Effect of aquatic based HIIT training on serum levels of BDNF, NGF,GDNF and Physical function in patients with Multiple sclerosis

To evaluate the effects of aquatic high intensity interval training on serum levels of nerve growth factor (NGF), brain derived neurotrophic factor (BDNF), glial cell line derived neurotrophic factor (GDNF), and physical performance in patients with multiple sclerosis.

A randomized, controlled, parallel-group, blinded clinical trial in 60 patients with MS; randomization will be performed using the RAND function in Microsoft Excel.

The study will be conducted at the Isfahan Multiple Sclerosis Society and an indoor swimming pool in Isfahan. Eligible participants will be randomly assigned to the intervention or control group after baseline assessment. The intervention group will participate in an 8-week aquatic high intensity interval training program, three sessions per week, while the control group will receive usual care. Because of the nature of the exercise intervention, participants and the instructor cannot be blinded. However, the outcome assessor and the data analyst will be blinded to group allocation.

Adults with relapsing remitting multiple sclerosis (RRMS), Expanded Disability Status Scale (EDSS) score 3 to 5, will be enrolled. Exclusion criteria include contraindications to exercise, pregnancy, or unwillingness to participate

The intervention group will perform 8 week aquatic high intensity interval training, three sessions weekly. The control group will receive usual care.

The primary outcomes include serum levels of NGF, BDNF, and GDNF, and physical performance assessed using standardized tests.

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.

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.

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.

Only part of the data, such as information related to the main outcome or similar details, can be shared.

Access to the course begins 6 months after the publication of the results

Researchers affiliated with academic institutions, sports trainers, physicians, and sports medicine professionals.

Meta-analytic studies

m.kargarfard@spr.ui.ac.ir

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