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

State University of Maringá

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Behavioral: Progressive Resistance Training; Behavioral: Stretching and Relaxation Activities

Study type: Interventional

Funder types: Other

Identifiers

NCT07118514

70726623.3.0000.0104

Details and patient eligibility

About

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.

Full description

This randomized controlled trial investigates the effects of a 20-week progressive resistance training program on psychophysiological parameters in individuals with multiple sclerosis (MS). The study compares a resistance-training intervention group with an active control group performing stretching and relaxation exercises, aiming to determine changes in hormonal, immunological, motor, and psychological outcomes.

MS is a chronic, immune-mediated demyelinating disease of the central nervous system, associated with neuroinflammation, neurodegeneration, and significant variability in clinical presentation. Common symptoms such as fatigue, depression, and motor impairment severely impact quality of life. Research suggests that exercise can promote neuroprotection, modulate inflammatory processes, and improve both physical and psychological well-being in this population.

The intervention is based on established exercise guidelines for mild to moderate MS and is adapted from protocols demonstrating safety and feasibility in this population. It seeks to investigate simultaneous effects on circulating biomarkers - including brain-derived neurotrophic factor (BDNF), irisin, vitamin D, cortisol, vascular endothelial growth factor (VEGF), nerve growth factor (NGF), neurotrophin-3 (NT-3), and neurotrophin-4 (NT-4) - alongside functional capacity, muscle strength, body composition, and validated measures of fatigue, quality of life, anxiety, depression, motivation, and habitual physical activity.

Assessments are conducted before and after the intervention period, with all laboratory analyses performed under standardized fasting and sample-processing conditions. Functional and psychological measures are obtained using validated instruments for the Brazilian population. Participants are monitored to ensure high adherence rates, with makeup sessions provided when possible.

This trial addresses a gap in the literature by jointly evaluating neurotrophic, hormonal, motor, and psychological responses to structured exercise in Brazilian individuals with MS, and by including an active control condition to account for the potential influence of social interaction and attention. The findings may inform future rehabilitation strategies and complement pharmacological management, contributing to improved patient outcomes.

Enrollment: 40 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

40 participants in 2 patient groups

Exercise Group

Experimental group

Description:

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

Treatment:

Behavioral: Progressive Resistance Training

Control Group

Active Comparator group

Description:

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.

Treatment:

Behavioral: Stretching and Relaxation Activities