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Multiple SclerosisABIF-MSNCT07640100

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

A study testing Aerobic and Progressive Resistance Exercise Program in people with Multiple Sclerosis, run by Seda Saka at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Multiple Sclerosis
What is being tested?
Aerobic and Progressive Resistance Exercise Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jun 2026to 30 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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).

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

berna beren yıldırımoğlu, specialist physiotherapist contact

+905550823309

calppberna@hotmail.com

Turkey (Türkiye)1 site
  • Van Regional Training and Research Hospital

    Van, Ipekyolu, 65100

    VAN REGIONAL TRAINING AND RESEARCH HOSPITAL REGIONAL TRAINING AND RESEARCH HOSPITAL, +905555798488, dr_m_okay@hotmail.com

    muhammed örün, specialist, +905555798488, dr_m_okay@hotmail.com

Other trials in Turkey (Türkiye)

About this study

Official title: EVALUATION OF THE EFFECTS OF AEROBIC AND RESISTANCE EXERCISES ON THE IMMUNE SYSTEM AND FUNCTIONAL CAPACITY IN MULTIPLE SCLEROSIS

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.

Read the detailed description

Multiple Sclerosis (MS) is recognized as a chronic immune-mediated, inflammatory, and neurodegenerative disorder of the central nervous system (CNS) characterized by axonal damage that disrupts neural conduction. The neurodegenerative nature of this neurological disease manifests through a wide spectrum of debilitating symptoms, including muscle weakness, fatigue, loss of balance, speech impairment, diplopia, and cognitive decline. These neurological signs and symptoms vary depending on the anatomical location of the lesions.

As an effective rehabilitation strategy for individuals with MS, exercise manages symptoms, restores function, optimizes quality of life, promotes wellness, and encourages participation in activities of daily living. Previous studies have demonstrated that aerobic activity is inversely associated with MS symptoms, exerting protective and potentially restorative effects. Furthermore, growing evidence suggests that exercise can be considered a disease-modifying therapy in MS. Although reductions in aerobic capacity and endurance are not primary clinical features of MS, they frequently develop as secondary manifestations. Therefore, strategies designed to enhance aerobic endurance and capacity, such as aerobic exercise, are highly valuable in MS management. Consequently, aerobic-based exercise interventions are frequently utilized in the therapeutic management of MS to improve aerobic endurance and capacity. Aerobik exercise is a modality designed to stress the cardiovascular system through continuous, rhythmic engagement of large muscle groups (e.g., jogging, walking, swimming, rowing, and cycle ergometry).

The anti-inflammatory effect of aerobic exercise may prevent systemic inflammatory progression. Exercise counteracts inflammation by reducing adipose tissue mass, which promotes the polarization of macrophages toward an anti-inflammatory state, thereby limiting cytokine production. Additionally, the downregulation of toll-like receptors associated with decreased inflammatory monocytes occurs. The inflammatory state is also modulated in response to exercise stimulation by increased levels of skeletal muscle-derived interleukin-6 (IL-6) and the prevention of sustained cytokine release associated with obesity. Cytokines, critical components of MS pathophysiology, are protein hormones that regulate communication between the innate and adaptive branches of the immune system. In healthy populations, a homeostatic balance exists among T-helper cytokines; however, this balance is altered in MS, reflecting increased proinflammatory cytokines (IL-1, IL-6) and decreased anti-inflammatory cytokines (IL-10). These aberrations can accelerate myelin destruction in the brain and spinal cord. Data regarding the effects of physical activity on the immune system in MS remain limited. Cytokines, the primary focus of exercise-based MS studies, encompass a spectrum of proinflammatory cytokines, including IL-1, IL-2, IL-6, IL-17, interferon-gamma (IFN-γ), and tumor necrosis factor-alpha (TNF-α). Most of these cytokines are well-documented contributors to MS pathogenesis.

Recently, there has been a growing interest in resistance exercise training. Resistance training studies in individuals with MS have reported improvements in leg strength, reductions in perceived fatigue, and increases in muscle power. Resistance training protocols in this population have generally been of low-to-moderate intensity, typically utilizing progressive resistance exercise ranging from 60% to 80% of the maximum voluntary contraction.

The aim of this study is to conduct a randomized controlled trial to investigate the EFFECTS OF AEROBIC AND STRENGTHENING EXERCISES ON THE IMMUNE SYSTEM AND FUNCTIONALITY IN INDIVIDUALS DIAGNOSED WITH MULTIPLE SCLEROSIS.

Being tested
Aerobic and Progressive Resistance Exercise Program, Standard Care (in control arm)
Keywords
Multiple Sclerosis, Physical Functional Performance, Cytokines, Immune System
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aerobic and Progressive Resistance Exercise ProgramBehavioural

    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.

  • 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.

Study groups in NCT07640100
Study groupRoleWhat they receive
MS Exercise groupExperimentalParticipants diagnosed with Multiple Sclerosis who will perform a structured exercise program consisting of both aerobic training and progressive strengthening (resistance) exercises.
Receives: Behavioral: Aerobic and Progressive Resistance Exercise Program
MS Control GroupActive comparatorParticipants 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.
Receives: Other: Standard Care (in control arm)
healthy Control GroupExperimentalAge- 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.
Receives: Behavioral: Aerobic and Progressive Resistance Exercise Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (5)
  1. CHANGE FROM BASELINE IN FUNCTIONAL EXERCISE CAPACITY

    Evaluated using the 6-Minute Walk Test (6MWT). The total distance walked in meters within 6 minutes will be recorded to assess functional exercise capacity and aerobic endurance.

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

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

    A MEASURE OF QUANTITATIVE MOBILITY AND LEG FUNCTION BASED ON THE TIME REQUIRED TO WALK 25 FEET AS QUICKLY AS POSSIBLE.

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

  3. CHANGE FROM BASELINE IN PERCEIVED FATIGUE IMPACT

    Assessed using the Modified Fatigue Impact Scale (MFIS). This 21-item self-report questionnaire evaluates the perceived impact of fatigue on physical, cognitive, and psychosocial functioning. Total scores range from 0 to 84, with higher scores indicating a greater negative impact of fatigue.

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

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

    A MEASURE OF UPPER EXTREMITY (ARM AND HAND) FUNCTION BASED ON THE TIME REQUIRED TO PLACE AND REMOVE 9 PEGS IN A PEG BOARD.

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

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

    A MEASURE OF COGNITIVE FUNCTION, AUDITORY INFORMATION PROCESSING SPEED, AND CALCULATION ABILITY.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2026
  2. Study start1 Jun 2026 (estimated)
  3. Primary completion30 Aug 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Care provider
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07640100
Sponsor's protocol ID
KAD-FR-42
Acronym
ABIF-MS
Status last verified
Jun 2026
First submitted
2 Jun 2026
Last updated
10 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) collected during this trial will not be shared publicly to ensure patient confidentiality and comply with local data protection laws (Personal Data Protection Law / KVKK) and the institutional ethics committee approval. The ethical approval and informed consent forms signed by the participants do not cover the public repository sharing of raw individual data. However, the aggregated summary results and statistical findings will be made available through peer-reviewed publications.

Questions about this trial

What is this clinical trial studying?

A study testing Aerobic and Progressive Resistance Exercise Program in people with Multiple Sclerosis, run by Seda Saka at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact berna beren yıldırımoğlu, specialist physiotherapist (+905550823309, calppberna@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CHANGE FROM BASELINE IN SERUM PROINFLAMMATORY CYTOKINE LEVELS (time frame: Baseline and Post-intervention (e.g., Week 8)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.

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