EFFECTS OF AEROBIC AND RESISTANCE TRAINING ON IMMUNE FUNCTION IN MULTIPLE SCLEROSIS

NCT07640100 | Not Yet Recruiting

• 1 other identifier: KAD-FR-42
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Multiple Sclerosis (MS) is a chronic immune-mediated, inflammatory, and neurodegenerative central nervous system disorder characterized by axonal damage. This damage leads to various debilitating symptoms such as muscle weakness, fatigue, balance loss, and cognitive decline. While reductions in aerobic capacity and muscle strength are secondary manifestations of MS, physical exercise serves as a crucial therapeutic strategy to manage symptoms and optimize functionality. Rationale: Aerobic exercise exerts anti-inflammatory effects by reducing adipose tissue mass, promoting anti-inflammatory macrophage polarization, and downregulating toll-like receptors. It also modulates the altered T-helper cytokine balance in MS (characterized by elevated proinflammatory cytokines like IL-1, IL-6, IL-17, IFN-γ, TNF-α and decreased anti-inflammatory IL-10), potentially slowing myelin destruction. Concurrently, progressive resistance training (typically at 60%-80% of maximum voluntary contraction) has been shown to improve muscle strength and reduce perceived fatigue in this population. However, data regarding the specific impacts of these exercise modalities on the immune system remain limited. Objective:The aim of this randomized controlled trial is to investigate and compare the effects of AEROBIC AND STRENGTHENING (RESISTANCE) EXERCISES ON THE IMMUNE SYSTEM PARAMETERS (SPECIFICALLY CYTOKINE PROFILES) AND OVERALL FUNCTIONALITY IN INDIVIDUALS DIAGNOSED WITH MULTIPLE SCLEROSIS.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Physical Functional Performance; Cytokines; Immune System

Outcome Measures

Primary Outcomes (1)

• CHANGE FROM BASELINE IN SERUM PROINFLAMMATORY CYTOKINE LEVELS

  Circulating serum levels of proinflammatory cytokines-specifically Interleukin-1 (IL-1), Interleukin-6 (IL-6), Interleukin-17 (IL-17), Interferon-gamma (IFN-γ), and Tumor Necrosis Factor-alpha (TNF-α)-will be analyzed via Enzyme-Linked Immunosorbent Assay (ELISA) to evaluate the anti-inflammatory effect of the exercise program.

  Baseline and Post-intervention (e.g., Week 8)

Secondary Outcomes (5)

• CHANGE FROM BASELINE IN FUNCTIONAL EXERCISE CAPACITY

  Baseline and Post-intervention (e.g., Week 8)

• CHANGE FROM BASELINE IN TIMED 25-FOOT WALK (T25FW)

  Baseline and Post-intervention (e.g., Week 8)

• CHANGE FROM BASELINE IN PERCEIVED FATIGUE IMPACT

  Baseline and Post-intervention (e.g., Week 8)

• CHANGE FROM BASELINE IN 9-HOLE PEG TEST (9HPT)

  Baseline and Post-intervention (e.g., Week 8)

• CHANGE FROM BASELINE IN PACED AUDITORY SERIAL ADDITION TEST (PASAT-3)

  Baseline and Post-intervention (e.g., Week 8)

Study Arms (3)

MS Exercise group

EXPERIMENTAL

Participants diagnosed with Multiple Sclerosis who will perform a structured exercise program consisting of both aerobic training and progressive strengthening (resistance) exercises.

Behavioral: Aerobic and Progressive Resistance Exercise Program

MS Control Group

ACTIVE COMPARATOR

Participants diagnosed with Multiple Sclerosis who will maintain their current routine medical care and daily life activities without participating in any structured exercise intervention during the study period.

Other: Standard Care (in control arm)

healthy Control Group

EXPERIMENTAL

Age- and gender-matched healthy individuals who will perform the identical structured exercise program (consisting of aerobic and progressive strengthening exercises) as the MS Exercise Group. This arm will serve to compare the physiological, functional, and immunological (cytokine profiles) responses to exercise between healthy individuals and individuals with MS.

Behavioral: Aerobic and Progressive Resistance Exercise Program

Interventions

Aerobic and Progressive Resistance Exercise Program BEHAVIORAL

A structured, supervised exercise program consisting of both aerobic and progressive strengthening (resistance) exercises. Aerobic exercises will include continuous, rhythmic activities involving large muscle groups (e.g., cycle ergometry, walking). Progressive resistance training will target major muscle groups, typically utilizing an intensity ranging from 60% to 80% of the maximum voluntary contraction (MVC). The duration, frequency, and total weeks of the program will be identical for both exercise arms.

MS Exercise group; healthy Control Group

Standard Care (in control arm) OTHER

Participants in this arm will maintain their current routine medical follow-ups and standard daily life activities. They will not participate in any structured or supervised physical exercise program during the study period.

MS Control Group

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosed with Relapsing-Remitting Multiple Sclerosis (RRMS). Aged between 19 and 45 years. Expanded Disability Status Scale (EDSS) score between 0.5 and 3.5. Not currently receiving steroid therapy (or having no recent corticosteroid treatment within the specified washout period).

You may not qualify if:

• Having a high baseline level of physical activity.
• Experiencing an acute MS relapse or having a history of a relapse within the past 3 months.
• Presence of any orthopedic or bone pathology that would prevent participation in the exercise program.
• Concomitant diagnosis of any known neuromuscular or immunological disease other than MS.
• Initiating immunomodulatory therapy within the last 6 months.
• Presence of visual involvement or symptomatic diplopia.
• High-grade lower extremity spasticity, defined as a Modified Ashworth Scale (MAS) score of 3 or 4.
• Abnormal white blood cell (WBC) count outside the normal reference range of 4,000-10,000 cells/µL.
• Presence of any severe cardiopulmonary condition that would contraindicate or prevent participation in physical exercise.

Sponsors & Collaborators

• Seda Saka: lead

Study Sites (1)

Van Regional Training and Research Hospital

Van, Ipekyolu, 65100, Turkey (Türkiye)

Location

Related Links

• ACUTE EFFECTS OF AEROBIC INTENSITIES ON THE CYTOKINE RESPONSE IN WOMEN WITH T MILD MULTIPLE SCLEROSIS
• INFLUENCE OF COMBINED FUNCTIONAL RESISTANCE AND ENDURANCE EXERCISE OVER 12 WEEKS ON MATRIX METALLOPROTEINASE-2 SERUM CONCENTRATION IN PERSONS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS - A COMMUNITY-BASED RANDOMIZED CONTROLLED TRIAL

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• seda saka, Assoc. Prof. Dr.

  Haliç University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

berna beren yıldırımoğlu, specialist physiotherapist

CONTACT

+905550823309; calppberna@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Due to the nature of the physical exercise intervention, participants and the physical therapists providing the training cannot be blinded. However, the outcomes assessor who conducts the clinical and functional assessments, as well as the laboratory personnel analyzing the immune system parameters (cytokine profiles), will be blinded to the group allocations.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assoc. Prof. Dr.

Model Details: This is a 3-arm, prospective, randomized controlled trial utilizing a parallel assignment design. Participants will be allocated into three distinct groups: MS Exercise Group (Experimental Arm): Individuals diagnosed with MS who will undergo a structured aerobic and strengthening exercise program. MS Control Group (Active/No Intervention Arm): Individuals diagnosed with MS who will maintain their routine medical care without participating in the exercise intervention. Healthy Control Group (Comparison Arm): Age- and gender-matched healthy individuals who will serve as a baseline reference for immune system parameters and functional capacity. The clinical, functional, and immunological outcomes (cytokine profiles) of all groups will be evaluated simultaneously at baseline and post-intervention to compare the treatment effects and baseline differences.

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 10, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)