PACTR202007465309582
Completed
Phase 3
Effect of concurent training (strength and endurance) on biochemical and neurophysiological adaptations and physical and psycho-cognitive performance in people with multiple sclerosis: role of melatonin or synbiotics supplementation
The Research Unit of the assessment of musculoskeletal disorders0 sites60 target enrollmentJune 3, 2020
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- The Research Unit of the assessment of musculoskeletal disorders
- Enrollment
- 60
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\*Patients under 60 years old
- •\*Sedentary.
- •\*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
Outcomes
Primary Outcomes
Not specified
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