Effect of Resistance Training on Psychophysiological Indicators in People With Multiple Sclerosis

NCT07118514 | Completed

• 1 other identifier: 70726623.3.0000.0104
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial aims to investigate the effects of a supervised resistance training program on plasma levels of Brain-Derived Neurotrophic Factor (BDNF) and irisin in individuals diagnosed with multiple sclerosis (MS). The study will also examine secondary outcomes, including fatigue, quality of life, anxiety and depression symptoms, muscular strength, and functional capacity. Participants will be randomly assigned to either an intervention or control group in a 2:1 allocation ratio. The intervention group will undergo a 12-week supervised resistance training program, while the control group will maintain their usual care without engaging in any structured exercise regimen. The trial will be non-blinded and involve assessments at baseline and after the 12-week intervention period. Eligible participants must be adults (≥18 years), of any sex, with a confirmed diagnosis of MS by a neurologist, and currently undergoing disease-modifying therapy (DMT). Participants must not be engaged in any other structured physical exercise program, though symptom-management physiotherapy will be permitted. All participants should have sufficient mobility to complete the training sessions and assessments. Exclusion criteria include the inability to perform the physical training or functional tests due to severe mobility restrictions, lack of standard pharmacological treatment for MS, or concurrent participation in other structured exercise programs.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; BDNF; Irisin; Anxiety; Depression; Exercise; Quality of life; Fatigue

Outcome Measures

Primary Outcomes (1)

• Plasma levels of cortisol, brain-derived neurotrophic factor (BDNF), and irisin.

  Change in plasma concentrations of cortisol, BDNF and irisin, measured using enzyme-linked immunosorbent assay (ELISA).

  - Baseline - 12 weeks

Secondary Outcomes (11)

• Muscle Strength (Dynamic and Isokinetic)

  - Baseline - 12 weeks

• Functional Mobility

  - Baseline - 12 weeks

• Isokinetic Muscle Strength (Lower Limbs)

  - Baseline -12 weeks

• Fatigue

  - Baseline -12 weeks

• Anxiety and Depression

  - Baseline -12 weeks

Study Arms (2)

Exercise Group

EXPERIMENTAL

Participants in this group will undergo a 12-week supervised resistance training program, twice a week for approximately 50 minutes per session. Exercises are performed on fixed machines and based on 1-repetition maximum (1-RM) tests, with progressive loads from 50% to 65% of 1-RM. Training includes leg press, leg curl, knee extension, chest press, biceps and triceps curls, seated row, and lat pulldown

Behavioral: Progressive Resistance Training

Control Group

ACTIVE COMPARATOR

Participants in this group will engage in light stretching and relaxation sessions twice a week for 12 weeks. Each session lasts approximately 30-40 minutes and includes breathing exercises, stretching of major muscle groups, and guided relaxation.

Behavioral: Stretching and Relaxation Activities

Interventions

Progressive Resistance Training BEHAVIORAL

A 12-week supervised resistance training program, performed twice weekly for 50 minutes per session. Exercises are based on 1-repetition maximum (1-RM) tests, using fixed machines and progressive loads (50-65% of 1-RM). Exercises include leg press, leg curl, knee extension, chest press, biceps/triceps curls, seated row, and lat pulldown.

Also known as: Resistance training, Weight Training, Strength Training

Exercise Group

Stretching and Relaxation Activities BEHAVIORAL

A 12-week supervised program focused on flexibility and relaxation, performed twice weekly for approximately 50 minutes. Includes static stretching of major muscle groups and guided breathing exercises aimed at reducing muscle tension and promoting mental relaxation.

Also known as: Static Muscle Stretching, Dynamic Stretching, Flexibility Protocols

Control Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed diagnosis of Multiple Sclerosis (MS) according to the 2017 McDonald Criteria
• Expanded Disability Status Scale (EDSS) score between 1.0 and 6.0
• Age between 18 and 60 years
• Medical clearance to engage in physical exercise
• Ability to understand and provide written informed consent
• Stable pharmacological treatment for MS for at least 3 months prior to enrollment
• No MS relapses or corticosteroid use within 30 days before starting the intervention

You may not qualify if:

• Pregnancy or planning to become pregnant during the study period
• Severe musculoskeletal conditions contraindicating exercise
• Participation in another structured or systematic exercise program
• Visual, cognitive, or communication impairments that may hinder participation
• Use of orthopedic devices incompatible with the intervention protocols
• Any other condition that, in the opinion of the research team, may interfere with participation or compromise data integrity

Sponsors & Collaborators

• State University of Maringá: lead

Study Sites (1)

State University of Maringá

Maringá, Paraná, 87020-900, Brazil

Location

MeSH Terms

Conditions

Multiple Sclerosis; Anxiety Disorders; Depression; Motor Activity; Fatigue

Interventions

Resistance Training; Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Mental Disorders; Behavioral Symptoms; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomized in a 2:1 ratio to either an intervention group (supervised progressive resistance training) or a control group (light stretching and relaxation activities). The intervention will last 12 weeks, with two sessions per week. All outcomes will be assessed at baseline and post-intervention.

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: August 12, 2025
• Study Start: August 15, 2024
• Primary Completion: December 17, 2024
• Study Completion: December 17, 2024
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)