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IRCT20230129057269N1 IRCT 2023-02-21 Tehran University of Medical Sciences Comparing the effectiveness of HIIT and moderate intensity continues training on weight loss Comparing the effectiveness of home-based high-intensity interval training and moderate intensity continues training on weight loss in overweight and obese adults 2023-02-14 anticipated 72 Complete https://irct.ir/trial/68328 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The participants are randomly divided to one of the 3 groups of High Intensity Interval Training (HIIT) (receiving a high intensity interval exercise program + nutrition counseling), Moderate Intensity Continues Training (MICT) (receiving a continuous exercise program + nutrition counseling) or only nutrition counseling with a 1:1:1 ratio.The randomization method is based by computer generated random numbers. This will be done by someone outside the research team, Blinding description: Due to the nature of the intervention, it is not possible to blind the participants, but the person responsible for the evaluations and the statistical analyst will not be aware of the assignment of people to the groups. N/A Overweight and obesity. Intervention 1: First intervention group: Exercising 3 days a week, performing intermittent aerobic activities with high intensity 85-95% of Heart Rate Maximum (HRMax), equivalent to RPE 7-9 on the Borg scale, in the form of 10-12 repetitions of bouts of 30-90 seconds with 30-60 seconds of rest. Each bout is performed in one station and a combination of running, running in place, going up and down the stairs, walking high knees, jumping jack, jumping rope, etc.Before performing workouts, 5 minutes of warm-up (W/U) including brisk walking, flexibility exercises, and 5 minutes of cooling down (C/D) will be performed at the end of the training session. Intervention 2: Second intervention group: Exercising 3 days a week, doing aerobic activity with moderate intensity of 85-70% of Heart Rate Maximum (HRMax), equivalent to RPE 4-6 on the Borg scale, doing continuous exercises for 30 minutes, the type of activity can be one or a combination of fast walking , treadmill, bicycle (if there are available home equipments). Before performing workouts, 5 minutes of warm-up (W/U) including brisk walking, flexibility exercises, and 5 minutes of cooling down (C/D) will be performed at the end of the training session. 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 There is no further information
public Seyedayin Hosseini
No.7, Al-e Ahmad Highway , Sports and Exercise Medicine Research Center,Tehran, Iran
Tehran Iran (Islamic Republic of) 1411734141 +98 21 8833 0032 ayin.meimand@gmail.com Tehran University of Medical Sciences scientific Behnaz Mahdaviani
No.7, Al-e Ahmad Highway , Sports and Exercise Medicine Research Center,Tehran, Iran
Tehran Iran (Islamic Republic of) 1411734141 +98 21 8833 0032 behnazmahdaviani@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Adults between the ages of 18 to 50 BMI between 25 to 35 No participation in a weight loss program in the past year Lack of regular participation in physical activity in the last 6 months (via SF-IPAQ questionnaire) Absence of pregnancy and breastfeeding Not taking drugs affecting metabolism Absence of musculoskeletal diseases that result in limitations of performing workouts Absence of cardiovascular, respiratory, neurological, psychiatric (via HADS questionnaire), endocrine diseases Being affected by any other weight loss intervention (including receiving nutritional or exercise regimens further than the assigned treatment, receiving supplements and drugs that affect metabolism, using other alternative methods) during the study will lead to exclusion from the study. 18 years 50 years Both E66 Overweight and obesity Lifestyle Lifestyle First intervention group: Exercising 3 days a week, performing intermittent aerobic activities with high intensity 85-95% of Heart Rate Maximum (HRMax), equivalent to RPE 7-9 on the Borg scale, in the form of 10-12 repetitions of bouts of 30-90 seconds with 30-60 seconds of rest. Each bout is performed in one station and a combination of running, running in place, going up and down the stairs, walking high knees, jumping jack, jumping rope, etc.Before performing workouts, 5 minutes of warm-up (W/U) including brisk walking, flexibility exercises, and 5 minutes of cooling down (C/D) will be performed at the end of the training session. Second intervention group: Exercising 3 days a week, doing aerobic activity with moderate intensity of 85-70% of Heart Rate Maximum (HRMax), equivalent to RPE 4-6 on the Borg scale, doing continuous exercises for 30 minutes, the type of activity can be one or a combination of fast walking , treadmill, bicycle (if there are available home equipments). Before performing workouts, 5 minutes of warm-up (W/U) including brisk walking, flexibility exercises, and 5 minutes of cooling down (C/D) will be performed at the end of the training session. Weight. Timepoint: The start of the study (before the intervention) and the 12th week. Method of measurement: Using the same standard method and scale. Maximal O2 uptake. Timepoint: The start of the study (before the intervention) and the 12th we. Method of measurement: The step test will be performed using the Queen's college method, and the maximal O2 uptake will be estimated via the formula. Adherence rate. Timepoint: Weeks 4,8 and 12. Method of measurement: The percentage of the number of training sessions that have been performed completely to the total sessions. Drop out rate. Timepoint: Weeks 4,8 and 12. Method of measurement: The number of people who dropped out during the study. Adverse events. Timepoint: Weeks 4,8 and 12. Method of measurement: Any complication related to the intervention that occur during the study is recorded in the exercise log book. Anthropometric findings(waist circumference, hip circumference, waist/hip circumference ratio). Timepoint: At the start of the study (before the intervention) and the 12th week. Method of measurement: Using the same standard method and metric tool. Blood pressure. Timepoint: At the start of the study (before the intervention) and the 12th week. Method of measurement: In a sitting position and after 5 minutes of rest, with the same sphygmomanometer, the average of two measurements will be recorded. If there is a difference of more than 5mmHg in the measurements, whether systolic or diastolic pressure, the measurement will be repeated for the third time. . Lipid profile including TG, LDL and HDL. Timepoint: At the start of the study (before the intervention) and the 12th week. Method of measurement: Examined at the same laboratory for biochemical evaluations after 12hours of fasting. Factors related to glucose metabolism including FBS and HOMA-IR. Timepoint: At the start of the study (before the intervention) and the 12th week. Method of measurement: Examined at the same laboratory for biochemical evaluations after 12hours of fasting. Body composition (body fat percentage). Timepoint: At the start of the study (before the intervention) and the 12th week. Method of measurement: The percentage of body fat and other components will be determined by the Bioelectrical Impedance Analysis method using the relevant device. Tehran University of Medical Sciences Approved 2023-01-16 Research Ethics Committees of Neuroscience Institute No.7, Al-e Ahmad Highway , Sports and Exercise Medicine Research Center,Tehran, Iran Tehran Tehran Iran (Islamic Republic of)