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IRCT20211106052979N1 IRCT 2021-12-08 Islamic Azad University The effect of aerobic training and DASH diet on insulin resistance and sex hormones in women with polycystic ovary syndrome The effect of aerobic training and DASH diet on insulin resistance and sex hormones in women with polycystic ovary syndrome 2021-10-17 anticipated 60 Complete https://irct.ir/trial/59832 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 60 participants are randomly divided into 4 groups using a table of random numbers. In the present study, the restricted randomization method was used, which will be performed in a block randomization method.The size of four blocks is equal and we will have four groups of 60 blocks (including 15 people participating in each group). Randomization tool also uses software random allocation software (Random allocation software). In addition to simple randomization, these random sequence generation software are able to generate random sequences by block generation method.For concealment, we use concealment allocation, so that the assigned group is not known before the individual is assigned.Using opaque envelopes sealed with random sequences (envelopes opaque, sealed, numbered sequentially), in which each random sequence is recorded on a card. And the cards are placed in the envelopes of the letter, respectively.In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface.Finally, the lids of the letter envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants into the study, one of the envelopes of the letter is opened in order and the assigned group of the participant is revealed. N/A Condition 1: insulin resistance. Condition 2: sex hormones. Intervention 1: Intervention group:Aerobic exercise (running) for 12 weeks and 3 sessions per week for 25-30 minutes and an intensity of 60-85% of maximum heart rate with the principle of extra load in the gym. Intervention 2: Intervention group2: use of DASH diet for 8 weeks. Intervention 3: Intervention group3: Intervention group:Aerobic exercise (running) for 12 weeks and 3 sessions per week for 25-30 minutes and an intensity of 60-85% of maximum heart rate with the principle of extra load in the gym and use of DASH diet for 8 weeks. Intervention 4: Control group: Do not receive intervention or treatment to eliminate insulin resistance or change sex hormones. 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 Given that the report of findings and the result of data analysis will be published in full in the final report and extracted articles. No need to publish data publicly
public Nniusha Tajbakhsh
Tehran - Pasdaran Crossroads - Dolat St. - Between Ekhtiarieh and Dibaji - Shahid Jafarin Abadi St. - Red Dead End Alley - Sepehr Building - Unit A51
Tehran Iran (Islamic Republic of) ۱۴۷۷۸۹۳۸۵۵ +98 21 2276 1466 niusha.tajbakhsh.nt@gmail.com Islamic Azad University scientific Niusha Tajbakhsh
Tehran - Pasdaran Crossroads - Dolat St. - Between Ekhtiarieh and Dibaji - Shahid Jafarin Abadi St. - Red Dead End Alley - Sepehr Building - Unit A51
Tehran Iran (Islamic Republic of) ۱۴۷۷۸۹۳۸۵۵ +98 21 2276 1466 niusha.tajbakhsh.nt@gmail.com Islamic Azad University Iran (Islamic Republic of) with polycystic ovary syndrome Age 20 to 40 years 20 years 40 years Female Doing regular exercise in the past year Not being healthy based on a health questionnaire E28.2 Polycystic ovarian syndrome Treatment - Other Treatment - Other Treatment - Other Other Intervention group:Aerobic exercise (running) for 12 weeks and 3 sessions per week for 25-30 minutes and an intensity of 60-85% of maximum heart rate with the principle of extra load in the gym Intervention group2: use of DASH diet for 8 weeks Intervention group3: Intervention group:Aerobic exercise (running) for 12 weeks and 3 sessions per week for 25-30 minutes and an intensity of 60-85% of maximum heart rate with the principle of extra load in the gym and use of DASH diet for 8 weeks Control group: Do not receive intervention or treatment to eliminate insulin resistance or change sex hormones Serum levels of sex hormones. Timepoint: 24 hours before the intervention and 48 hours after the last session. Method of measurement: Measurement of serum LH, TSH, FSH and serum prolactin by quantitative luminescence method. Insulin resistance. Timepoint: 24 hours before the intervention and 48 hours after the last session. Method of measurement: Insulin resistance using IR-HOMA index and based on Equation * = HOMA-IR = Fasting glucose(L / mmol)* Fasting (ml / L). Islamic Azad University Approved 2021-11-02 Islamic Azad University, Science and Research Branch Tehran - End of Shahid Sattari Highway - University Square - Shohada Hesarak Boulevard - Islamic Azad University, Science and Research Branch tehran Tehran Iran (Islamic Republic of)