Estimating the Optimal G Level for Training and Rehabilitation on a Short Arm Human Centrifuge

Status unknownNot a drug-phase studyMS (type not specified)NCT04369976

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • ARTIFICIAL GRAVITY COMBINED WITH EXERCISE

What it measured

Main measures

  • Cardiovascular physiological parameter 1 cardiac output (CO) 1-standing

    The time frame will include: changes from baseline up to 6 months

  • Cardiovascular physiological parameter 1 cardiac output (CO) 2-lying

    The time frame will include: changes from baseline up to 6 months

  • Cardiovascular physiological parameter 1 cardiac output (CO) 3-mild intensity

    The time frame will include: changes from baseline up to 6 months

  • Cardiovascular physiological parameter 1 cardiac output (CO) 4-medium intensity

    The time frame will include: changes from baseline up to 6 months

  • Cardiovascular physiological parameter 1 cardiac output (CO) 5-high intensity

    The time frame will include: changes from baseline up to 6 months

  • Cardiovascular physiological parameter 2, Stroke volume (SV) 1-standing

    The time frame will include: changes from baseline up to 6 months

  • Cardiovascular physiological parameter 2, Stroke volume (SV) 2-lying

    The time frame will include: changes from baseline up to 6 months

  • Cardiovascular physiological parameter 2, Stroke volume (SV) 3-mild intensity

    The time frame will include: changes from baseline up to 6 months

  • Cardiovascular physiological parameter 2, Stroke volume (SV) 4-medium intensity

    The time frame will include: changes from baseline up to 6 months

  • Cardiovascular physiological parameter 2, Stroke volume (SV) 5-high intensity

    The time frame will include: changes from baseline up to 6 months

  • Cardiovascular physiological parameter 3, mean arterial pressure (MAP) 1-standing

    The time frame will include: changes from baseline up to 6 months

  • Cardiovascular physiological parameter 3, mean arterial pressure (MAP) 2-lying

    The time frame will include: changes from baseline up to 6 months

  • Cardiovascular physiological parameter 3, mean arterial pressure (MAP) 3-mild intensity

    The time frame will include: changes from baseline up to 6 months

  • Cardiovascular physiological parameter 3, mean arterial pressure (MAP) 4-medium intensity

    The time frame will include: changes from baseline up to 6 months

  • Cardiovascular physiological parameter 3, mean arterial pressure (MAP) 5-high intensity

    The time frame will include: changes from baseline up to 6 months

  • Cardiovascular physiological parameter 4, diastolic blood pressure (DBP) 1-standing

    The time frame will include: changes from baseline up to 6 months

  • Cardiovascular physiological parameter 4, diastolic blood pressure (DBP) 2-lying

    The time frame will include: changes from baseline up to 6 months

  • Cardiovascular physiological parameter 4, diastolic blood pressure (DBP) 3-low intensity

    The time frame will include: changes from baseline up to 6 months

  • Cardiovascular physiological parameter 4, diastolic blood pressure (DBP) 4-medium intensity

    The time frame will include: changes from baseline up to 6 months

  • Cardiovascular physiological parameter 4, diastolic blood pressure (DBP) 5-high intensity

    The time frame will include: changes from baseline up to 6 months

  • Cardiovascular physiological parameter 5, systolic blood pressure (SBP) 1-standing

    The time frame will include: changes from baseline up to 6 months

  • Cardiovascular physiological parameter 5, systolic blood pressure (SBP) 2;lying

    The time frame will include: changes from baseline up to 6 months

  • Cardiovascular physiological parameter 5, systolic blood pressure (SBP) 3-mild intensity

    The time frame will include: changes from baseline up to 6 months

  • Cardiovascular physiological parameter 5, systolic blood pressure (SBP) 4-medium intensity

    The time frame will include: changes from baseline up to 6 months

  • Cardiovascular physiological parameter 5, systolic blood pressure (SBP) 5-high intensity

    The time frame will include: changes from baseline up to 6 months

  • Cardiovascular physiological parameter 6, heart rate (HR) 1-standing

    The time frame will include: changes from baseline up to 6 months

  • Cardiovascular physiological parameter 6, heart rate (HR) 2-lying

    The time frame will include: changes from baseline up to 6 months

  • Cardiovascular physiological parameter 6, heart rate (HR) 3-mild intensity

    The time frame will include: changes from baseline up to 6 months

  • Cardiovascular physiological parameter 6, heart rate (HR) 4-medium intensity

    The time frame will include: changes from baseline up to 6 months

  • Cardiovascular physiological parameter 6, heart rate (HR) 5-high intensity

    The time frame will include: changes from baseline up to 6 months

  • Electrical activity of the brain in alpha band, Electroencephalography (EEG)(μV) 1

    The time frame will include: changes from baseline up to 6 months

    Nerve conduction tests
  • Electrical activity of the brain in alpha band, Electroencephalography (EEG)(μV) 2

    The time frame will include: changes from baseline up to 6 months

    Nerve conduction tests
  • Electrical activity of the brain in alpha band, Electroencephalography (EEG)(μV) 3

    The time frame will include: changes from baseline up to 6 months

    Nerve conduction tests
  • Electrical activity of the brain in alpha band, Electroencephalography (EEG)(μV) 4

    The time frame will include: changes from baseline up to 6 months

    Nerve conduction tests
  • Electrical activity of the brain in alpha band, Electroencephalography (EEG)(μV) 5

    The time frame will include: changes from baseline up to 6 months

    Nerve conduction tests
  • Electrical activity of the brain in alpha band, Electroencephalography (EEG)(μV) 6

    The time frame will include: changes from baseline up to 6 months

    Nerve conduction tests
  • Electrical activity of the brain in alpha band, Electroencephalography (EEG)(μV) 7

    The time frame will include: changes from baseline up to 6 months

    Nerve conduction tests
  • The Short Physical Performance Battery assessment score

    The time frame will include: changes from baseline up to 6 months

    Walking and mobilityPhysical function
  • The Functional Gait Assessment (FGA)

    changes in 3 months

    Walking and mobility
  • Gastrocnemius muscle oxygenation

    The time frame will include: changes in 3 months

  • Biological samples 1: CATECHOLAMINES

    The time frame will include: changes in 3 months

  • Biological samples 2: ADIPONECTINE

    The time frame will include: changes in 3 months

  • Biological samples 3:BDNF

    The time frame will include: changes in 3 months

  • Biological samples 4:MELATONINE

    The time frame will include: changes in 3 months

  • Biological samples 5:ADENOSINE

    The time frame will include: changes in 3 months

  • Biological samples 5:TNF-α

    The time frame will include: changes in 3 months

  • Biological samples 6:IL-1β

    The time frame will include: changes in 3 months

    Immune response
  • Biological samples 7:High-sensitivity C-reactive Protein (hs-CRP)

    The time frame will include: changes in 3 months

  • Biological samples 8:Total leucocyte number:

    The time frame will include: changes in 3 months

  • Biological samples 9:sTNF-RII

    The time frame will include: changes in 3 months

  • Biological samples 10:D-creatinine

    The time frame will include: changes in 3 months

  • Biological samples 11:alpha-amylase

    The time frame will include: changes in 3 months

  • Biological samples 12:secretory immunoglobulin A (sIgA)

    The time frame will include: changes in 3 months

  • Biological samples 13: cortisol (SC) mg/dL

    The time frame will include: changes in 3 months

  • Biological samples 14: Glucose

    The time frame will include: changes in 3 months

  • Biological samples 15: ACTH

    The time frame will include: changes in 3 months

  • Biological samples 16: Transcortin (mg/liter)

    The time frame will include: changes in 3 months

  • Biological samples 17: Total antioxidant capacity (TAC)

    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

    changes in 3 months

  • Height

    Day 1only

  • Body Mass Index

    changes in 3 months

Who could take part

MS (type not specified) · 17 to 90

Show the full criteria

Inclusion criteria

* both male and female * height less than 2 m, * healthy or * with gait disorder or * impaired mobility from multiple sclerosis or * stroke, * chronic obstructive pulmonary disease (COPD) or * elderly

Exclusion criteria

* Neurological or psychiatric disorder, * vertigo, * nausea or * chronic pain, * participants with a height greater than 2 meters, * participants with chronic use of substances or alcoholism, * with recent (within 6 months) surgery, * current arrhythmia, * severe migraines, * pregnancy, * epilepsy, * cholelithiasis or * kidney stones, * dehydration, * recent wounds from surgery, * recent fractures (unless recommended by a doctor), * acute inflammation or * pain and * newly inserted metal pins or plates, newly implanted stents .

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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).

Papers

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History

  1. Status changed from Running, not recruiting to Status unknown
  1. Started

    Feb 2020

  2. Main results due

    Mar 2021

  3. Finished

    Dec 2025

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