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IRCT20170724035269N2 IRCT 2025-05-27 Faculty of Physical Education and Sport Sciences, University of Tehran Effect of training on inflammatory markers Comparison of the effects of traditional resistance training and high-intensity functional training on toll-like receptor 4, matrix metalloproteinase 9, interleukin 4, interferon-gamma, lipid profile, muscular strength, and aerobic capacity in overweight men 2022-08-05 anticipated 39 Complete https://irct.ir/trial/83099 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization method and description: This study utilized simple randomization. Eligible participants were randomly assigned to one of the three groups: traditional resistance training (RT), high-intensity functional training (HIFT), or control (CON). Unit of randomization: The unit of randomization was at the individual level. Stratified randomization layers: No stratified randomization was used. Randomization tool: The randomization sequence was generated using a random number table and G-Power statistical software. How the random sequence was created: The random allocation sequence was created by a researcher who was not involved in the intervention, using a random number table, and the participants were assigned accordingly. Allocation concealment: To prevent selection bias, allocation codes were sealed in opaque, sealed envelopes. The intervention supervisor was blinded to group assignments until the moment of allocation, Blinding description: In this study, due to the nature of the interventions, participants were blinded to their group assignment and the primary aim of the intervention. Additionally, to minimize bias during data collection and analysis, biological sample collectors, laboratory analysts, and the data statistician were blinded to group allocations. Detailed description: Participants: Blinded to group assignment and the primary study hypothesis. Principal investigator and intervention supervisors: Aware of group allocations to manage the exercise sessions. Healthcare/sports personnel (trainers/supervisors): Not blinded. Sample collectors and laboratory staff: Blinded to group assignments. Data analyst/statistician: Analyzed coded data without knowledge of group allocation. Manuscript authors: Informed of group assignments only after the completion of data collection. Accordingly, the study is classified as a Single-blind study. N/A Condition 1: Overweight. Condition 2: Dyslipidemia. Condition 3: Low-grade systemic inflammation. Intervention 1: Intervention group 1 (High-Intensity Functional Training):Three sessions per week for 8 weeks. Each session included 4 bouts of functional exercises (squat, deadlift, shoulder press, bench press, and row) performed for 30 seconds at maximum effort using a barbell. Rest intervals were 30 seconds between exercises and 2.5 minutes between bouts. Training was supervised by an exercise physiologist at HealthLand Gym. Intervention 2: Intervention group 2 (Traditional Resistance Training):Three sessions per week for 8 weeks. Each session involved traditional resistance exercises (squat, deadlift, bench press, shoulder press, and row) using weight machines and barbells. Participants performed 3 sets of 12 repetitions at 75% of 1RM. Sessions were conducted at HealthLand Gym under supervision. Intervention 3: Control group:No intervention during the 8-week period; only participated in pre- and post-tests. Yes - There is a plan to make this available What will be shared: Data related to toll-like receptor 4 (TLR4), matrix metalloproteinase 9 (MMP-9), interferon-gamma (IFN-γ), interleukin 4 (IL-4), fasting blood sugar (FBS), lipid profile (cholesterol, HDL, LDL), and body composition of participants. Details: The individual data includes laboratory results and physical measurements (using standard devices). All data will be shared after de-identifying the participants (removal of names and identifying information). Data related to primary outcomes (inflammatory markers and lipid profile) will be available for sharing. Only personal identifiable data or confidential information will be excluded from sharing. When: Access to the data will start six months after the publication of the study results. The access period will continue for three years after the starting date. To whom: The data will be available only to researchers affiliated with academic and research institutions who submit an official request. Individuals working in industry or private companies will not have access to the data. Conditions: The data may only be used for scientific and research analyses. Commercial use or publication without prior written permission is prohibited. Applicants must submit an official request including a description of the research purpose and the intended analyses. A confidentiality agreement must be signed by the applicants. Access will be granted only after approval by the research committee. Where to obtain: Applicants must contact Dr. Fatemeh Shabkhiz exclusively to request access to the data. All requests must be formally submitted via email to: fatemeh.shabkhiz@ut.ac.ir For postal correspondence, requests should be sent to: Faculty of Physical Education and Sport Sciences, University of Tehran, North Kargar Street, above Jalal Al-Ahmad intersection, between 15th and 16th Streets, opposite the University of Tehran dormitory, Tehran, Postal Code: 1417466191. How to obtain: After submitting a formal request to Dr. Fatemeh Shabkhiz, the request will be reviewed within 10 working days. If approved by the research committee, the applicant must sign a data confidentiality agreement. After signing the agreement, the data will be provided to the applicant within a maximum of 15 working days. If the request is rejected, the reason for rejection will be formally communicated to the applicant. Comments:
public Fatemeh Shabkhiz
Faculty of Physical Education and Sport Sciences, University of Tehran, opposite the University of Tehran Dormitory, between 15th and 16th Streets, above Jalal Al-Ahmad Crossroad, North Kargar Street, Tehran
Tehran Iran (Islamic Republic of) ۱۴۱۷۴۶۶۱۹۱ +98 21 6111 8878 shabkhiz@ut.ac.ir Faculty of Physical Education and Sport Sciences, University of Tehran scientific Fatemeh Shabkhiz
Faculty of Physical Education and Sport Sciences, University of Tehran, opposite the University of Tehran Dormitory, between 15th and 16th Streets, above Jalal Al-Ahmad Crossroad, North Kargar Street, Tehran
Tehran Iran (Islamic Republic of) ۱۴۱۷۴۶۶۱۹۱ +98 21 6111 8878 shabkhiz@ut.ac.ir Faculty of Physical Education and Sport Sciences, University of Tehran Iran (Islamic Republic of) Age between 25 and 35 years. Healthy overweight men (BMI between 25 and 29.9 kg/m²). No participation in regular and organized exercise programs in the last six months. Completion of informed consent form and medical health questionnaire. 25 years 35 years Male Smoking during the past 6 months. Weight gain of more than 2 kg in the last 6 months. Participation in a weight loss program during the past 6 months. Engagement in heavy resistance training aimed at increasing muscle mass and strength during the past 6 months. Presence of chronic metabolic or endocrine diseases. Family history of early cardiac mortality. Inability to complete the exercise protocol (identified during the pilot phase). Use of any specific medication or supplement in the past six months History of cardiovascular diseases E66.3 E78.5 Overweight Hyperlipidemia, unspecified Lifestyle Lifestyle Lifestyle Intervention group 1 (High-Intensity Functional Training):Three sessions per week for 8 weeks. Each session included 4 bouts of functional exercises (squat, deadlift, shoulder press, bench press, and row) performed for 30 seconds at maximum effort using a barbell. Rest intervals were 30 seconds between exercises and 2.5 minutes between bouts. Training was supervised by an exercise physiologist at HealthLand Gym. Intervention group 2 (Traditional Resistance Training):Three sessions per week for 8 weeks. Each session involved traditional resistance exercises (squat, deadlift, bench press, shoulder press, and row) using weight machines and barbells. Participants performed 3 sets of 12 repetitions at 75% of 1RM. Sessions were conducted at HealthLand Gym under supervision. Control group:No intervention during the 8-week period; only participated in pre- and post-tests. Blood level of toll-like receptor 4 (TLR4). Timepoint: At baseline (before the start of the intervention) and After completing the 8-week intervention period. Method of measurement: Measured by enzyme-linked immunosorbent assay using a human-specific commercial kit. Blood level of matrix metalloproteinase 9 (MMP-9). Timepoint: At baseline (before the start of the intervention) and After completing the 8-week intervention period. Method of measurement: Measured by enzyme-linked immunosorbent assay using a human-specific commercial kit. Blood level of interferon-gamma (IFN-γ). Timepoint: At baseline (before the start of the intervention) and After completing the 8-week intervention period. Method of measurement: Measured by enzyme-linked immunosorbent assay using a human-specific commercial kit. Blood level of interleukin-4 (IL-4). Timepoint: At baseline (before the start of the intervention) and After completing the 8-week intervention period. Method of measurement: Measured by enzyme-linked immunosorbent assay using a human-specific commercial kit. Fasting blood sugar (FBS). Timepoint: At baseline (before the start of the intervention) and After completing the 8-week intervention period. Method of measurement: Measured by enzymatic method using an automatic biochemistry analyzer. Total cholesterol (CHOL). Timepoint: At baseline (before the start of the intervention) and After completing the 8-week intervention period. Method of measurement: Measured by enzymatic method using an automatic biochemistry analyzer. High-density lipoprotein cholesterol (HDL). Timepoint: At baseline (before the start of the intervention) and After completing the 8-week intervention period. Method of measurement: Measured by enzymatic method using an automatic biochemistry analyzer. Low-density lipoprotein cholesterol (LDL). Timepoint: At baseline (before the start of the intervention) and After completing the 8-week intervention period. Method of measurement: Measured by enzymatic method using an automatic biochemistry analyzer. Triglycerides. Timepoint: At baseline (before the start of the intervention) and After completing the 8-week intervention period. Method of measurement: Measured by enzymatic method using an automatic biochemistry analyzer. Change in body composition (body fat percentage and lean mass). Timepoint: At baseline (before the start of the intervention) and After completing the 8-week intervention period. Method of measurement: Measured by bioelectrical impedance analysis using InBody 270 device. Change in functional capacity (based on functional performance tests). Timepoint: At baseline (before the start of the intervention) and After completing the 8-week intervention period. Method of measurement: Measured by one-repetition maximum test in bench press exercise and indirect estimation of maximal oxygen consumption (VO2max) using a treadmill test. Faculty of Physical Education and Sport Sciences, University of Tehran Approved 2022-07-16 Research Ethics Committee of the Faculty of Physical Education and Sport Sciences, University of Teh Faculty of Physical Education and Sport Sciences, University of Tehran, Opposite of Tehran University Dormitory, Between 15th and 16th Streets, North Kargar Street, Above Jalal Al-Ahmad Crossroad, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)