Therapeutic effect of physical activity associated with melatonin or synbiotic consumption on biological, psycho-cognitive and physiological adaptations in multiple sclerosis patients

Phase 3

• Conditions: Nervous System Diseases

• Registration Number: PACTR202007465309582
• Lead Sponsor: The Research Unit of the assessment of musculoskeletal disorders

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-03
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

*Patients under 60 years old
*Sedentary.
*No diet
*EDSS : from 0 to 5
*Body mass index (BMI) <30 (kg/m²)

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified