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IRCT20220603055067N5 IRCT 2026-08-21 University of Guilan The Impact of Exercise on Multiple Sclerosis (MS) Effects of Resistance, Aerobic, and Combination Training on serotonin and dopamine pathway and some Inflammatory Markers in Women with Multiple Sclerosis 2026-08-29 anticipated 52 Recruiting https://irct.ir/trial/78395 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, we randomly allocated 40 women with relapsing-remitting MS to four groups (resistance, aerobic, combined exercise, and control) at the individual level, with 10 participants per group. We used simple randomization with no stratification. Each participant was assigned a number from 1 to 40; we drew the numbers by lottery and allocated them in sequence to the four groups until each group had 10 participants. Allocation concealment was ensured by having a person not involved in recruitment or outcome assessment perform the draw, and group assignments were kept concealed until after baseline measurements, Blinding description: Because of the nature of the exercise intervention, participants and the trainers who delivered the sessions could not be blinded to group allocation; each participant necessarily knew which type of training (aerobic, resistance, combined, or control) she received. Blinding was therefore applied to outcome assessment and data analysis. Blood samples for biomarker measurement (serotonin, dopamine, IL-17, IFN-γ, FoxP3) were labeled with codes only, so the laboratory personnel measuring the outcomes were unaware of each participant's group. The statistician analyzed the data using coded group labels (A, B, C, D) and was unblinded only after the analysis was complete. On this basis the study is single-blind (outcome assessor– and analyst–blinded). N/A Multiple sclerosis. Intervention 1: Intervention Group 1 (Aerobic Training):Participants in this group performed a supervised aerobic exercise program for 8 weeks, 2 to 3 sessions per week (starting at 2 sessions/week and gradually increasing to 3 sessions/week). Each session consisted of a 5-minute warm-up (light walking or cycling combined with dynamic stretching), 10 to 30 minutes of main aerobic exercise at 40–60% of peak heart rate, and a 5-minute cool-down (gradual reduction of activity intensity along with static stretching of the muscles used). Intervention 2: Intervention Group 2 (Resistance Training):Participants in this group performed a supervised resistance training program for 8 weeks, 3 sessions per week. Each session consisted of a 5-minute general warm-up (light aerobic activity combined with dynamic stretching to prepare the joints and muscles), 10 to 30 minutes of main resistance exercise (including weighted or resistance-based movements targeting major muscle groups), and a 5-minute cool-down (static stretching of the worked muscles).Intervention group:. Intervention 3: Intervention Group 3 (Combined Training):Participants in this group performed a combination of aerobic and resistance exercises for 8 weeks, 2 to 3 sessions per week. The two types of training alternated on a weekly basis, and their intensity and volume were similar to those of the aerobic and resistance groups. Regardless of the type of training scheduled for that week, each session began with a 5-minute warm-up (light aerobic activity and dynamic stretching) and ended with a 5-minute cool-down (gradual reduction of intensity and static stretching). Intervention 4: Control group: Participants in this group did not receive any exercise intervention during the 8-week study period and continued their usual daily activities. No - There is not a plan to make this available Justification or reason for not sharing IPD is These data are confidential, and only researchers will have access to them
public Payam Saidie
5th Kilometer of Persian Gulf Highway, Rasht, Guilan Province, Iran
Rasht Iran (Islamic Republic of) ۴۱۹۹۶۱۳۷۷۶ +98 13 3369 0274 saidie-p@guilan.ac.ir University of guilan scientific Payam Saidie
5th Kilometer of Persian Gulf Highway, Rasht
Rasht Iran (Islamic Republic of) 4199613776 +98 911 194 3804 payam.saidie@gmail.com University of Guilan Iran (Islamic Republic of) Having a depressive disorder Age range between 25 and 50 years having anxiety EDSS between 0.5 - 5.0 Absence of diseases such as: fatty liver, thyroid, kidney disease, cardiovascular disease Having at least 2 months gap from exercising No smoking No alcohol consumption Having a relapsing-remitting disease 25 years 50 years Female Use of antidepressant, anti-anxiety, or other psychiatric medications Acute infection or use of anti-inflammatory / immunomodulatory drugs at study entry Musculoskeletal, orthopedic, or cardiopulmonary conditions preventing safe participation in the exercise program G35 Multiple sclerosis Rehabilitation Rehabilitation Rehabilitation N/A Intervention Group 1 (Aerobic Training):Participants in this group performed a supervised aerobic exercise program for 8 weeks, 2 to 3 sessions per week (starting at 2 sessions/week and gradually increasing to 3 sessions/week). Each session consisted of a 5-minute warm-up (light walking or cycling combined with dynamic stretching), 10 to 30 minutes of main aerobic exercise at 40–60% of peak heart rate, and a 5-minute cool-down (gradual reduction of activity intensity along with static stretching of the muscles used). Intervention Group 2 (Resistance Training):Participants in this group performed a supervised resistance training program for 8 weeks, 3 sessions per week. Each session consisted of a 5-minute general warm-up (light aerobic activity combined with dynamic stretching to prepare the joints and muscles), 10 to 30 minutes of main resistance exercise (including weighted or resistance-based movements targeting major muscle groups), and a 5-minute cool-down (static stretching of the worked muscles).Intervention group: Intervention Group 3 (Combined Training):Participants in this group performed a combination of aerobic and resistance exercises for 8 weeks, 2 to 3 sessions per week. The two types of training alternated on a weekly basis, and their intensity and volume were similar to those of the aerobic and resistance groups. Regardless of the type of training scheduled for that week, each session began with a 5-minute warm-up (light aerobic activity and dynamic stretching) and ended with a 5-minute cool-down (gradual reduction of intensity and static stretching). Control group: Participants in this group did not receive any exercise intervention during the 8-week study period and continued their usual daily activities. Serotonin, also known as 5-hydroxytryptamine (5-HT), is a neurotransmitter that plays a crucial role in regulating various physiological and psychological functions. Timepoint: 1 time before 8 weeks of training and 1 time after 8 weeks of training. Method of measurement: Serotonin/5-Hydroxytryptamine ELISA Kit. Dopamine is a neurotransmitter and hormone that plays several critical roles in the brain and body. It belongs to the catecholamine and phenethylamine families and is a key chemical messenger involved in many important processes. Timepoint: 1 time before 8 weeks of training and 1 time after 8 weeks of training. Method of measurement: Dopamine ELISA Kit. Interleukin-17 (IL-17) is a pro-inflammatory cytokine that plays a crucial role in the immune system, particularly in host defense and inflammatory responses. Here's a detailed overview of IL-17:Biological FunctionsImmune Response: IL-17 is primarily produced by a subset of T helper cells known as Th17 cells, but it can also be produced by other immune cells such as γδ T cells, natural killer (NK) cells, and innate lymphoid cells (ILCs). It is involved in the defense against bacterial and fungal infections by promoting the recruitment of neutrophils and macrophages to infection sites.Inflammation: IL-17 is a key mediator of inflammation. It stimulates the production of other pro-inflammatory cytokines, such as IL-6 and tumor necrosis factor-alpha (TNF-α), and promotes the release of chemokines that attract immune cells to sites of inflammation.Autoimmune Diseases: IL-17 plays a significant role in the pathogenesis of several autoimmune diseases, including psoriasis, rheumatoid arthritis, and multiple sclerosis. In these conditions, IL-17 contributes to chronic inflammation and tissue damage. Timepoint: 1 time before 8 weeks of training and 1 time after 8 weeks of training. Method of measurement: Human IL-17 Quantikine ELISA Kit (D1700). Interferon-gamma (IFN-γ) is a cytokine that plays a pivotal role in the immune system, particularly in the regulation of immune responses and inflammation. Here's a comprehensive overview of IFN-γ:Biological FunctionsImmune Activation: IFN-γ is a key activator of macrophages, enhancing their ability to phagocytose pathogens and present antigens. It also promotes the differentiation of T helper 1 (Th1) cells, which are essential for cell-mediated immunity.Antiviral and Antimicrobial Activity: IFN-γ has strong antiviral properties and is involved in the immune response against intracellular pathogens such as viruses, bacteria, and protozoa. It inhibits viral replication directly and activates immune cells to attack infected cells.Regulation of Adaptive Immunity: IFN-γ influences the adaptive immune response by promoting the differentiation of cytotoxic T cells (CD8+ T cells) and enhancing their ability to kill infected or cancerous cells. It also stimulates the production of antibodies by B cells.Inflammation and Autoimmunity: While IFN-γ is crucial for protective immunity, its dysregulation can contribute to chronic inflammation and autoimmune diseases. It is involved in the pathogenesis of conditions such as rheumatoid arthritis, multiple sclerosis, and inflammatory bowel disease. Timepoint: 1 time before 8 weeks of training and 1 time after 8 weeks of training. Method of measurement: Human IFN-gamma DuoSet ELISA DY285B-05. FOXP3 (Forkhead Box P3) is a transcription factor that is critical for the development and function of regulatory T cells (Tregs), which are essential for maintaining immune tolerance and preventing autoimmune diseases. Here’s a detailed overview of FOXP3:Biological FunctionsRegulatory T Cells (Tregs): FOXP3 is a master regulator of Tregs, a subset of T cells that suppress immune responses to maintain homeostasis and prevent excessive inflammation. Tregs play a crucial role in:Immune Tolerance: Preventing autoimmunity by suppressing autoreactive T cells that could attack the body's own tissues.Immune Response Regulation: Controlling the intensity and duration of immune responses to prevent damage to the host from chronic inflammation or overactive immune responses.Gene Expression: FOXP3 controls the expression of various genes that are essential for Treg function. These include genes involved in Treg development, stability, and suppressive functions.Suppressive Mechanisms: FOXP3+ Tregs employ multiple mechanisms to suppress immune responses, including:Secretion of Anti-inflammatory Cytokines: Such as IL-10 and TGF-β.Cytolysis: Directly killing effector T cells.Metabolic Disruption: Modifying the local environment to inhibit effector T cell function.Inhibition of Dendritic Cells: Preventing the activation of other T cells by dendritic cells. Timepoint: 1 time before 8 weeks of training and 1 time after 8 weeks of training. Method of measurement: Human Forkhead Box P3, FOXP3 ELISA Kit E0692Hu. Depression is a prevalent and serious concern in individuals with multiple sclerosis (MS), affecting up to 50% of people with the condition at some point. This high prevalence highlights the need for careful monitoring and management of depressive symptoms in MS patients. Timepoint: 1 time before 8 weeks of training and 1 time after 8 weeks of training. Method of measurement: The Beck Depression Inventory is a 21-item. Quality of life (QoL) in individuals with multiple sclerosis (MS) is influenced by a variety of factors, including physical, psychological, social, and environmental aspects. MS is a chronic and often disabling disease that can lead to significant impairments and challenges in daily life. Timepoint: 1 time before 8 weeks of training and 1 time after 8 weeks of training. Method of measurement: The multiple sclerosis impact scale (MSIS-29). University of guilan Approved 2023-12-27 Ethics Committee in Biomedical Research 5th Kilometer of Persian Gulf Highway Rasht Guilan Iran (Islamic Republic of)