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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Stroke; Multiple Sclerosis; Pulmonary Disease, Chronic Obstructive; Aged
• Intervention / Treatment: Device: ARTIFICIAL GRAVITY COMBINED WITH EXERCISE

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.

• Study Type: Interventional
• Enrollment (Estimated): 105
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: CHRYSOULA KOURTIDOU-PAPADELI, MD, PHD; Phone Number: 6977719714 6977719714; Email: papadc@auth.gr
• Study Contact Backup: Name: PANAGIOTIS BAMIDIS, proffessor; Phone Number: 6972008122; Email: bamidis@med.auth.gr

Study Locations

• Greece
  • FW
    • Thessaloniki, FW, Greece, 54210
      • Euromedica-Arogi Rehabilitation Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 90 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 .

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: standard of care (SOC) rehabilitation program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	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	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	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	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	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)	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	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	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)	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)	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).	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	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	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).	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).	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).	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	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	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).	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)	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)	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	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	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).	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).	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).	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.	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.	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.	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.	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).	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).	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).	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).	The time frame will include: changes from baseline up to 6 months
The Functional Gait Assessment (FGA)	questionnaire	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	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	The time frame will include: changes in 3 months
Biological samples 2: ADIPONECTINE	Unit of measurement: μg/mL from serum	The time frame will include: changes in 3 months
Biological samples 3:BDNF	Unit of measurement: ng/ml from serum	The time frame will include: changes in 3 months
Biological samples 4:MELATONINE	Unit of measurement: pg/mL from saliva	The time frame will include: changes in 3 months
Biological samples 5:ADENOSINE	Unit of measurement: µM from saliva	The time frame will include: changes in 3 months
Biological samples 5:TNF-α	Unit of measurement: pg/mL from serum	The time frame will include: changes in 3 months
Biological samples 6:IL-1β	Unit of measurement: pg/mL from serum	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	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	The time frame will include: changes in 3 months
Biological samples 9:sTNF-RII	Unit of measurement: pg/ml from serum	The time frame will include: changes in 3 months
Biological samples 10:D-creatinine	Unit of measurement: mmol/l from serum	The time frame will include: changes in 3 months
Biological samples 11:alpha-amylase	Unit of measurement: IU, from serum	The time frame will include: changes in 3 months
Biological samples 12:secretory immunoglobulin A (sIgA)	Unit of measurement: mg/dL, from serum	The time frame will include: changes in 3 months
Biological samples 13: cortisol (SC) mg/dL	Unit of measurement: mg/dL, from saliva	The time frame will include: changes in 3 months
Biological samples 14: Glucose	Unit of measurement: mg/dL, from serum	The time frame will include: changes in 3 months
Biological samples 15: ACTH	Unit of measurement: ng/liter, from plasma	The time frame will include: changes in 3 months
Biological samples 16: Transcortin (mg/liter)	Unit of measurement: mg/liter, from serum	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	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	changes in 3 months
Height	Unit:meters	Day 1only
Body Mass Index	Unit: kg/m^2).	changes in 3 months

Collaborators and Investigators

• Sponsor: Greek Aerospace Medical Association and Space Research
• Investigators: Principal Investigator: CHRYSOULA KOURTIDOU-PAPADELI, AeMC

Publications and helpful links

General Publications

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• Chriskos 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.
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• Habazettl 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.
• 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.
• Diaz-Artiles A, Heldt T, Young LR. Short-Term Cardiovascular Response to Short-Radius Centrifugation With and Without Ergometer Exercise. Front Physiol. 2018 Nov 13;9:1492. doi: 10.3389/fphys.2018.01492. eCollection 2018.
• Manen O, Dussault C, Sauvet F, Montmerle-Borgdorff S. Limitations of stroke volume estimation by non-invasive blood pressure monitoring in hypergravity. PLoS One. 2015 Mar 23;10(3):e0121936. doi: 10.1371/journal.pone.0121936. eCollection 2015.
• Truijen J, van Lieshout JJ, Wesselink WA, Westerhof BE. Noninvasive continuous hemodynamic monitoring. J Clin Monit Comput. 2012 Aug;26(4):267-78. doi: 10.1007/s10877-012-9375-8. Epub 2012 Jun 14.
• van der Spoel AG, Voogel AJ, Folkers A, Boer C, Bouwman RA. Comparison of noninvasive continuous arterial waveform analysis (Nexfin) with transthoracic Doppler echocardiography for monitoring of cardiac output. J Clin Anesth. 2012 Jun;24(4):304-9. doi: 10.1016/j.jclinane.2011.09.008.
• Verma AK, Xu D, Bruner M, Garg A, Goswami N, Blaber AP, Tavakolian K. Comparison of Autonomic Control of Blood Pressure During Standing and Artificial Gravity Induced via Short-Arm Human Centrifuge. Front Physiol. 2018 Jun 25;9:712. doi: 10.3389/fphys.2018.00712. eCollection 2018.
• Wang YC, Yang CB, Wu YH, Gao Y, Lu DY, Shi F, Wei XM, Sun XQ. Artificial gravity with ergometric exercise as a countermeasure against cardiovascular deconditioning during 4 days of head-down bed rest in humans. Eur J Appl Physiol. 2011 Sep;111(9):2315-25. doi: 10.1007/s00421-011-1866-7. Epub 2011 Feb 20.
• Yang CB, Zhang S, Zhang Y, Wang B, Yao YJ, Wang YC, Wu YH, Liang WB, Sun XQ. Combined short-arm centrifuge and aerobic exercise training improves cardiovascular function and physical working capacity in humans. Med Sci Monit. 2010 Dec;16(12):CR575-83.
• 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

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Actual): March 1, 2021
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: April 15, 2020
• First Submitted That Met QC Criteria: April 29, 2020
• First Posted (Actual): April 30, 2020

Study Record Updates

• Last Update Posted (Actual): February 22, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Lung Diseases; Disease Attributes; Lung Diseases, Obstructive; Chronic Disease; Multiple Sclerosis; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 001955

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No