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IRCT20220821055765N1 IRCT 2022-09-23 Islamic Azad University Rasht Branch The Effect of Concurrent Aerobic-ResistanceTraining Period as Well as with Tribulus supplementation on cellular enzymes, inflammatory and metabolic markers, Brain-derived neurotrophic factor, memory and sexual function of overweight postmenopausal women The Effect of Concurrent Aerobic-ResistanceTraining Period as Well as with Tribulus supplementation on cellular enzymes, inflammatory and metabolic markers,Brain-derived neurotrophic factor, memory and sexual function of overweight postmenopausal women 2022-09-15 anticipated 90 Complete https://irct.ir/trial/65419 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization method, simple, lottery: In this method, 60 menopausal women with menopausal complications will be selected by available sampling method. through lottery (names of the participants are written on paper and will be divided into 4 groups (3 intervention groups and 1 control group) through random lottery). 3 Menopause with excess weight. Intervention 1: Intervention group: First, high-intensity combined exercise for 10 weeks, 3 days a week and for 60 minutes each day, which included 5 minutes of warm-up, 20 minutes of aerobic exercise program, 30 minutes of resistance exercises with resistance bands. Bodybuilding and 5 minutes of cooling were done. During this period, all participants were urged to maintain their usual activities and refrain from other physical exercises. Intervention 2: Intervention group: Second, consumption of Tribulus supplement: Tribulus supplement with Iranian name Kharkhasek and brand name Tribulus 500 mg, manufactured by Dayan Hat Company, made in Iran. Also, this supplement has phytopharmacology approval from India and China. Participants took 500 mg capsules twice a day (after breakfast and dinner) for 70 days. Intervention 3: Intervention group: 3rd, simultaneous high-intensity combined exercise with Tribulus supplement: simultaneous high-intensity combined exercise for 10 weeks, 3 days a week and for 60 minutes every day, where bodybuilding resistance band was performed and 500 capsules Tribulus supplements were taken twice a day. Intervention 4: Control group: The inactive control group, although they were physically active, did not participate in any resistance training or other regular training for a year before the start of the study. The passive control group continued their normal life without any changes and at the end of the study, they were compared with three other experimental groups. 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 Roya Seighali
No. 110, Emdad Alley, Namaz Blvd., Golsar Ave.
Rasht Iran (Islamic Republic of) 4168675995 +98 13 3376 2536 roya.seighaly@gmail.com Islamic Azad University Rasht Branch scientific Roya Seighali
No. 110, Emdad Alley, Namaz Blvd., Golsar Ave.
Rasht Iran (Islamic Republic of) 4168675995 +98 13 3376 2536 roya.seighaly@gmail.com Islamic Azad University Rasht Branch Iran (Islamic Republic of) All participants have overweight. For all participants, one year passed from their last menstrual period (they are all menopause). Non of participants had hormone treatment. All participants reported difficulties from menopause. All participants had less than 1 hour exercise per week for the last year. 55 years 65 years Female Participants who are smokers (they smoked for 6 months before starting the research). Participants with uncontrolled cardiovascular, renal, pulmonary, thyroid, and blood pressure diseases. Participants with limited mobility and musculoskeletal injury. N95.1 Menopausal and female climacteric states Lifestyle Lifestyle Lifestyle Lifestyle Intervention group: First, high-intensity combined exercise for 10 weeks, 3 days a week and for 60 minutes each day, which included 5 minutes of warm-up, 20 minutes of aerobic exercise program, 30 minutes of resistance exercises with resistance bands. Bodybuilding and 5 minutes of cooling were done. During this period, all participants were urged to maintain their usual activities and refrain from other physical exercises. Intervention group: Second, consumption of Tribulus supplement: Tribulus supplement with Iranian name Kharkhasek and brand name Tribulus 500 mg, manufactured by Dayan Hat Company, made in Iran. Also, this supplement has phytopharmacology approval from India and China. Participants took 500 mg capsules twice a day (after breakfast and dinner) for 70 days. Intervention group: 3rd, simultaneous high-intensity combined exercise with Tribulus supplement: simultaneous high-intensity combined exercise for 10 weeks, 3 days a week and for 60 minutes every day, where bodybuilding resistance band was performed and 500 capsules Tribulus supplements were taken twice a day. Control group: The inactive control group, although they were physically active, did not participate in any resistance training or other regular training for a year before the start of the study. The passive control group continued their normal life without any changes and at the end of the study, they were compared with three other experimental groups. The role of brain-derived neurotrophic factor in the flexibility of the central nervous system, memory and its relationship with both strength and aerobic sports activities. Timepoint: Neurotrophic factor was measured at the beginning of the study, 70 days after the intervention and 3 months after the end of the study. Method of measurement: Measurement of neurotrophic factor with ELISA laboratory kit. Estradiol hormone changes. Timepoint: Estradiol measurement was done at the beginning of the study, 70 days after the intervention and 3 months after the end of the study. Method of measurement: Estradiol measurement by enzyme method with ELISA laboratory kit. Testosterone hormone changes in menopausal women. Timepoint: Testosterone was measured at the beginning of the study and 70 days after the intervention. Method of measurement: Testosterone measurement by enzyme method with ELISA laboratory kit. Prospective and retrospective memory scores by Crawford et al based on a five-point Likert scale. Timepoint: Memory measurement was done at the beginning of the study, 70 days after the intervention and 3 months after the end of the study. Method of measurement: Measuring memory with Crawford et al.'s questionnaire based on a five-point Likert scale. Cortisol assessment after menopause. Timepoint: Cortisol was measured at the beginning of the study and 70 days after the intervention (at 8 am). Method of measurement: Cortisol measurement with ELISA laboratory kit. Anthropometric index in postmenopausal women. Timepoint: Anthropometric measurement was done at the beginning of the study, 70 days after the intervention and 3 months after the end of the study. Method of measurement: Anthropometric measurement by caliper with Jackson-Pollack three point method and using body density formula and Satiety equation. Changes in sexual self-efficacy in menopause. Timepoint: Sexual self-efficacy was measured at the beginning of the study, 70 days after the intervention and 3 months after the end of the study. Method of measurement: Measuring sexual efficiency with the Schwartz sexual questionnaire. Plasma inflammatory index in postmenopausal women. Timepoint: The inflammatory index was measured at the beginning of the study and 70 days after the intervention. Method of measurement: Measurement of plasma inflammatory index by immunoturbidometric method. Selected indicators of cell damage in postmenopausal women. Timepoint: Variables were measured at the beginning of the study and 70 days after the intervention. Method of measurement: Measurement of the selected index of cell damage with the German standardized enzymatic method and autoanalyzer. Islamic Azad University Rasht Branch Approved 2022-08-13 Ethics Committee of Islamic Azad University, Rasht Branch Lakan Blvd. Rasht Guilan Iran (Islamic Republic of)