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

Effects of Resistance Training in Multiple Sclerosis: a Randomized Trial. ACTIVE (Physical Activity and Its Impact on Patients With Multiple Sclerosis.)

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.

Study Overview

• Status: Recruiting
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: Resistance training; Other: Low aerobic training

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

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alba Chavarria Miranda, MD; Phone Number: 0034983420000; Email: achavarria@saludcastillayleon.es

Study Locations

• Spain
  • Valladolid, Spain, 47003
    • Recruiting
    • Hospital Clinico Universitario de Valladolid
    • Contact: Alba Chavarria Miranda, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	10 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	10 weeks

Collaborators and Investigators

• Sponsor: Hospital Clínico Universitario de Valladolid
• Collaborators: European University Miguel de Cervantes
• Investigators: Principal Investigator: Alba Chavarria Miranda, MD, Hospital Clinico Universitario de Valladolid

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): January 30, 2025

Study Registration Dates

• First Submitted: May 1, 2024
• First Submitted That Met QC Criteria: June 24, 2024
• First Posted (Actual): June 27, 2024

Study Record Updates

• Last Update Posted (Actual): June 27, 2024
• Last Update Submitted That Met QC Criteria: June 24, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: physical exercise; resistance training; GFAP; neurofilaments
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: PI-GR-23-3292

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No