Euromedica-Arogi Rehabilitation Center
Thessaloniki, FW, 54210, Greece
NCT Number: NCT04369976
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).
This study is active but is not currently recruiting participants.
17 year–90 year
All sexes
Interventional
Not applicable
Thessaloniki, FW, 54210, Greece
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:
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
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
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
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
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
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
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
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
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
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)
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
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
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)
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)
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).
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
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
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).
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).
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).
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
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
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).
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)
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)
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
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
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).
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).
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).
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.
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.
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.
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.
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).
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).
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).
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).
Time frame: changes in 3 months
questionnaire
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
Time frame: The time frame will include: changes in 3 months
Unit of measurement: μmol from urine and saliva samples will be collected
Time frame: The time frame will include: changes in 3 months
Unit of measurement: μg/mL from serum
Time frame: The time frame will include: changes in 3 months
Unit of measurement: ng/ml from serum
Time frame: The time frame will include: changes in 3 months
Unit of measurement: pg/mL from saliva
Time frame: The time frame will include: changes in 3 months
Unit of measurement: µM from saliva
Time frame: The time frame will include: changes in 3 months
Unit of measurement: pg/mL from serum
Time frame: The time frame will include: changes in 3 months
Unit of measurement: pg/mL from serum
Time frame: The time frame will include: changes in 3 months
Unit of measurement: mg/L from serum
Time frame: The time frame will include: changes in 3 months
Unit of measurement: number of cells x 10^3/μL from serum
Time frame: The time frame will include: changes in 3 months
Unit of measurement: pg/ml from serum
Time frame: The time frame will include: changes in 3 months
Unit of measurement: mmol/l from serum
Time frame: The time frame will include: changes in 3 months
Unit of measurement: IU, from serum
Time frame: The time frame will include: changes in 3 months
Unit of measurement: mg/dL, from serum
Time frame: The time frame will include: changes in 3 months
Unit of measurement: mg/dL, from saliva
Time frame: The time frame will include: changes in 3 months
Unit of measurement: mg/dL, from serum
Time frame: The time frame will include: changes in 3 months
Unit of measurement: ng/liter, from plasma
Time frame: The time frame will include: changes in 3 months
Unit of measurement: mg/liter, from serum
Time frame: The time frame will include: changes in 3 months
Unit of measurement: mM Trolox equivalent/l , from saliva
Time frame: changes in 3 months
unit: Kg
Time frame: Day 1only
Unit:meters
Time frame: changes in 3 months
Unit: kg/m^2).
Greek Aerospace Medical Association and Space Research
Other
Estimating the Optimal G Level for Training and Rehabilitation on a Short Arm Human Centrifuge
Acronym: GRACER1
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