Effects of Resistance Training in Multiple Sclerosis: a Randomized Trial. (ACTIVE)

Hospital Clínico Universitario de Valladolid

Status: Enrolling

Conditions: Multiple Sclerosis

Treatments: Other: Low aerobic training; Other: Resistance training

Study type: Interventional

Funder types: Other

Identifiers

NCT06478784

PI-GR-23-3292

Details and patient eligibility

About

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.

Full description

Multiple sclerosis is a dysimmune and neurodegenerative disease of the central nervous system. Despite highly effective drug, multiple sclerosis represents the main cause of non-traumatic disability in young people. Interventions based on physical exercise have a positive impact on the course of the disease, although the pathophysiological mechanisms responsible for this benefit remain unknown. This project aims to investigate the impact of physical exercise on neuronal destruction in patients with multiple sclerosis.

To do this, the investigators will study the evolution of the concentrations of two markers of neuronal injury, acidic gliofibrillary protein (GFAP) and light chain neurofilaments (Nfl) in two groups of patients: a control group and a second group subjected to a supervised resistance physical exercise program performed during 10 weeks. Marker values will be compared before and after the intervention and between groups. The results will allow the investigators to delve into the pathophysiology of multiple sclerosis and the mechanism through which physical exercise impacts on the disease. In addition, the investigators will generate knowledge that will allow us to reinforce the idea of integrating physical exercise as part of the treatment in multiple sclerosis.

Project within the framework of the GRS(Gerencia Regional de Salud, Castilla y Léon) 28/10/A1/2023

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. • Diagnosis of multiple sclerosis according to the 2017 Mc Donald criteria (Thompson A et al).
2. • Age > 18 years - up to no age limit
3. • Disability assessed by the EDSS (Expanded disability status scale) with a score less than or equal to 4.
4. • Clinical stability. Not having had an outbreak of the disease in the last 6 months.
5. • No changes in the disease-modifying treatment in the last 6 months or no treatment.
6. • Radiological stability. Patients with last MRI (magnetic resonance imaging) performed without inflammatory activity (absence of new lesions on T2 sequences or lesions that enhance with gadolinium).
7. • They must sign the informed consent

Exclusion criteria

1. • 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
2. • Pregnant or breastfeeding patients.
3. • Concomitant pathologies that limit the performance of physical exercise

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

ACTIVE GROUP: Resistance training

Experimental group

Description:

The experimental group (ACTIVE GROUP) will perform a circuit-based muscular strength program at high intensity, three days per week for 10 weeks.

Treatment:

Other: Resistance training

CONTROL GROUP: Low intensity aerobic training

Active Comparator group

Description:

Patients assigned to this CONTROL GROUP will perform exercise in static bicycle.They will perform aerobic training at low-moderate intensity (50% of the maximum power developed in cycloergometer) for 45 minutes three days a week, with a duration of 10 weeks.

Treatment:

Other: Low aerobic training