About this trial
This is a longitudinal study to examine the effects of a short-term training program on neurofilamet and GFAP plasma levels. Participants will be divided in two groups: control group (moderate aerobic training) and active group (resistance training). The change in biomarkers will be analyzed pre and post intervention in both groups. Differences between groups will be also evaluated by investigators.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
- Diagnosis of multiple sclerosis according to the 2017 Mc Donald criteria (Thompson A et al).
- Age > 18 years - up to no age limit
- Disability assessed by the EDSS (Expanded disability status scale) with a score less than or equal to 4.
- Clinical stability. Not having had an outbreak of the disease in the last 6 months.
Disqualifiers
- Patients with a high level of physical activity according to the International Physical Activity Questionnaire(IPAQ) or latest WHO (World Health Organization) recommendations on physical activity
- Pregnant or breastfeeding patients.
- Concomitant pathologies that limit the performance of physical exercise
Trial design
Parallel
Treatments tested in this trial
Resistance training
Other interventionThe experimental group (ACTIVE GROUP) will perform a circuit-based muscular strength program at high intensity three days per week for 10 weeks. Each session will last approximately 45 minutes. The Resistance training program will be supervised by staff from the Department of Health Sciences and Sports of the Miguel de Cervantes European University of Valladolid and will be carried out at the facilities of the Miguel de Cervantes European University of Valladolid.
Low aerobic training
Other interventionPatients assigned to this group will perform exercise in static bicycle during 45 minutes three days a week, with a duration of 10 weeks. This second group, despite performing the aerobic exercise, is considered control, since they will perform low-intensity aerobic exercise (50% of the maximum power developed in cycloergometer) The Resistance training program will be supervised by staff from the Department of Health Sciences and Sports of the Miguel de Cervantes European University of Valladolid and will be carried out at the facilities of the Miguel de Cervantes European University of Valladolid.
Treatment groups
Trial outcomes
Primary outcomes
Comparison of plasma light chain neurofilaments (Nfl) level
To evaluate the change of plasma neurofilament concentrations (pg/mL) between the two groups of multiple sclerosis patients, the control group that will perform moderate aerobic exercise vs. the group subjected to the resistance training intervention.
Secondary outcomes
Comparison of plasma Glial fibrillary acidic protein (GFAP) level
To study the change of plasma Glial fibrillary acidic protein (GFAP)(pg/mL) between the two groups of multiple sclerosis patients, the control group that will perform moderate aerobic exercise vs. the group subjected to the resistance training intervention.
Sponsors and contacts
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Hospital Clínico Universitario de Valladolid
Lead sponsor
European University Miguel de Cervantes
Collaborator