Estimating the Optimal G Level for Training and Rehabilitation on a Short Arm Human Centrifuge
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Cardiovascular physiological parameter 1 cardiac output (CO) 2-lying
研究概览
简要总结
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).
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 17 Years 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •both male and female
- •height less than 2 m,
- •healthy or
- •with gait disorder or
- •impaired mobility from multiple sclerosis or
- •chronic obstructive pulmonary disease (COPD) or
排除标准
- •Neurological or psychiatric disorder,
- •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
- •newly inserted metal pins or plates, newly implanted stents .
研究组 & 干预措施
SHORT ARM HUMAN CENTRIFUGE
SHORT ARM HUMAN CENTRIFUGE IN COMBINATION WITH EXERCISE INTERMITTENT CENTRIFUGATION TOTAL TIME 30 MINUTES
干预措施: ARTIFICIAL GRAVITY COMBINED WITH EXERCISE (Device)
结局指标
主要结局
Cardiovascular physiological parameter 1 cardiac output (CO) 2-lying
时间窗: The time frame will include: changes from baseline up to 6 months
Cardiac output (CO) unit L/min, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes lying condition
Cardiovascular physiological parameter 2, Stroke volume (SV) 1-standing
时间窗: The time frame will include: changes from baseline up to 6 months
Stroke volume (SV) unit L/beat, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes standing position
Cardiovascular physiological parameter 3, mean arterial pressure (MAP) 1-standing
时间窗: The time frame will include: changes from baseline up to 6 months
Mean arterial pressure (MAP) unit mmHg, measured by a non invasive tensortip device attached to the subject's finger at standing position
Cardiovascular physiological parameter 3, mean arterial pressure (MAP) 2-lying
时间窗: The time frame will include: changes from baseline up to 6 months
Mean arterial pressure (MAP) unit mmHg, measured by a non invasive tensortip device attached to the subject's finger at lying position
Cardiovascular physiological parameter 3, mean arterial pressure (MAP) 4-medium intensity
时间窗: The time frame will include: changes from baseline up to 6 months
Mean arterial pressure (MAP) unit mmHg, measured by a non invasive tensortip device attached to the subject's finger after centrifugation with medium intensity (from 1,2g to1,5 g)
Cardiovascular physiological parameter 2, Stroke volume (SV) 3-mild intensity
时间窗: The time frame will include: changes from baseline up to 6 months
Stroke volume (SV) unit L/beat, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes centrifugation of mild intensity (from 0,5 g to 1 g
Cardiovascular physiological parameter 5, systolic blood pressure (SBP) 3-mild intensity
时间窗: The time frame will include: changes from baseline up to 6 months
Systolic blood pressure (SBP) unit mmHg, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes centrifugation with mild intensity (from 0,5 g to 1 g).
Cardiovascular physiological parameter 1 cardiac output (CO) 3-mild intensity
时间窗: The time frame will include: changes from baseline up to 6 months
Cardiac output (CO) unit L/min, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes mild intensity centrifugation condition
Cardiovascular physiological parameter 2, Stroke volume (SV) 2-lying
时间窗: The time frame will include: changes from baseline up to 6 months
Stroke volume (SV) unit L/beat, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes lying position
Cardiovascular physiological parameter 2, Stroke volume (SV) 5-high intensity
时间窗: The time frame will include: changes from baseline up to 6 months
Stroke volume (SV) unit L/beat, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes centrifugation of high intensity (from 1,7g to 2 g)
Cardiovascular physiological parameter 3, mean arterial pressure (MAP) 5-high intensity
时间窗: The time frame will include: changes from baseline up to 6 months
Mean arterial pressure (MAP) unit mmHg, measured by a non invasive tensortip device attached to the subject's finger after centrifugation with high intensity (from 1,7g to 2 g).
Cardiovascular physiological parameter 6, heart rate (HR) 1-standing
时间窗: The time frame will include: changes from baseline up to 6 months
Heart rate (HR) unit beats/min, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes at standing position
Cardiovascular physiological parameter 1 cardiac output (CO) 4-medium intensity
时间窗: The time frame will include: changes from baseline up to 6 months
Cardiac output (CO) unit L/min, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes medium intensity centrifugation condition
Cardiovascular physiological parameter 1 cardiac output (CO) 5-high intensity
时间窗: The time frame will include: changes from baseline up to 6 months
Cardiac output (CO) unit L/min, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes high intensity centrifugation condition
Cardiovascular physiological parameter 2, Stroke volume (SV) 4-medium intensity
时间窗: The time frame will include: changes from baseline up to 6 months
Stroke volume (SV) unit L/beat, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes centrifugation of medium intensity (from 1,2g to1,5 g
Cardiovascular physiological parameter 3, mean arterial pressure (MAP) 3-mild intensity
时间窗: The time frame will include: changes from baseline up to 6 months
Mean arterial pressure (MAP) unit mmHg, measured by a non invasive tensortip device attached to the subject's finger after centrifugation with mild intensity (from 0,5 g to 1 g)
Cardiovascular physiological parameter 4, diastolic blood pressure (DBP) 1-standing
时间窗: The time frame will include: changes from baseline up to 6 months
Diastolic blood pressure (DBP) unit mmHg,measured by a non invasive tensortip device attached to the subject's finger after 5 minutes standing position
Cardiovascular physiological parameter 4, diastolic blood pressure (DBP) 4-medium intensity
时间窗: 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).
Biological samples 5:ADENOSINE
时间窗: The time frame will include: changes in 3 months
Unit of measurement: µM from saliva
Cardiovascular physiological parameter 1 cardiac output (CO) 1-standing
时间窗: The time frame will include: changes from baseline up to 6 months
Cardiac output (CO) unit L/min, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes standing condition
Cardiovascular physiological parameter 4, diastolic blood pressure (DBP) 3-low intensity
时间窗: The time frame will include: changes from baseline up to 6 months
Diastolic blood pressure (DBP) unit mmHg,measured by a non invasive tensortip device attached to the subject's finger after centrifugation of mild intensity (from 0,5 g to 1 g).
Cardiovascular physiological parameter 4, diastolic blood pressure (DBP) 5-high intensity
时间窗: The time frame will include: changes from baseline up to 6 months
Diastolic blood pressure (DBP) unit mmHg,measured by a non invasive tensortip device attached to the subject's finger after centrifugation of high intensity (from 1,7g to 2 g).
Cardiovascular physiological parameter 5, systolic blood pressure (SBP) 2;lying
时间窗: The time frame will include: changes from baseline up to 6 months
Systolic blood pressure (SBP) unit mmHg, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes at lying position
Cardiovascular physiological parameter 5, systolic blood pressure (SBP) 4-medium intensity
时间窗: The time frame will include: changes from baseline up to 6 months
Systolic blood pressure (SBP) unit mmHg, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes centrifugation with medium intensity (from 1,2g to1,5 g)
Cardiovascular physiological parameter 6, heart rate (HR) 3-mild intensity
时间窗: The time frame will include: changes from baseline up to 6 months
Heart rate (HR) unit beats/min, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes centrifugation of mild intensity (from 0,5 g to 1 g).
Cardiovascular physiological parameter 6, heart rate (HR) 4-medium intensity
时间窗: The time frame will include: changes from baseline up to 6 months
Heart rate (HR) unit beats/min, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes centrifugation with medium intensity (from 1,2g to1,5 g).
Cardiovascular physiological parameter 5, systolic blood pressure (SBP) 1-standing
时间窗: The time frame will include: changes from baseline up to 6 months
Systolic blood pressure (SBP) unit mmHg, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes at standing position
Cardiovascular physiological parameter 4, diastolic blood pressure (DBP) 2-lying
时间窗: The time frame will include: changes from baseline up to 6 months
Diastolic blood pressure (DBP) unit mmHg,measured by a non invasive tensortip device attached to the subject's finger after 5 minutes lying position
Cardiovascular physiological parameter 5, systolic blood pressure (SBP) 5-high intensity
时间窗: 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)
Electrical activity of the brain in alpha band, Electroencephalography (EEG)(μV) 1
时间窗: The time frame will include: changes from baseline up to 6 months
Recording of the brain's spontaneous electrical activity using multiple electrodes placed on the scalp with a conductive gel or paste, usually after preparing the scalp area by light abrasion to reduce impedance due to dead skin cells. Electrode locations and names are specified by the International 10-20 system.Each electrode is connected to one input of a differential amplifier, which amplifies the voltage between the active electrode and the reference (typically 1,000-100,000 times, or 60-100 dB of voltage gain) and the amplified signal is digitized via an analog-to-digital converter, after being passed through an anti-aliasing filter. Analog-to-digital sampling typically occurs at 256-512 Hz in clinical scalp EEG; sampling rates of up to 20 kHz will be used . The recording involves the subject with eyes open.
Electrical activity of the brain in alpha band, Electroencephalography (EEG)(μV) 2
时间窗: The time frame will include: changes from baseline up to 6 months
Recording of the brain's spontaneous electrical activity using multiple electrodes placed on the scalp with a conductive gel or paste, usually after preparing the scalp area by light abrasion to reduce impedance due to dead skin cells. Electrode locations and names are specified by the International 10-20 system.Each electrode is connected to one input of a differential amplifier, which amplifies the voltage between the active electrode and the reference (typically 1,000-100,000 times, or 60-100 dB of voltage gain) and the amplified signal is digitized via an analog-to-digital converter, after being passed through an anti-aliasing filter. Analog-to-digital sampling typically occurs at 256-512 Hz in clinical scalp EEG; sampling rates of up to 20 kHz will be used . The recording involves the subject with eyes closed.
Electrical activity of the brain in alpha band, Electroencephalography (EEG)(μV) 7
时间窗: The time frame will include: changes from baseline up to 6 months
Recording of the brain's spontaneous electrical activity using multiple electrodes placed on the scalp with a conductive gel or paste, usually after preparing the scalp area by light abrasion to reduce impedance due to dead skin cells. Electrode locations and names are specified by the International 10-20 system.Each electrode is connected to one input of a differential amplifier, which amplifies the voltage between the active electrode and the reference (typically 1,000-100,000 times, or 60-100 dB of voltage gain) and the amplified signal is digitized via an analog-to-digital converter, after being passed through an anti-aliasing filter. Analog-to-digital sampling typically occurs at 256-512 Hz in clinical scalp EEG; sampling rates of up to 20 kHz will be used . The recording involves the subject in centrifugation of high intensity (from 1,7g to 2 g).
The Short Physical Performance Battery assessment score
时间窗: 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).
Biological samples 4:MELATONINE
时间窗: The time frame will include: changes in 3 months
Unit of measurement: pg/mL from saliva
Cardiovascular physiological parameter 6, heart rate (HR) 2-lying
时间窗: The time frame will include: changes from baseline up to 6 months
Heart rate (HR) unit beats/min, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes at lying position
Cardiovascular physiological parameter 6, heart rate (HR) 5-high intensity
时间窗: The time frame will include: changes from baseline up to 6 months
Heart rate (HR) unit beats/min, measured by a non invasive tensortip device attached to the subject's finger after 5 minutes centrifugation of high intensity (from 1,7g to 2 g).
Electrical activity of the brain in alpha band, Electroencephalography (EEG)(μV) 3
时间窗: The time frame will include: changes from baseline up to 6 months
Recording of the brain's spontaneous electrical activity using multiple electrodes placed on the scalp with a conductive gel or paste, usually after preparing the scalp area by light abrasion to reduce impedance due to dead skin cells. Electrode locations and names are specified by the International 10-20 system.Each electrode is connected to one input of a differential amplifier, which amplifies the voltage between the active electrode and the reference (typically 1,000-100,000 times, or 60-100 dB of voltage gain) and the amplified signal is digitized via an analog-to-digital converter, after being passed through an anti-aliasing filter. Analog-to-digital sampling typically occurs at 256-512 Hz in clinical scalp EEG; sampling rates of up to 20 kHz will be used . The recording involves the subject in standing position.
Electrical activity of the brain in alpha band, Electroencephalography (EEG)(μV) 4
时间窗: 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.
Biological samples 8:Total leucocyte number:
时间窗: The time frame will include: changes in 3 months
Unit of measurement: number of cells x 10\^3/μL from serum
Biological samples 10:D-creatinine
时间窗: The time frame will include: changes in 3 months
Unit of measurement: mmol/l from serum
Biological samples 13: cortisol (SC) mg/dL
时间窗: The time frame will include: changes in 3 months
Unit of measurement: mg/dL, from saliva
Biological samples 16: Transcortin (mg/liter)
时间窗: The time frame will include: changes in 3 months
Unit of measurement: mg/liter, from serum
Electrical activity of the brain in alpha band, Electroencephalography (EEG)(μV) 6
时间窗: 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).
The Functional Gait Assessment (FGA)
时间窗: changes in 3 months
questionnaire
Gastrocnemius muscle oxygenation
时间窗: The time frame will include: changes in 3 months
Oxygen saturation (SmO2 (%)) of the gastrocnemius medialis muscle measured with muscle oxygen monitor" (MOXY) placed in the gastrocnemius muscle of the dominant leg during centrifugation
Biological samples 2: ADIPONECTINE
时间窗: The time frame will include: changes in 3 months
Unit of measurement: μg/mL from serum
Biological samples 3:BDNF
时间窗: The time frame will include: changes in 3 months
Unit of measurement: ng/ml from serum
Electrical activity of the brain in alpha band, Electroencephalography (EEG)(μV) 5
时间窗: 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).
Biological samples 1: CATECHOLAMINES
时间窗: The time frame will include: changes in 3 months
Unit of measurement: μmol from urine and saliva samples will be collected
Biological samples 5:TNF-α
时间窗: The time frame will include: changes in 3 months
Unit of measurement: pg/mL from serum
Biological samples 6:IL-1β
时间窗: The time frame will include: changes in 3 months
Unit of measurement: pg/mL from serum
Biological samples 11:alpha-amylase
时间窗: The time frame will include: changes in 3 months
Unit of measurement: IU, from serum
Biological samples 17: Total antioxidant capacity (TAC)
时间窗: The time frame will include: changes in 3 months
Unit of measurement: mM Trolox equivalent/l , from saliva
Height
时间窗: Day 1only
Unit:meters
Biological samples 7:High-sensitivity C-reactive Protein (hs-CRP)
时间窗: The time frame will include: changes in 3 months
Unit of measurement: mg/L from serum
Biological samples 14: Glucose
时间窗: The time frame will include: changes in 3 months
Unit of measurement: mg/dL, from serum
Biological samples 15: ACTH
时间窗: The time frame will include: changes in 3 months
Unit of measurement: ng/liter, from plasma
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
时间窗: changes in 3 months
unit: Kg
Biological samples 9:sTNF-RII
时间窗: The time frame will include: changes in 3 months
Unit of measurement: pg/ml from serum
Biological samples 12:secretory immunoglobulin A (sIgA)
时间窗: The time frame will include: changes in 3 months
Unit of measurement: mg/dL, from serum
Body Mass Index
时间窗: changes in 3 months
Unit: kg/m\^2).
次要结局
未报告次要终点