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IRCT20260127068676N1 IRCT 2026-07-26 Vice President for Research and Technology Effect of Hydrotherapy on Multiple Sclerosis Effect of aquatic based HIIT training on serum levels of BDNF, NGF,GDNF and Physical function in patients with Multiple sclerosis 2026-07-23 anticipated 60 Complete https://irct.ir/trial/88790 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Initially, the statistical population consisted of patients with RRMS and an EDSS score between 3 and 5 from the city of Isfahan. After applying the inclusion and exclusion criteria, 45 individuals were selected purposively and voluntarily and were randomly allocated, using Random Allocation software, into two groups: a water-based high-intensity interval training group (25 individuals) and a control group (20 individuals). This type of randomization was simple randomization, Blinding description: This research was a randomized controlled trial parallel two - arm design, investigating the effects of an eight-week water-based high-intensity interval training program on neurotrophic factors and physical performance in patients with Relapsing-Remitting Multiple Sclerosis (RRMS). To maximize the internal validity of the findings and prevent bias, the study implemented a rigorous blinding protocol at the levels of assessment and data analysis. Although blinding the participants or exercise trainers was not feasible due to the nature of the physical intervention, the research protocol was specifically designed to ensure that the assessors of physical performance, the laboratory technicians measuring the biochemical variables, and the statistical analysts remained completely unaware (blinded) of the participants' allocation to the intervention or control groups. This was achieved by coding all samples, separating the data collection process from group allocation knowledge, and providing the coded data to an independent statistician. N/A Multiple Sclerosis (MS). Intervention 1: "The intervention group:" will participate in an 8-week aquatic high-intensity interval training (aHIIT) program, consisting of three sessions per week. Each session will include a 15-minute warm-up, 10 intervals of 30-second high-intensity exercise at 85–95% of maximum heart rate (HRmax) separated by 1-minute active recovery, and a 10-minute cool-down. Exercise intensity will be monitored using heart rate and the Borg Rating of Perceived Exertion (RPE), and all sessions will be supervised by a qualified instructor. Intervention 2: "Control group:" Participants in the control group will be placed on a wait-list and will receive their usual care during the 8-week study period. They will not receive the water-based high-intensity interval training program and will be asked to maintain their usual level of physical activity. After completion of the study, the exercise program will be offered to participants in the control group. No - There is not a plan to make this available Justification or reason for not sharing IPD is Individual participant data will not be shared to protect participant confidentiality and in accordance with ethical requirements and data protection regulations. Study results will be reported only in aggregated form without identifying individual participants.
public Roya Karimi Alavijeh
University of Isfahan, Faculty of Sport Sciences, Hezarjarib Street, Azadi Square
Isfahan Iran (Islamic Republic of) 8174673441 00983166751 RoyakarimiAlavijeh@spr.ui.ac.ir University of Isfahan scientific Mehdi kargarfard
University of Isfahan, Faculty of Sport Sciences, Hezarjarib Street, Azadi Square
Isfahan Iran (Islamic Republic of) ۸۱۷۴۶۷۳۴۴۱ +98 31 3668 7572 m.kargarfard@spr.ui.ac.ir University of Isfahan Iran (Islamic Republic of) Diagnosed with RR-type (relapsing-remitting) multiple sclerosis by MS (multiple sclerosis) expert neurologists, and Expanded Disability Status Scale (EDSS) cit 10 Score of 3-5 participated in this study. Being female Having a body mass index (BMI) between 25 and 29.9 kg/m² Not participating in regular physical activity programs in the past 6 months Having informed consent to participate in the research 28 years 48 years Female Suffering from serious acute or chronic diseases, including uncompensated heart failure, angina pectoris, myocardial infarction, kidney diseases, uncontrolled hypertension, severe arthritis, active respiratory diseases, COVID-19, acute orthopedic problems, or severe chronic joint pain primary progressive MS Irregular participation in the exercise program and absence from more than three consecutive sessions or five intermittent sessions Failure to attend measurement sessions for dependent variables at the beginning and end of the intervention Participation in any systematic physical activity program outside the research protocol during the study period Experiencing a relapse during the study acute or chronic physical or psychological disorders Rehabilitation Behavior "The intervention group:" will participate in an 8-week aquatic high-intensity interval training (aHIIT) program, consisting of three sessions per week. Each session will include a 15-minute warm-up, 10 intervals of 30-second high-intensity exercise at 85–95% of maximum heart rate (HRmax) separated by 1-minute active recovery, and a 10-minute cool-down. Exercise intensity will be monitored using heart rate and the Borg Rating of Perceived Exertion (RPE), and all sessions will be supervised by a qualified instructor. "Control group:" Participants in the control group will be placed on a wait-list and will receive their usual care during the 8-week study period. They will not receive the water-based high-intensity interval training program and will be asked to maintain their usual level of physical activity. After completion of the study, the exercise program will be offered to participants in the control group. Brain Drive Neurotrophic Factor (BDNF). Timepoint: At Baseline and After 8 Weeks of Intervention. Method of measurement: Blood Sample. Nerve Growth Factor (NGF). Timepoint: At Baseline and After 8 Weeks of Intervention. Method of measurement: Blood Sample. Physical Performance. Timepoint: At Baseline and After 8 Weeks of Intervention. Method of measurement: Physical performance will be assessed using the Timed Up and Go Test (TUGT), the 6-Minute Walk Test (6MWT), the 10-Meter Walk Test (10MWT), the 30-Second Sit-to-Stand Test (30STS), and the Berg Balance Scale (BBS). Soluble Neural Cell Adhesion Molecule (sNCAM). Timepoint: At Baseline and After 8 Weeks of Intervention. Method of measurement: Blood Sample. Glial cell line-derived neurotrophic factor (GDNF). Timepoint: At Baseline and After 8 Weeks of Intervention. Method of measurement: Blood Sample. Multiple Sclerosis Quality of Life-54 (MSQOL-54). Timepoint: At Baseline and After 8 Weeks of Intervention. Method of measurement: Quality of life will be assessed using the Multiple Sclerosis Quality of Life-54 (MSQOL-54) questionnaire. Cognitive Function. Timepoint: At Baseline and After 8 Weeks of Intervention. Method of measurement: Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA) and the Mini-Mental State Examination (MMSE). Expanded Disability Status Scale (EDSS). Timepoint: At Baseline and After 8 Weeks of Intervention. Method of measurement: Disability status will be assessed using the Expanded Disability Status Scale (EDSS). Vice President for Research and Technology Approved 2025-08-16 Research Ethics Committee of the University of Isfahan Azadi Square, Hezar Jarib Street, University of Isfahan Isfahan Isfehan Iran (Islamic Republic of)