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IRCT20170411033378N10 IRCT 2022-02-27 Hamedan University of Medical Sciences The effects of exercise on mental health of obese girls with precocious puberty The effect of exercise training and detraining on cortisol level and mental health of over weight and obese girls with precocious puberty 2022-03-21 anticipated 44 Complete https://irct.ir/trial/61990 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization is done by block method, the size of blocks is equal to 6 with two members in a ratio of 1: 1. Using the site www.sealedenvelope.com, a random sequence of 6 blocks with two members Control and Treatment is determined, then the sequence of intervention and control groups in different envelopes from number 1 to the sample size is considered. Upon arrival of each eligible volunteer, one of the envelopes is opened and its treatment group is determined. N/A Precocious puberty. Intervention 1: Intervention group: The intervention used is a combination training protocol (aerobic + resistance) for 12 weeks, 3 sessions per week and each session will be 60 minutes of aerobic + resistance training in which 30 minutes of aerobic exercise including walking, running, ball games With 55 to 65% of heart rate and 20 minutes of resistance training in the arms, legs and trunk in 2 or 3 sets of 10 to 15, which will be done through body weight or elastic bands, and at the end of each session, cool down for 10 minutes and we will return to the original state. Intervention 2: Control group:Does not receive intervention. Yes - There is a plan to make this available What will be shared: IPD briefly describe what specific participant data sets are to be shared When: starting in ŮŽJuly 2022 To whom: people working in academic institutions Conditions: people working in academic institutions Where to obtain: Efat Sadeghian via Email: sadeghianefat@gmail.com How to obtain: via Email: sadeghianefat@gmail.com Comments:
public Efat Sadeghian
Shahid Fahmideh Bulvar, Hamadan University of Medical Sciences
Hamadan Iran (Islamic Republic of) 6517838736 +98 81 3838 0150 sadeghianefat@gmail.com Hamedan University of Medical Sciences scientific Efat Sadeghian
Hamadan University of Medical Sciences, Shahid Fahmideh Blvd, Hamadan
Hamadan Iran (Islamic Republic of) 6517838736 +98 81 3838 0150 sadeghianefat@gmail.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Girls with central precocious puberty Having a BMI higher than 19 The age range of 7 to 9 years One year has passed since they were diagnosed with precocious puberty Being treated with Differlin drug Taking medication 1 ml every 28 days 7 years 9 years Female having another illness taking another medicine having a special diet (Vegetarianism, ...) being active in another sport being connected to drugs E30.1 Precocious puberty Rehabilitation Treatment - Other Intervention group: The intervention used is a combination training protocol (aerobic + resistance) for 12 weeks, 3 sessions per week and each session will be 60 minutes of aerobic + resistance training in which 30 minutes of aerobic exercise including walking, running, ball games With 55 to 65% of heart rate and 20 minutes of resistance training in the arms, legs and trunk in 2 or 3 sets of 10 to 15, which will be done through body weight or elastic bands, and at the end of each session, cool down for 10 minutes and we will return to the original state. Control group:Does not receive intervention. Cortisol. Timepoint: Baseline, 12 weeks, 16 weeks. Method of measurement: Blood sampling and use of laboratory kits Elisa method. Weight and body mass index. Timepoint: Baseline, 12 weeks, 16 weeks. Method of measurement: Digital scale, standard height meter. Anxiety. Timepoint: Baseline, 12 weeks, 16 weeks. Method of measurement: Spence Children Anxiety Scale. Depression. Timepoint: Baseline, 12 weeks, 16 weeks. Method of measurement: Self-rating Depression Scale. Aggression. Timepoint: Baseline, 12 weeks, 16 weeks. Method of measurement: Nelson Child Aggression Questionnaire. Hamadan University of Medical Sciences Approved 2022-01-26 Research Ethics Committees of Hamadan University of Medical Scieneces Shahid Fahmideh St., in front of the People's Park of Hamadan University of Medical Sciences and Health Services Hamedan Hamadan Iran (Islamic Republic of)