
Stroke volume (SV) unit L/beat, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes standing position
Cardiovascular physiological parameter 2, Stroke volume (SV) 2-lying
Time frame: The time frame will include: changes from baseline up to 6 months
Stroke volume (SV) unit L/beat, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes lying position
Cardiovascular physiological parameter 2, Stroke volume (SV) 3-mild intensity
Time frame: The time frame will include: changes from baseline up to 6 months
Stroke volume (SV) unit L/beat, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes centrifugation of mild intensity (from 0,5 g to 1 g
Cardiovascular physiological parameter 2, Stroke volume (SV) 4-medium intensity
Time frame: The time frame will include: changes from baseline up to 6 months
Stroke volume (SV) unit L/beat, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes centrifugation of medium intensity (from 1,2g to1,5 g
Cardiovascular physiological parameter 2, Stroke volume (SV) 5-high intensity
Time frame: The time frame will include: changes from baseline up to 6 months
Stroke volume (SV) unit L/beat, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes centrifugation of high intensity (from 1,7g to 2 g)
Cardiovascular physiological parameter 3, mean arterial pressure (MAP) 1-standing
Time frame: The time frame will include: changes from baseline up to 6 months
Mean arterial pressure (MAP) unit mmHg, measured by a non invasive tensortip device attached to the subject's finger at standing position
Cardiovascular physiological parameter 3, mean arterial pressure (MAP) 2-lying
Time frame: The time frame will include: changes from baseline up to 6 months
Mean arterial pressure (MAP) unit mmHg, measured by a non invasive tensortip device attached to the subject's finger at lying position
Cardiovascular physiological parameter 3, mean arterial pressure (MAP) 3-mild intensity
Time frame: The time frame will include: changes from baseline up to 6 months
Mean arterial pressure (MAP) unit mmHg, measured by a non invasive tensortip device attached to the subject's finger after centrifugation with mild intensity (from 0,5 g to 1 g)
Cardiovascular physiological parameter 3, mean arterial pressure (MAP) 4-medium intensity
Time frame: The time frame will include: changes from baseline up to 6 months
Mean arterial pressure (MAP) unit mmHg, measured by a non invasive tensortip device attached to the subject's finger after centrifugation with medium intensity (from 1,2g to1,5 g)
Cardiovascular physiological parameter 3, mean arterial pressure (MAP) 5-high intensity
Time frame: The time frame will include: changes from baseline up to 6 months
Mean arterial pressure (MAP) unit mmHg, measured by a non invasive tensortip device attached to the subject's finger after centrifugation with high intensity (from 1,7g to 2 g).
Cardiovascular physiological parameter 4, diastolic blood pressure (DBP) 1-standing
Time frame: The time frame will include: changes from baseline up to 6 months
Diastolic blood pressure (DBP) unit mmHg,measured by a non invasive tensortip device attached to the subject's finger after 5 minutes standing position
Cardiovascular physiological parameter 4, diastolic blood pressure (DBP) 2-lying
Time frame: The time frame will include: changes from baseline up to 6 months
Diastolic blood pressure (DBP) unit mmHg,measured by a non invasive tensortip device attached to the subject's finger after 5 minutes lying position
Cardiovascular physiological parameter 4, diastolic blood pressure (DBP) 3-low intensity
Time frame: The time frame will include: changes from baseline up to 6 months
Diastolic blood pressure (DBP) unit mmHg,measured by a non invasive tensortip device attached to the subject's finger after centrifugation of mild intensity (from 0,5 g to 1 g).
Cardiovascular physiological parameter 4, diastolic blood pressure (DBP) 4-medium intensity
Time frame: The time frame will include: changes from baseline up to 6 months
Diastolic blood pressure (DBP) unit mmHg,measured by a non invasive tensortip device attached to the subject's finger after centrifugation with medium intensity (from 1,2g to1,5 g).
Cardiovascular physiological parameter 4, diastolic blood pressure (DBP) 5-high intensity
Time frame: The time frame will include: changes from baseline up to 6 months
Diastolic blood pressure (DBP) unit mmHg,measured by a non invasive tensortip device attached to the subject's finger after centrifugation of high intensity (from 1,7g to 2 g).
Cardiovascular physiological parameter 5, systolic blood pressure (SBP) 1-standing
Time frame: The time frame will include: changes from baseline up to 6 months
Systolic blood pressure (SBP) unit mmHg, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes at standing position
Cardiovascular physiological parameter 5, systolic blood pressure (SBP) 2;lying
Time frame: The time frame will include: changes from baseline up to 6 months
Systolic blood pressure (SBP) unit mmHg, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes at lying position
Cardiovascular physiological parameter 5, systolic blood pressure (SBP) 3-mild intensity
Time frame: The time frame will include: changes from baseline up to 6 months
Systolic blood pressure (SBP) unit mmHg, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes centrifugation with mild intensity (from 0,5 g to 1 g).
Cardiovascular physiological parameter 5, systolic blood pressure (SBP) 4-medium intensity
Time frame: The time frame will include: changes from baseline up to 6 months
Systolic blood pressure (SBP) unit mmHg, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes centrifugation with medium intensity (from 1,2g to1,5 g)
Cardiovascular physiological parameter 5, systolic blood pressure (SBP) 5-high intensity
Time frame: The time frame will include: changes from baseline up to 6 months
Systolic blood pressure (SBP) unit mmHg, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes centrifugation with high intensity (from 1,7g to 2 g)
Cardiovascular physiological parameter 6, heart rate (HR) 1-standing
Time frame: The time frame will include: changes from baseline up to 6 months
Heart rate (HR) unit beats/min, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes at standing position
Cardiovascular physiological parameter 6, heart rate (HR) 2-lying
Time frame: The time frame will include: changes from baseline up to 6 months
Heart rate (HR) unit beats/min, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes at lying position
Cardiovascular physiological parameter 6, heart rate (HR) 3-mild intensity
Time frame: The time frame will include: changes from baseline up to 6 months
Heart rate (HR) unit beats/min, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes centrifugation of mild intensity (from 0,5 g to 1 g).
Cardiovascular physiological parameter 6, heart rate (HR) 4-medium intensity
Time frame: The time frame will include: changes from baseline up to 6 months
Heart rate (HR) unit beats/min, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes centrifugation with medium intensity (from 1,2g to1,5 g).
Cardiovascular physiological parameter 6, heart rate (HR) 5-high intensity
Time frame: The time frame will include: changes from baseline up to 6 months
Heart rate (HR) unit beats/min, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes centrifugation of high intensity (from 1,7g to 2 g).
Electrical activity of the brain in alpha band, Electroencephalography (EEG)(μV) 1
Time frame: The time frame will include: changes from baseline up to 6 months
Recording of the brain's spontaneous electrical activity using multiple electrodes placed on the scalp with a conductive gel or paste, usually after preparing the scalp area by light abrasion to reduce impedance due to dead skin cells. Electrode locations and names are specified by the International 10-20 system.Each electrode is connected to one input of a differential amplifier, which amplifies the voltage between the active electrode and the reference (typically 1,000-100,000 times, or 60-100 dB of voltage gain) and the amplified signal is digitized via an analog-to-digital converter, after being passed through an anti-aliasing filter. Analog-to-digital sampling typically occurs at 256-512 Hz in clinical scalp EEG; sampling rates of up to 20 kHz will be used . The recording involves the subject with eyes open.
Electrical activity of the brain in alpha band, Electroencephalography (EEG)(μV) 2
Time frame: The time frame will include: changes from baseline up to 6 months
Recording of the brain's spontaneous electrical activity using multiple electrodes placed on the scalp with a conductive gel or paste, usually after preparing the scalp area by light abrasion to reduce impedance due to dead skin cells. Electrode locations and names are specified by the International 10-20 system.Each electrode is connected to one input of a differential amplifier, which amplifies the voltage between the active electrode and the reference (typically 1,000-100,000 times, or 60-100 dB of voltage gain) and the amplified signal is digitized via an analog-to-digital converter, after being passed through an anti-aliasing filter. Analog-to-digital sampling typically occurs at 256-512 Hz in clinical scalp EEG; sampling rates of up to 20 kHz will be used . The recording involves the subject with eyes closed.
Electrical activity of the brain in alpha band, Electroencephalography (EEG)(μV) 3
Time frame: The time frame will include: changes from baseline up to 6 months
Recording of the brain's spontaneous electrical activity using multiple electrodes placed on the scalp with a conductive gel or paste, usually after preparing the scalp area by light abrasion to reduce impedance due to dead skin cells. Electrode locations and names are specified by the International 10-20 system.Each electrode is connected to one input of a differential amplifier, which amplifies the voltage between the active electrode and the reference (typically 1,000-100,000 times, or 60-100 dB of voltage gain) and the amplified signal is digitized via an analog-to-digital converter, after being passed through an anti-aliasing filter. Analog-to-digital sampling typically occurs at 256-512 Hz in clinical scalp EEG; sampling rates of up to 20 kHz will be used . The recording involves the subject in standing position.
Electrical activity of the brain in alpha band, Electroencephalography (EEG)(μV) 4
Time frame: The time frame will include: changes from baseline up to 6 months
Recording of the brain's spontaneous electrical activity using multiple electrodes placed on the scalp with a conductive gel or paste, usually after preparing the scalp area by light abrasion to reduce impedance due to dead skin cells. Electrode locations and names are specified by the International 10-20 system.Each electrode is connected to one input of a differential amplifier, which amplifies the voltage between the active electrode and the reference (typically 1,000-100,000 times, or 60-100 dB of voltage gain) and the amplified signal is digitized via an analog-to-digital converter, after being passed through an anti-aliasing filter. Analog-to-digital sampling typically occurs at 256-512 Hz in clinical scalp EEG; sampling rates of up to 20 kHz will be used . The recording involves the subject in lying position.
Electrical activity of the brain in alpha band, Electroencephalography (EEG)(μV) 5
Time frame: The time frame will include: changes from baseline up to 6 months
Recording of the brain's spontaneous electrical activity using multiple electrodes placed on the scalp with a conductive gel or paste, usually after preparing the scalp area by light abrasion to reduce impedance due to dead skin cells. Electrode locations and names are specified by the International 10-20 system.Each electrode is connected to one input of a differential amplifier, which amplifies the voltage between the active electrode and the reference (typically 1,000-100,000 times, or 60-100 dB of voltage gain) and the amplified signal is digitized via an analog-to-digital converter, after being passed through an anti-aliasing filter. Analog-to-digital sampling typically occurs at 256-512 Hz in clinical scalp EEG; sampling rates of up to 20 kHz will be used . The recording involves the subject in centrifugation with mild intensity (from 0,5 g to 1 g).
Electrical activity of the brain in alpha band, Electroencephalography (EEG)(μV) 6
Time frame: The time frame will include: changes from baseline up to 6 months
Recording of the brain's spontaneous electrical activity using multiple electrodes placed on the scalp with a conductive gel or paste, usually after preparing the scalp area by light abrasion to reduce impedance due to dead skin cells. Electrode locations and names are specified by the International 10-20 system.Each electrode is connected to one input of a differential amplifier, which amplifies the voltage between the active electrode and the reference (typically 1,000-100,000 times, or 60-100 dB of voltage gain) and the amplified signal is digitized via an analog-to-digital converter, after being passed through an anti-aliasing filter. Analog-to-digital sampling typically occurs at 256-512 Hz in clinical scalp EEG; sampling rates of up to 20 kHz will be used . The recording involves the subject in centrifugation with medium intensity (from 1,2g to1,5 g).
Electrical activity of the brain in alpha band, Electroencephalography (EEG)(μV) 7
Time frame: The time frame will include: changes from baseline up to 6 months
Recording of the brain's spontaneous electrical activity using multiple electrodes placed on the scalp with a conductive gel or paste, usually after preparing the scalp area by light abrasion to reduce impedance due to dead skin cells. Electrode locations and names are specified by the International 10-20 system.Each electrode is connected to one input of a differential amplifier, which amplifies the voltage between the active electrode and the reference (typically 1,000-100,000 times, or 60-100 dB of voltage gain) and the amplified signal is digitized via an analog-to-digital converter, after being passed through an anti-aliasing filter. Analog-to-digital sampling typically occurs at 256-512 Hz in clinical scalp EEG; sampling rates of up to 20 kHz will be used . The recording involves the subject in centrifugation of high intensity (from 1,7g to 2 g).
The Short Physical Performance Battery assessment score
Time frame: The time frame will include: changes from baseline up to 6 months
The functioning differences assessed by changes in summary ordinal score on Balance, gait ability and leg strength. The score for each test is given in categorical modality (0-4) based on run time intervals, and the total score will range from 0 (worst) to 12 points (best).
The Functional Gait Assessment (FGA)
Time frame: changes in 3 months
questionnaire
Gastrocnemius muscle oxygenation
Time frame: The time frame will include: changes in 3 months
Oxygen saturation (SmO2 (%)) of the gastrocnemius medialis muscle measured with muscle oxygen monitor" (MOXY) placed in the gastrocnemius muscle of the dominant leg during centrifugation
Biological samples 1: CATECHOLAMINES
Time frame: The time frame will include: changes in 3 months
Unit of measurement: μmol from urine and saliva samples will be collected
Biological samples 2: ADIPONECTINE
Time frame: The time frame will include: changes in 3 months
Unit of measurement: μg/mL from serum
Biological samples 3:BDNF
Time frame: The time frame will include: changes in 3 months
Unit of measurement: ng/ml from serum
Biological samples 4:MELATONINE
Time frame: The time frame will include: changes in 3 months
Unit of measurement: pg/mL from saliva
Biological samples 5:ADENOSINE
Time frame: The time frame will include: changes in 3 months
Unit of measurement: µM from saliva
Biological samples 5:TNF-α
Time frame: The time frame will include: changes in 3 months
Unit of measurement: pg/mL from serum
Biological samples 6:IL-1β
Time frame: The time frame will include: changes in 3 months
Unit of measurement: pg/mL from serum
Biological samples 7:High-sensitivity C-reactive Protein (hs-CRP)
Time frame: The time frame will include: changes in 3 months
Unit of measurement: mg/L from serum
Biological samples 8:Total leucocyte number:
Time frame: The time frame will include: changes in 3 months
Unit of measurement: number of cells x 10^3/μL from serum
Biological samples 9:sTNF-RII
Time frame: The time frame will include: changes in 3 months
Unit of measurement: pg/ml from serum
Biological samples 10:D-creatinine
Time frame: The time frame will include: changes in 3 months
Unit of measurement: mmol/l from serum
Biological samples 11:alpha-amylase
Time frame: The time frame will include: changes in 3 months
Unit of measurement: IU, from serum
Biological samples 12:secretory immunoglobulin A (sIgA)
Time frame: The time frame will include: changes in 3 months
Unit of measurement: mg/dL, from serum
Biological samples 13: cortisol (SC) mg/dL
Time frame: The time frame will include: changes in 3 months
Unit of measurement: mg/dL, from saliva
Biological samples 14: Glucose
Time frame: The time frame will include: changes in 3 months
Unit of measurement: mg/dL, from serum
Biological samples 15: ACTH
Time frame: The time frame will include: changes in 3 months
Unit of measurement: ng/liter, from plasma
Biological samples 16: Transcortin (mg/liter)
Time frame: The time frame will include: changes in 3 months
Unit of measurement: mg/liter, from serum
Biological samples 17: Total antioxidant capacity (TAC)
Time frame: The time frame will include: changes in 3 months
Unit of measurement: mM Trolox equivalent/l , from saliva
weight in kilograms, height in meters), as appropriate, or to clarify how multiple measurements will be aggregated to arrive at one reported value (e.g., weight
Time frame: changes in 3 months
unit: Kg
Height
Time frame: Day 1only
Unit:meters
Body Mass Index
Time frame: changes in 3 months
Unit: kg/m^2).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Background: PubMed 19048086Vernikos J. Human exploration of space: why, where, what for? Hippokratia. 2008 Aug;12 Suppl 1(Suppl 1):6-9.
- Background: PubMed 23079865Hargens AR, Bhattacharya R, Schneider SM. Space physiology VI: exercise, artificial gravity, and countermeasure development for prolonged space flight. Eur J Appl Physiol. 2013 Sep;113(9):2183-92. doi: 10.1007/s00421-012-2523-5. Epub 2012 Oct 19.
- Background: PubMed 11540676Vernikos J; New Collective Author. Artificial gravity intermittent centrifugation as a space flight countermeasure. J Gravit Physiol. 1997 Jul;4(2):P13-6.
- BackgroundFrett, T., Mayrhofer, M., Schwandtner, J. et al. An Innovative Short Arm Centrifuge for Future Studies on the Effects of Artificial Gravity on the Human Body. Microgravity Sci. Technol. 26, 249-255 (2014). https://doi.org/10.1007/s12217-014-9386-9 Received: 6 December 2013 / Accepted: 29 August 2014 / Published online: 19 September 2014 © Springer Science+Business Media Dordrecht 2014
- Background: PubMed 22303588Duda KR, Jarchow T, Young LR. Squat exercise biomechanics during short-radius centrifugation. Aviat Space Environ Med. 2012 Feb;83(2):102-10. doi: 10.3357/asem.2334.2012.
- Background: PubMed 26136665Clement GR, Bukley AP, Paloski WH. Artificial gravity as a countermeasure for mitigating physiological deconditioning during long-duration space missions. Front Syst Neurosci. 2015 Jun 17;9:92. doi: 10.3389/fnsys.2015.00092. eCollection 2015.
- Background: PubMed 22415387Martina JR, Westerhof BE, van Goudoever J, de Beaumont EM, Truijen J, Kim YS, Immink RV, Jobsis DA, Hollmann MW, Lahpor JR, de Mol BA, van Lieshout JJ. Noninvasive continuous arterial blood pressure monitoring with Nexfin(R). Anesthesiology. 2012 May;116(5):1092-103. doi: 10.1097/ALN.0b013e31824f94ed.
- BackgroundPenaz J. (1973). "Photoelectric measurement of blood pressure, volume and flow in the finger," in Proceedings of the Digest 10th Int Conf Med Biol Engng, (Dresden: International Federation for Medical and Biological Engineering; ), 104.
- BackgroundStenger M. B., Evans J. M., Patwardhan A. R., Moore F. B., Hinghofer-Szalkay H., Rössler A., et al. (2007). Artificial gravity training improves orthostatic tolerance in ambulatory men and women. Acta Astronaut. 60 267-272. 10.3389/fphys.2018.00716
- BackgroundTrigg C. (2013). Design and Validation of a Compact Radius Centrifuge Artificial Gravity Test Platform. Ph.D. thesis, Massachusetts Institute of Technology, Cambridge.
- Background: PubMed 17872403Yang Y, Baker M, Graf S, Larson J, Caiozzo VJ. Hypergravity resistance exercise: the use of artificial gravity as potential countermeasure to microgravity. J Appl Physiol (1985). 2007 Nov;103(5):1879-87. doi: 10.1152/japplphysiol.00772.2007. Epub 2007 Sep 13.
- Results publication: PubMed 30892246Chriskos P, Frantzidis CA, Gkivogkli PT, Bamidis PD, Kourtidou-Papadeli C. Automatic Sleep Staging Employing Convolutional Neural Networks and Cortical Connectivity Images. IEEE Trans Neural Netw Learn Syst. 2020 Jan;31(1):113-123. doi: 10.1109/TNNLS.2019.2899781. Epub 2019 Mar 15.
- Individual participant dataSharing planned: No
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Multiple Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
CHRYSOULA KOURTIDOU-PAPADELI principal investigator
AeMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ARTIFICIAL GRAVITY COMBINED WITH EXERCISE in people with Multiple Sclerosis and Stroke, run by Greek Aerospace Medical Association and Space Research at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular physiological parameter 1 cardiac output (CO) 1-standing (time frame: The time frame will include: changes from baseline up to 6 months). The study lists 61 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04369976, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.