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

NCT ID: NCT06478784

Last Updated: 2024-06-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2025-01-30

Brief Summary

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.

Detailed 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

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

ACTIVE GROUP: Resistance training

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

Group Type: EXPERIMENTAL

Resistance training

Intervention Type: OTHER

The 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.

CONTROL GROUP: Low intensity aerobic training

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.

Group Type: ACTIVE_COMPARATOR

Low aerobic training

Intervention Type: OTHER

Patients 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.

Interventions

Resistance training

The 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.

Intervention Type: OTHER

Low aerobic training

Patients 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European University Miguel de Cervantes

OTHER

Sponsor Role: collaborator

Hospital Clínico Universitario de Valladolid

OTHER

Sponsor Role: lead

Responsible Party

Alba Chavarria

Alba Chavarria Miranda, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alba Chavarria Miranda, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clínico Universitario de Valladolid

Locations

Hospital Clínico Universitario de Valladolid

Valladolid, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Alba Chavarria Miranda, MD

Role: CONTACT

achavarria@saludcastillayleon.es

0034983420000

Facility Contacts

Alba Chavarria Miranda, MD

Role: primary

References

Mulero P, Maroto-Izquierdo S, Redondo N, Gonzalo-Benito H, Chavarria-Miranda A, Calvo H, Cabero MI, Hernandez M, Nieto ML, Tellez N. Effect of resistance exercise training on plasma neurofilaments in multiple sclerosis: a proof of concept for future designs. Neurol Sci. 2023 Nov;44(11):3997-4000. doi: 10.1007/s10072-023-06896-5. Epub 2023 Jun 19.

Reference Type: RESULT

PMID: 37335403 (View on PubMed)

Other Identifiers

PI-GR-23-3292

Identifier Type: -

Identifier Source: org_study_id