Exercise-Induced Irisin and Brain Changes

NCT ID: NCT07101653

Last Updated: 2025-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-15
• Study Completion Date: 2025-06-15

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.

Detailed 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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Exercise

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.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: 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

No intervantion

No intervantion

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Exercise

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

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Firat University

OTHER

Sponsor Role: lead

Responsible Party

Furkan Bilek

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fırat University

Elâzığ, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2024/13-37

Identifier Type: -

Identifier Source: org_study_id