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IRCT20250317065108N1 IRCT 2025-04-06 Islamic Azad University "Investigating the Effects of Neuromuscular Electrical Stimulation and Core Training on Hormones and Sports Performance in Men" NMES Comparison of the Effects of Neuromuscular Electrical Stimulation and Core Training on Anabolic-Catabolic, Metabolic Hormones, and Sports Performance in Adult Man. 2025-04-05 anticipated 48 Complete https://irct.ir/trial/82645 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Other design features: 1. Simultaneous comparison of two distinct interventions: The study simultaneously compares two intervention methods (core training and NMES) and their combination with a control group. 2. Four-group design: The study employs a four-group design, including control, core training, neuromuscular electrical stimulation, and the combined group, allowing for a more detailed analysis of independent and combined effects. 3. 8-week intervention duration: The study spans an 8-week intervention period to examine the long-term effects of training and electrical stimulation. 4. Focus on anabolic and catabolic hormones: The study investigates the effects of training and NMES on anabolic and catabolic hormones, a less common focus in similar research. 5. Assessment of metabolism and physical performance: In addition to hormones, the study evaluates the impact of these interventions on physical performance and metabolic markers. 6. Body composition assessment with InBody 270: The use of the InBody 270 device for accurate body composition measurement is a unique feature of this study. 7. Utilization of advanced technology (TruSculpt Flex) for NMES: The use of the advanced TruSculpt Flex device for neuromuscular electrical, Randomization description: Participants will be randomly assigned to one of the four groups (control, core training, neuromuscular electrical stimulation, or combined training and stimulation) using block randomization with equal block sizes. The allocation sequence is not predetermined and will be generated using random number software to ensure balance across groups, Blinding description: In this study, both the outcome assessor and data analyst are blinded to group allocation. While participants and intervention administrators are aware of the assigned groups, the outcome assessor collects performance and metabolic data without knowledge of group assignments. Additionally, the data analyst processes and analyzes the data after collection and coding, ensuring blinding to group allocation. N/A Prevention. Intervention 1: The core training group will perform core stability and strength exercises for 8 weeks, 3 sessions per week. Intervention 2: Intervention group: The NMES group will receive neuromuscular electrical stimulation using the TruSculpt Flex device (2 sessions per week for 3 weeks, plus a reminder session in week 8). Intervention 3: Intervention group: The combined group will receive only NMES in the first 3 weeks and will start core training from week 4. Intervention 4: Control group: The control group will receive no intervention. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Its release schedule is not yet known.
public Khosro Jalali Dehkordi
Khorasgan University, Arghavanie St., Isfahan
Isfahan Iran (Islamic Republic of) 8183895153 +98 81 8389 5183 khosrojalali@gmail.com Islamic Azad University scientific Khosro Jalali Dehkordi
Khorasgan University, Arghavanie St.,
Isfahan Iran (Islamic Republic of) 8183895183 009831335002352 khosrojalali@gmail.com Islamic Azad University Iran (Islamic Republic of) Gender: Male Age: 35 to 55 years Good general health (No chronic metabolic, cardiovascular, or neuromuscular diseases) No prior regular core training or NMES usage in the past six months No use of hormonal drugs or metabolism-affecting supplements Ability to attend study sessions and adhere to the research protocol No regular alcohol or tobacco consumption 35 years 55 years Male Presence of metabolic, cardiovascular, or neuromuscular diseases (e.g., diabetes, heart disease, multiple sclerosis). Use of hormonal medications or supplements affecting metabolism (e.g., testosterone, steroids, insulin). History of NMES use in the past six months. Recent surgeries affecting physical activity or muscle function. Presence of implantable electronic devices (e.g., pacemakers) that may interfere with NMES. Prevention Prevention Prevention Other The core training group will perform core stability and strength exercises for 8 weeks, 3 sessions per week. Intervention group: The NMES group will receive neuromuscular electrical stimulation using the TruSculpt Flex device (2 sessions per week for 3 weeks, plus a reminder session in week 8). Intervention group: The combined group will receive only NMES in the first 3 weeks and will start core training from week 4. Control group: The control group will receive no intervention The primary outcome variables include changes in anabolic hormones (testosterone, IGF-1, growth hormone), catabolic hormones (cortisol), related metabolic markers (insulin, ALT, AST, alkaline phosphatase), and sports performance indices (muscle strength, endurance, flexibility, step length and time, symmetry, and dynamic stability in gait). These variables will be measured before and after the intervention. Timepoint: The outcome variables will be measured at two time points: before the intervention (Baseline) and after the intervention period (Post-intervention, week 8). Method of measurement: Anabolic and catabolic hormones (testosterone, IGF-1, growth hormone, cortisol, insulin): Blood samples will be collected in a fasting state and analyzed using Chemiluminescent Immunoassay (CLIA). Liver enzymes (ALT, AST) and alkaline phosphatase: Measured using biochemical enzymatic methodsŲŒ Sports performance: Muscle strength and endurance using a handheld dynamometer and standard endurance tests. Flexibility using the Sit and Reach Test. Step length, step time, symmetry, and dynamic stability in gait will be assessed using motion analysis and gait assessment systemsŲŒ Quality of Life Questionnaire (English):To assess quality of life, the Short Form Health Survey (SF-36) will be used. This questionnaire consists of 36 questions evaluating various aspects of physical and mental health. Islamic Azad University Approved 2024-12-25 Ethics Committee on Research Islamic Azad University, Isfahan Branch (Khorasgan) Arghavanie blv., Khorasgan Isfahan Isfehan Iran (Islamic Republic of)