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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| No intervantion | No Intervention | No intervantion |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Multiple Sclerosis Functional Composite | Multiple Sclerosis Functional Composite (MSFC) is a standardized, quantitative tool used to assess disability and functional changes in individuals with multiple sclerosis (MS). | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fırat University | Elâzığ | 23100 | Turkey (Türkiye) |
I dont want to share IPD with other researchers
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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This single-blind, randomized controlled trial
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All clinical assessments will be performed by a blinded neurologist to eliminate measurement bias.
|
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001519 | Behavior |