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

NCT06478784 | Recruiting

• 1 other identifier: PI-GR-23-3292
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

physical exercise; resistance training; neurofilaments; GFAP

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Comparison of plasma Glial fibrillary acidic protein (GFAP) level

  10 weeks

Study Arms (2)

ACTIVE GROUP: Resistance training

EXPERIMENTAL

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

CONTROL GROUP: Low intensity aerobic training

ACTIVE COMPARATOR

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

Interventions

Resistance training 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.

ACTIVE GROUP: Resistance training

Low aerobic training 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.

CONTROL GROUP: Low intensity aerobic training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.
• \- No changes in the disease-modifying treatment in the last 6 months or no treatment.
• \- 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).
• \- They must sign the informed consent

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Hospital Clínico Universitario de Valladolid: lead
• European University Miguel de Cervantes: collaborator

Study Sites (1)

Hospital Clínico Universitario de Valladolid

Valladolid, 47003, Spain

RECRUITING

Related Publications (1)

• 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.

  PMID: 37335403 RESULT

MeSH Terms

Conditions

Multiple Sclerosis; Motor Activity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Alba Chavarria Miranda, MD

  Hospital Clínico Universitario de Valladolid

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alba Chavarria Miranda, MD

CONTACT

0034983420000; achavarria@saludcastillayleon.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: A double-blind system will be maintained in which the exploring neurologists and the patient will not know the assigned therapeutic group. Randomly assigned to one or the other group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Alba Chavarria Miranda, MD

Model Details: We will include patients with multiple sclerosis in the ACTIVE GROUP (resistance training) and patients with multiple sclerosis CONTROL GROUP (low intensity aerobic training).

Study Record Dates

• First Submitted: May 1, 2024
• First Posted: June 27, 2024
• Study Start: January 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: January 30, 2025
• Last Updated: June 27, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)