Nervous System Diseases
Conditions
Interventions
Evaluation without physical training
Training and melatonin supplementation
Training and synbiotic supplementation
Training and placebo supplemntation
Sponsors
The Research Unit of the assessment of musculoskeletal disorders
Research Laboratory Molecular bases of human pathology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: *Patients under 60 years old *Sedentary. *No diet *EDSS : from 0 to 5 *Body mass index (BMI) <30 (kg/m²)
Exclusion criteria
Exclusion criteria: * 3 months before the study: Taking another supplement, antioxidant substances, vitamins or anti-inflammatory drugs. * No hormonal treatments or sleeping pills (hypnotics and anxiolytics) two weeks before the study * Patients who have undergone a rehabilitation protocol in the previous 6 months *A contraindication or an allergy to melatonin or probiotics * Smoking, alcoholism, drugs * Other chronic or autoimmune neurodegenerative comorbidities. * Diabetes, osteoporosis, other neurological, vestibular, cognitive, orthopedic, visual and psychiatric disorders. *Any contraindication to the practice of a physical activity (serious cardiovascular or pulmonary diseases, an exacerbation of the MS in the 4 weeks preceding the tests) *EDSS> or = 6 (Dependent patients or use assistive devices) * Pregnant or lactating women in the last six months, *Patients with nephrolithiasis in the last 5 years (related to synbiotic) * Women with irregular menstruation and unwilling to use appropriate contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1- Change in Psychological parameters will be measured using hospital anxiety depression scale (HADS). 2- change in cognitive function will be assessed using Simple reaction time (TRS), Trail Making test (TMT), Brief visual memory test (BVMT), Symbol Digit Modalities Test (SDMT), Rey–Osterrieth complex figure and Montreal cognitive assessment (MOCA), 3-change in Sexual Function will be evaluated by Questionnaire on Intimacy and Sexuality Related to Multiple Sclerosis .4- Change in fatigue: Fatigue severity scale (FSS), 5- change in sleep quality: Sleep Diary, Spiegel Sleep Questionnaire and Actigraphy. 6- Change in Quality of life : The Multiple Sclerosis International Quality of Life questionnaire (MusiQoL). 7- Change in Nociceptive pain will be investigated using analog visual scale (EVA), for change in Neuropathic pain we will use the DN4 questionnaire which contains 7 items for the interrogation of the patient and 3 items for clinical examination. 8-Change in muscle damage :Creatine phosphokinase (CPK),Transaminase aspartate aminotransferases (ASAT) and Alanine aminotransferase (ALAT) and Lactate dehydrogenase (LDH) and Gamma-glutamyltranspeptidase (Gamma GT), 8-change in oxidative stress: Malondialdehyde (MDA), Advanced Oxidation Protein Products (AOPP), reduced glutathione (GSH), bilirubin, uric acid, carbonylated proteins, catalase, superoxyde dismutase (SOD) and glutathione reductase (GR) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1-Neuroimaging will be performed using Magnetic resonance imaging (MRI) of the brain and spinal cord. 2- Cardio-respiratory capacity using an incremental cardiopulmonary test, 3-pulmonary function: spirometry, -Physiological response: change in central and peripheral fatigue will be measured using electromyography (EMG), change in Cardiac variability, resting heart rate variability (Polar), systolic blood pressure and diastolic blood pressure using blood pressure monitor.4- Change in Physical parameters :Isokinetic knee strength was measured with an isokinetic dynamometer (Cybex), fall risk: the four square step test, walking analysis using a Bessou locometer, manual dexterity using the nine hole peg test, Static and dynamic postural stability test will be performed in both conditions “eyes open” and “eyes closed” using the SATEL® force platform, 6 Minute Walk Test (6 MWT) will be performed with measuring heart rate (HR) and "Pulsed" oxygen saturation using Pulse oximeter - SpO2 saturometer. - Change in biological parameters :The complete blood count with Phenotyping of sub-leukocyte populations (Monocytes, lymphocytes), extraction of messenger RNA from blood mononuclear cells, change in neuronal growth factors (brain derived neurotropic factor and GDNF), change in blood glucose and lipid profile (Total Cholesterol (TC), High-density lipoprotein (HDL), Low density lipoprotein (LDL) and Triglycerides (TG)), 8-Change in inflammation: pro-inflammatory cytokines (IL-17, INF-?, IL-6, tumor necrosis factor…), reactive C protein, Change in hormones: Serum melatonin, Testosterone, Estrogen, Progesterone, Cortisol and Insulin concentrations, change in vitamins levels: D, E and A | — |
Countries
Tunisia
Contacts
Public ContactAbdelmoneem Yahia
The Research Unit of the assessment of musculoskeletal disorders
Outcome results
None listed