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Short Arm Human Centrifuge Therapeutic Training and Rehabilitation (GRACER1) (GRACER1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04369976
Recruitment Status : Recruiting
First Posted : April 30, 2020
Last Update Posted : May 1, 2020
Sponsor:
Information provided by (Responsible Party):
Greek Aerospace Medical Association and Space Research

Brief 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 pulmonary disease (COPD) and elderly people with balance and gait disorders (risk of falls).

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Stroke Pulmonary Disease, Chronic Obstructive Aged Device: ARTIFICIAL GRAVITY COMBINED WITH EXERCISE Not Applicable

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:

  1. A set of cardiovascular biosignal sensors described above,
  2. Electroencephalographic (EEG) recordings,
  3. The functional gait assessment (FGA) and
  4. 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 105 participants
Intervention Model: Sequential Assignment
Intervention 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)
Primary Purpose: Prevention
Official Title: Estimating the Optimal G Level for Training and Rehabilitation on a Short Arm Human Centrifuge
Actual Study Start Date : February 1, 2020
Estimated Primary Completion Date : February 1, 2022
Estimated Study Completion Date : August 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: SHORT ARM HUMAN CENTRIFUGE
SHORT ARM HUMAN CENTRIFUGE IN COMBINATION WITH EXERCISE INTERMITTENT CENTRIFUGATION TOTAL TIME 30 MINUTES
Device: ARTIFICIAL GRAVITY COMBINED WITH EXERCISE
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 .
Other Name: standard of care (SOC) rehabilitation program




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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)

  11. 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

  12. 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

  13. 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)

  14. 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)

  15. 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).

  16. 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

  17. 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

  18. 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).

  19. 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).

  20. 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).

  21. 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

  22. 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

  23. 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).

  24. 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)

  25. 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)

  26. 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

  27. 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

  28. 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).

  29. 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).

  30. 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).

  31. 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.


  32. 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.


  33. 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.


  34. 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.


  35. 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).


  36. 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).


  37. 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).


  38. 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).


  39. The Functional Gait Assessment (FGA) [ Time Frame: changes in 3 months ]
    questionnaire

  40. 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

  41. 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

  42. Biological samples 2: ADIPONECTINE [ Time Frame: The time frame will include: changes in 3 months ]
    Unit of measurement: μg/mL from serum

  43. Biological samples 3:BDNF [ Time Frame: The time frame will include: changes in 3 months ]
    Unit of measurement: ng/ml from serum

  44. Biological samples 4:MELATONINE [ Time Frame: The time frame will include: changes in 3 months ]
    Unit of measurement: pg/mL from saliva

  45. Biological samples 5:ADENOSINE [ Time Frame: The time frame will include: changes in 3 months ]
    Unit of measurement: µM from saliva

  46. Biological samples 5:TNF-α [ Time Frame: The time frame will include: changes in 3 months ]
    Unit of measurement: pg/mL from serum

  47. Biological samples 6:IL-1β [ Time Frame: The time frame will include: changes in 3 months ]
    Unit of measurement: pg/mL from serum

  48. 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

  49. 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

  50. Biological samples 9:sTNF-RII [ Time Frame: The time frame will include: changes in 3 months ]
    Unit of measurement: pg/ml from serum

  51. Biological samples 10:D-creatinine [ Time Frame: The time frame will include: changes in 3 months ]
    Unit of measurement: mmol/l from serum

  52. Biological samples 11:alpha-amylase [ Time Frame: The time frame will include: changes in 3 months ]
    Unit of measurement: IU, from serum

  53. 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

  54. 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

  55. Biological samples 14: Glucose [ Time Frame: The time frame will include: changes in 3 months ]
    Unit of measurement: mg/dL, from serum

  56. Biological samples 15: ACTH [ Time Frame: The time frame will include: changes in 3 months ]
    Unit of measurement: ng/liter, from plasma

  57. Biological samples 16: Transcortin (mg/liter) [ Time Frame: The time frame will include: changes in 3 months ]
    Unit of measurement: mg/liter, from serum

  58. 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

  59. 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

  60. Height [ Time Frame: Day 1only ]
    Unit:meters

  61. Body Mass Index [ Time Frame: changes in 3 months ]
    Unit: kg/m^2).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   17 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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,
  • 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 .

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04369976


Contacts
Layout table for location contacts
Contact: CHRYSOULA KOURTIDOU-PAPADELI, MD, PHD 6977719714 ext 6977719714 papadc@auth.gr
Contact: PANAGIOTIS BAMIDIS, proffessor 6972008122 bamidis@med.auth.gr

Locations
Layout table for location information
Greece
Euromedica-Arogi Rehabilitation Center Recruiting
Thessaloniki, FW, Greece, 54210
Contact: CHRYSOULA KOURTIDOU-PAPADELI, MD, PHD    6977719714 ext 6977719714    papadc@auth.gr   
Contact: ELEFTHERIOS BAKAS, MD    6972896996    leftbakas@yahoo.gr   
Sponsors and Collaborators
Greek Aerospace Medical Association and Space Research
Investigators
Layout table for investigator information
Principal Investigator: CHRYSOULA KOURTIDOU-PAPADELI AeMC
Publications of Results:
Diaz 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.

Other Publications:
Frett, 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
Penaz 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.

Layout table for additonal information
Responsible Party: Greek Aerospace Medical Association and Space Research
ClinicalTrials.gov Identifier: NCT04369976    
Other Study ID Numbers: 001955
First Posted: April 30, 2020    Key Record Dates
Last Update Posted: May 1, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Pulmonary Disease, Chronic Obstructive
Multiple Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive