Exercise-Induced Irisin and Brain Changes

NCT07101653 | Completed

• 1 other identifier: 2024/13-37
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis

Keywords

Exercise; Irisin; Brain Volume

Outcome Measures

Primary Outcomes (2)

• MRI Acquisition and Volumetric Analysis

  Volumetric brain analysis will be conducted using VolBrain, an open-access automated segmentation platform for brain MRI.

  12 weeks

• Serum irisin hormone measurement

  All patients will be asked to provide blood samples in the morning following their overnight (12 h) fast before and after the study. The unit pg/ml will be used for serum irisin.

  12 weeks

Secondary Outcomes (1)

• Multiple Sclerosis Functional Composite

  12 weeks

Study Arms (2)

Exercise

EXPERIMENTAL

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.

Other: Exercise

No intervantion

NO INTERVENTION

No intervantion

Interventions

Exercise OTHER

According to current clinical guidelines for multiple sclerosis patients, the progressive resistance training (PRT) protocol will be implemented as follows: a 12-week intervention consisting of three supervised 60-90 minute sessions per week at 60-80% of one-repetition maximum intensity. All training sessions will be conducted under the direct supervision of a certified physiotherapist to ensure proper technique adherence and safety throughout the intervention period

Exercise

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Firat University: lead

Study Sites (1)

Fırat University

Elâzığ, 23100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple Sclerosis; Motor Activity

Interventions

Exercise

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)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: All clinical assessments will be performed by a blinded neurologist to eliminate measurement bias.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This single-blind, randomized controlled trial

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: August 3, 2025
• Study Start: October 15, 2024
• Primary Completion: November 15, 2024
• Study Completion: June 15, 2025
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)