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IRCT20251103067863N1 IRCT 2025-12-02 The University of Tehran Can we have regional fat reduction? Regional adipose tissue changes after upper- vs lower-body combined resistance-aerobic training in men with overweight/obesity 2024-07-10 anticipated 32 Complete https://irct.ir/trial/87310 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Randomization description: The individuals randomly assigned using www.randomizer.org by an expert individual external to the study who is blinded to the participants, the training protocol, and the training group to either the upper body training group or the lower body training group, Blinding description: Both the hospital nuclear medicine specialist and the device technician will be unaware of the study group assignment at both the pre-test and post-test. The nuclear medicine specialist and the device technician will be unaware of the intervention and the details of the research work and will only be asked to perform the analyses according to the researchers' criteria. The nuclear medicine specialist will have no contact with the participants in either session, and the device technician will have only one pre-test check-up with the participants, which will be done in the presence of the researchers to ensure that no verbal communication about the study will take place. N/A over weight and obesity. Intervention 1: Intervention group: The study duration will be 10 weeks, with 3 sessions per week, for a total of 30 training sessions. The upper body group is a group whose training will be based on the upper body limbs. They will perform three consecutive sessions of upper body training, and after these three consecutive sessions, one session of lower body training, and maintain this pattern until the end, so that after completing their training, they will perform 23 sessions of upper body training and 7 sessions of lower body training. The upper body training program will include chest press, shoulder press, biceps curl, rowing, and abdominal press, which will be immediately followed by an aerobic exercise with an arm ergometer. The lower body training program will include leg press, leg extension, leg curl, leg abduction, leg adduction, and calf raise, which will be immediately followed by an aerobic exercise with a leg cycle ergometer. All resistance training will be performed in 3 sets until week 5 and in 4 sets from week 6 to the end. The repetition range in each set will be maintained between 8 and 12 repetitions, and the repetitions will continue until muscle failure. Rest between each set will be 1 to 1.5 minutes. Both aerobic exercises will be performed at an intensity of 61 to 66 percent of maximum heart rate (220-age) for those with a body fat percentage below 35 percent and at an intensity of 57 to 64 percent of maximum heart rate (220-age) for those with a body fat percentage above 35 percent. The duration of both aerobic exercises will be 20 minutes in the first week, with 1 minute added each week, so that the duration will be 29 minutes in the last week. The subjects' heart rates will be monitored during the aerobic exercise using a Polar H-10. All exercise sessions will be conducted under the supervision of the researchers. Intervention 2: Intervention group: The study duration will be 10 weeks, with 3 sessions per week, for a total of 30 training sessions. The lower body group is a group whose training will be based on the lower body limbs. They will perform three consecutive sessions of lower body training, and after these three consecutive sessions, one session of upper body training, and maintain this pattern until the end, so that after completing their training, they will perform 23 sessions of lower body training and 7 sessions of upper body training. The lower body training program will include leg press, leg extension, leg curl, leg abduction, leg adduction, and calf raise, which will be immediately followed by an aerobic exercise with a leg cycle ergometer. The upper body training program will include chest press, shoulder press, biceps curl, rowing, and abdominal press, which will be immediately followed by an aerobic exercise with an arm ergometer. All resistance training will be performed in 3 sets until week 5 and in 4 sets from week 6 to the end. The repetition range in each set will be maintained between 8 and 12 repetitions, and the repetitions will continue until muscle failure. Rest between each set will be 1 to 1.5 minutes. Both aerobic exercises will be performed at an intensity of 61 to 66 percent of maximum heart rate (220-age) for those with a body fat percentage below 35 percent and at an intensity of 57 to 64 percent of maximum heart rate (220-age) for those with a body fat percentage above 35 percent. The duration of both aerobic exercises will be 20 minutes in the first week, with 1 minute added each week, so that the duration will be 29 minutes in the last week. The subjects' heart rates will be monitored during the aerobic exercise using a Polar H-10. All exercise sessions will be conducted under the supervision of the researchers. Yes - There is a plan to make this available What will be shared: anonymized individual participant data (IPD) will be shared upon reasonable request. Anonymized datasets including demographic information, primary and secondary outcomes, and variables used in statistical analyses will be shared When: Data will be available approximately 6 months after completion of the main analyses and publication of the results, and will remain available for 5 years thereafter. To whom: Data will be shared with academic researchers, research institutions, or other individuals with valid scientific purposes. Conditions: Data may be used for secondary analyses, meta-analyses, or related research within the same scientific field. Where to obtain: To receive the data, contact the researcher responsible, Saman Negahdar, via email at samanneghdar@gmai.com. How to obtain: Interested researchers should submit a formal request to the corresponding investigator. After receiving the request, the research committee will review it, and if approved, a Data Use Agreement will be sent to the applicant. Upon signing this agreement by both parties, anonymized data will be shared in Excel or SPSS format via email or secure cloud storage. Comments:
public Saman Negahdar
Morvarid Alley 6, Lazur St., Baharan Town 2/19, Sanandaj
Sanandaj Iran (Islamic Republic of) 6617874784 +98 87 3371 0120 samanneghdar@gmail.com The University of Tehran scientific Saman Negahdar
Morvarid Alley 6, Lazur St., Baharan Town 2/19, Sanandaj
Sanandaj Iran (Islamic Republic of) 6617874784 +98 87 3371 0120 samanneghdar@gmail.com The University of Tehran Iran (Islamic Republic of) male individuals aged 20 to 45 years a body mass index (BMI) exceeding 25 kg/m² individuals who are inactive or have not engaged in regular physical exercise for a minimum of six months 20 years 45 years Male history of metabolic, cardiac, or musculoskeletal diseases use of medical medications, sports supplements, or anabolic steroids Being a smoker regular alcohol consumption E66 Overweight and obesity Treatment - Other Treatment - Other Intervention group: The study duration will be 10 weeks, with 3 sessions per week, for a total of 30 training sessions. The upper body group is a group whose training will be based on the upper body limbs. They will perform three consecutive sessions of upper body training, and after these three consecutive sessions, one session of lower body training, and maintain this pattern until the end, so that after completing their training, they will perform 23 sessions of upper body training and 7 sessions of lower body training. The upper body training program will include chest press, shoulder press, biceps curl, rowing, and abdominal press, which will be immediately followed by an aerobic exercise with an arm ergometer. The lower body training program will include leg press, leg extension, leg curl, leg abduction, leg adduction, and calf raise, which will be immediately followed by an aerobic exercise with a leg cycle ergometer. All resistance training will be performed in 3 sets until week 5 and in 4 sets from week 6 to the end. The repetition range in each set will be maintained between 8 and 12 repetitions, and the repetitions will continue until muscle failure. Rest between each set will be 1 to 1.5 minutes. Both aerobic exercises will be performed at an intensity of 61 to 66 percent of maximum heart rate (220-age) for those with a body fat percentage below 35 percent and at an intensity of 57 to 64 percent of maximum heart rate (220-age) for those with a body fat percentage above 35 percent. The duration of both aerobic exercises will be 20 minutes in the first week, with 1 minute added each week, so that the duration will be 29 minutes in the last week. The subjects' heart rates will be monitored during the aerobic exercise using a Polar H-10. All exercise sessions will be conducted under the supervision of the researchers. Intervention group: The study duration will be 10 weeks, with 3 sessions per week, for a total of 30 training sessions. The lower body group is a group whose training will be based on the lower body limbs. They will perform three consecutive sessions of lower body training, and after these three consecutive sessions, one session of upper body training, and maintain this pattern until the end, so that after completing their training, they will perform 23 sessions of lower body training and 7 sessions of upper body training. The lower body training program will include leg press, leg extension, leg curl, leg abduction, leg adduction, and calf raise, which will be immediately followed by an aerobic exercise with a leg cycle ergometer. The upper body training program will include chest press, shoulder press, biceps curl, rowing, and abdominal press, which will be immediately followed by an aerobic exercise with an arm ergometer. All resistance training will be performed in 3 sets until week 5 and in 4 sets from week 6 to the end. The repetition range in each set will be maintained between 8 and 12 repetitions, and the repetitions will continue until muscle failure. Rest between each set will be 1 to 1.5 minutes. Both aerobic exercises will be performed at an intensity of 61 to 66 percent of maximum heart rate (220-age) for those with a body fat percentage below 35 percent and at an intensity of 57 to 64 percent of maximum heart rate (220-age) for those with a body fat percentage above 35 percent. The duration of both aerobic exercises will be 20 minutes in the first week, with 1 minute added each week, so that the duration will be 29 minutes in the last week. The subjects' heart rates will be monitored during the aerobic exercise using a Polar H-10. All exercise sessions will be conducted under the supervision of the researchers. Body weight. Timepoint: 48 to 72 hours before the first training session and 48 to 72 hours after the last training session. Method of measurement: Participants will be admitted to Kowsar Hospital in Sanandaj, Iran, between 7:00 and 9:00 a.m. They will be instructed to refrain from any physical activity for a duration of 24 to 48 hours prior to the pre-test and to undergo an overnight fasting period of at least 12 hours. Their weight will be measured using a digital scale with an accuracy of 0.01 kg, and participants will be requested to void their bladders prior to measurement. Body mass index. Timepoint: 48 to 72 hours before the first training session and 48 to 72 hours after the last training session. Method of measurement: Participants will be admitted to Kowsar Hospital in Sanandaj, Iran, between 7:00 and 9:00 a.m. They will be instructed to refrain from any physical activity for a duration of 24 to 48 hours prior to the pre-test and to undergo an overnight fasting period of at least 12 hours. Height will be measured using a wall-mounted height gauge with an accuracy of 0.01 cm. The measurement conditions will be standardized: subjects will be attired in medical gowns, with bare feet, standing on a completely flat surface. Participants will be instructed to position the backs of their heels, buttocks, and the area between their shoulder blades against the wall while maintaining a forward gaze. Researchers will verify the alignment of these three anatomical points along with the positioning of the head before recording height measurements from the scalp. Body mass index will be calculated using the formula: Body mass index = body weight (kg) / height squared (m²). Upper body fat mass. Timepoint: 48 to 72 hours before the first training session and 48 to 72 hours after the last training session. Method of measurement: Participants will be admitted to Kowsar Hospital in Sanandaj, Iran, between 7:00 and 9:00 a.m. They will be instructed to refrain from any physical activity for a duration of 24 to 48 hours prior to the pre-test and to undergo an overnight fasting period of at least 12 hours. They will also be asked to wear a hospital gown and empty their bladder before the analysis. Subjects will be asked to lie on the DEXA machine, and their body position will be checked by the DEXA technician. The researchers will be present to ensure that the DEXA technician is blinded and to prevent any exchange of information between the subjects and the technician. After the subjects' body position has been checked, the DEXA analysis will begin. The area between a horizontal line traversing the superior aspect of the acromion and a horizontal line passing through the apex of the iliac crest will be considered the upper body. A vertical line will also be drawn from the outermost point of the pelvic bone to the apex of the axilla on both sides, with all areas outside this line classified as hands and their data calculated as upper body. All scans will be performed by STRATOS DR (v4.0.13.1 19-06-2020). Lower body fat mass. Timepoint: 48 to 72 hours before the first training session and 48 to 72 hours after the last training session. Method of measurement: Participants will be admitted to Kowsar Hospital in Sanandaj, Iran, between 7:00 and 9:00 a.m. They will be instructed to refrain from any physical activity for a duration of 24 to 48 hours prior to the pre-test and to undergo an overnight fasting period of at least 12 hours. They will also be asked to wear a hospital gown and empty their bladder before the analysis. Subjects will be asked to lie on the DEXA machine, and their body position will be checked by the DEXA technician. The researchers will be present to ensure that the DEXA technician is blinded and to prevent any exchange of information between the subjects and the technician. After the subjects' body position has been checked, the DEXA analysis will begin. The area between the horizontal line passing through the apex of iliac crest to the sole of the foot will considered as the lower body. All scans will be performed by STRATOS DR (v4.0.13.1 19-06-2020). Whole body fat mass. Timepoint: 48 to 72 hours before the first training session and 48 to 72 hours after the last training session. Method of measurement: Participants will be admitted to Kowsar Hospital in Sanandaj, Iran, between 7:00 and 9:00 a.m. They will be instructed to refrain from any physical activity for a duration of 24 to 48 hours prior to the pre-test and to undergo an overnight fasting period of at least 12 hours. They will also be asked to wear a hospital gown and empty their bladder before the analysis. Subjects will be asked to lie on the DEXA machine, and their body position will be checked by the DEXA technician. The researchers will be present to ensure that the DEXA technician is blinded and to prevent any exchange of information between the subjects and the technician. After the subjects' body position has been checked, the DEXA analysis will begin. The whole body fat mass will defined as the sum of the upper and lower body fat masses. All scans will be performed by STRATOS DR (v4.0.13.1 19-06-2020). Upper body lean mass. Timepoint: 48 to 72 hours before the first training session and 48 to 72 hours after the last training session. Method of measurement: Participants will be admitted to Kowsar Hospital in Sanandaj, Iran, between 7:00 and 9:00 a.m. They will be instructed to refrain from any physical activity for a duration of 24 to 48 hours prior to the pre-test and to undergo an overnight fasting period of at least 12 hours. They will also be asked to wear a hospital gown and empty their bladder before the analysis. Subjects will be asked to lie on the DEXA machine, and their body position will be checked by the DEXA technician. The researchers will be present to ensure that the DEXA technician is blinded and to prevent any exchange of information between the subjects and the technician. After the subjects' body position has been checked, the DEXA analysis will begin. The area between a horizontal line traversing the superior aspect of the acromion and a horizontal line passing through the apex of the iliac crest will be considered the upper body. A vertical line will also be drawn from the outermost point of the pelvic bone to the apex of the axilla on both sides, with all areas outside this line classified as hands and their data calculated as upper body. All scans will be performed by STRATOS DR (v4.0.13.1 19-06-2020). Lower body lean mass. Timepoint: 48 to 72 hours before the first training session and 48 to 72 hours after the last training session. Method of measurement: Participants will be admitted to Kowsar Hospital in Sanandaj, Iran, between 7:00 and 9:00 a.m. They will be instructed to refrain from any physical activity for a duration of 24 to 48 hours prior to the pre-test and to undergo an overnight fasting period of at least 12 hours. They will also be asked to wear a hospital gown and empty their bladder before the analysis. Subjects will be asked to lie on the DEXA machine, and their body position will be checked by the DEXA technician. The researchers will be present to ensure that the DEXA technician is blinded and to prevent any exchange of information between the subjects and the technician. After the subjects' body position has been checked, the DEXA analysis will begin. The area between the horizontal line passing through the apex of iliac crest to the sole of the foot will considered as the lower body. All scans will be performed by STRATOS DR (v4.0.13.1 19-06-2020). Whole body lean mass. Timepoint: 48 to 72 hours before the first training session and 48 to 72 hours after the last training session. Method of measurement: Participants will be admitted to Kowsar Hospital in Sanandaj, Iran, between 7:00 and 9:00 a.m. They will be instructed to refrain from any physical activity for a duration of 24 to 48 hours prior to the pre-test and to undergo an overnight fasting period of at least 12 hours. They will also be asked to wear a hospital gown and empty their bladder before the analysis. Subjects will be asked to lie on the DEXA machine, and their body position will be checked by the DEXA technician. The researchers will be present to ensure that the DEXA technician is blinded and to prevent any exchange of information between the subjects and the technician. After the subjects' body position has been checked, the DEXA analysis will begin. The whole body lean mass will defined as the sum of the upper and lower body lean masses. All scans will be performed by STRATOS DR (v4.0.13.1 19-06-2020). The University of Tehran Approved 2024-05-11 Research Ethics Committee of the University of Tehran, Faculty of Sport Sciences and Health Tehran - North Kargar Street - Above Jalal Al-Ahmad Intersection - Between 15th and 16th Streets - Opposite Tehran University Alley Tehran Tehran Iran (Islamic Republic of)