Exercise-Induced Irisin and Brain Changes

Firat University

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Other: Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT07101653

2024/13-37

Details and patient eligibility

About

This single-blind, randomized controlled trial will employ a two-arm parallel design (exercise group vs. control group) with a 12-week intervention period. Sex-stratified randomization will be implemented using SPSS 25.0 (IBM Corporation, Armonk, NY, USA) to ensure balanced group allocation. All outcome measures will be assessed at baseline and post-intervention.

Full description

The exercise intervention will consist of supervised progressive resistance training sessions conducted three times weekly (with a minimum 48-hour rest period between sessions) at Firat University Hospital. Control participants will maintain their usual daily activities without participating in any structured exercise programs.

A blinded neurologist will perform all clinical assessments to eliminate measurement bias. To control for circadian variations, all evaluations will be scheduled at consistent times of day for each participant. Environmental conditions will be strictly maintained during testing sessions (ambient temperature: 21-22°C; humidity: 55-60%).

This study will be designed and reported in accordance with CONSORT guidelines for randomized trials, incorporating all essential elements for transparent randomized controlled reporting, including allocation concealment, blinding procedures, and intention-to-treat principles.

Enrollment: 21 patients

Sex: All

Ages: 19 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinically confirmed relapsing-remitting multiple sclerosis (RRMS) diagnosis according to revised McDonald criteria (2017)
• Aged 19-65 years (inclusive)
• Mild-to-moderate disability (EDSS score 1.0-5.5)
• No corticosteroid treatment within the previous 3 months

Exclusion criteria

• Acute MS relapse within 90 days prior to enrollment
• Regular participation in structured exercise programs (>3 hours/week)
• Comorbid conditions that may limit exercise participation, including; significant orthopedic impairments, unstable cardiopulmonary conditions and other systemic disorders affecting physical activity
• Standard MRI contraindications (metallic implants, claustrophobia, etc.)
• Concurrent neurological disorders (other than MS)
• Initiation or modification of disease-modifying therapy within 6 months
• Severe spasticity (Modified Ashworth Scale ≥3 in any major muscle group)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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21 participants in 2 patient groups

Exercise

Experimental group

Description:

Based on current recommendations for individuals with MS, the PRT program will last 12 weeks and will include three sessions per week, each lasting 60-90 minutes at 60-80% of one-repetition maximum.

Treatment:

Other: Exercise

No intervantion

No Intervention group

Description:

No intervantion