Short Arm Human Centrifuge Therapeutic Training and Rehabilitation (GRACER1)

NCT04369976 | Active Not Recruiting

• 1 other identifier: 001955
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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).

Conditions

Multiple Sclerosis; Stroke; Pulmonary Disease, Chronic Obstructive; Aged

Outcome Measures

Primary Outcomes (61)

• 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

Study Arms (1)

SHORT ARM HUMAN CENTRIFUGE

EXPERIMENTAL

SHORT ARM HUMAN CENTRIFUGE IN COMBINATION WITH EXERCISE INTERMITTENT CENTRIFUGATION TOTAL TIME 30 MINUTES

Device: ARTIFICIAL GRAVITY COMBINED WITH EXERCISE

Interventions

ARTIFICIAL GRAVITY COMBINED WITH EXERCISE DEVICE

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 .

Also known as: standard of care (SOC) rehabilitation program

SHORT ARM HUMAN CENTRIFUGE

Eligibility Criteria

• Age: 17 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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,

Sponsors & Collaborators

• Greek Aerospace Medical Association and Space Research: lead

Study Sites (1)

Euromedica-Arogi Rehabilitation Center

Thessaloniki, FW, 54210, Greece

Location

Related Publications (23)

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MeSH Terms

Conditions

Multiple Sclerosis; Stroke; Pulmonary Disease, Chronic Obstructive

Interventions

Exercise Therapy; Rehabilitation

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• CHRYSOULA KOURTIDOU-PAPADELI

  AeMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 15, 2020
• First Posted: April 30, 2020
• Study Start: February 1, 2020
• Primary Completion: March 1, 2021
• Study Completion: December 1, 2025
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)