NCT07520812

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. 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for not_applicable multiple-sclerosis

Timeline
2mo left

Started Apr 2026

Shorter than P25 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress50%
Apr 2026Aug 2026

First Submitted

Initial submission to the registry

April 3, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 9, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

April 15, 2026

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2026

Expected
Last Updated

April 9, 2026

Status Verified

April 1, 2026

Enrollment Period

15 days

First QC Date

April 3, 2026

Last Update Submit

April 3, 2026

Conditions

Multiple SclerosisExerciseNeurofilament Light Chain

Keywords

ExerciseNeurofilament light chainBrain 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 Neurofilament Light Chain (NfL) 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 ng/ml will be used for serum Neurofilament Light Chain.

    12 Weeks

Secondary Outcomes (5)

  • Multiple Sclerosis Functional Composite

    12 Weeks

  • Fatigue Impact Scale

    12 Weeks

  • Short form-12 version 2 (SF-12v2)

    12 Weeks

  • Problem-Solving inventory (PSI)

    12 Weeks

  • Emotional intelligence scale (EIS)

    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

Control

NO INTERVENTION

Interventions

ExerciseOTHER

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

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinically confirmed relapsing-remitting multiple sclerosis (RRMS) diagnosis according to revised McDonald criteria (2017)
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fırat University

Elâzığ, 23100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple SclerosisMotor ActivityCharcot-Marie-Tooth disease, Type 1F

Interventions

Exercise

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Furkan Bilek, PhD

CONTACT

+905442772249fzt.furkanbilek@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
All clinical assessments will be performed by a blinded neurologist to eliminate measurement bias.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This single-blind, randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 3, 2026

First Posted

April 9, 2026

Study Start

April 15, 2026

Primary Completion

April 30, 2026

Study Completion (Estimated)

August 15, 2026

Last Updated

April 9, 2026

Record last verified: 2026-04

Locations

TU(1)