Effect of Aerobic Exercises With Selected Phytoestrogens on Hot Flushes in Menopausal Women

Study Overview
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Brief Summary
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50 menopausal women with the diagnosis of hot flushes were randomized to 1 of 2 groups Group (A): It consists of 25 women who practiced treadmill exercise program for 30 minutes at 60% to 70% of maximum heart rate. The treatment sessions will be repeated 3 times per week for 12 weeks. Group (B): It consists of 25 women who received diet modification contains soy products (phytoestrogen) such as soy milk and soy beans every day for 12 weeks only.

Detailed Description
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50 menopausal women with the diagnosis of hot flushes were randomized to 1 of 2 groups Group (A): It consists of 25 women who practiced treadmill exercise program for 30 minutes at 60% to 70% of maximum heart rate. The treatment sessions will be repeated 3 times per week for 12 weeks. Group (B): It consists of 25 women who received diet modification contains soy products (phytoestrogen) such as soy milk and soy beans every day for 12 weeks only.

Official Title
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Effect of Aerobic Exercises With Selected Phytoestrogen Product on Hot Flushes in Post-menopausal Women

Conditions
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Hot Flashes

Intervention / Treatment
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* Behavioral: Aerobic excercise
* Dietary Supplement: soy products


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: menopausal women minimum 2 years after menopause Patients were required to have at least moderate hot flashes at time of randomization, having a score ≥ 40 in Hot Flash-Related Daily Interference Scale (HFRDIS) Exclusion Criteria: women with BMI > 30kg/m2 ingestion of any psychotropic and antidepressant medications, any Selective Estrogen Receptor Modulator medications (e.g., tamoxifen and raloxifen), any Aaromatase inhibitor medications (e.g., anastrozole, letrozole, and exemestane), leuprolide acetate, clonidine, gabapentin, pregabalin, amino acid supplements, over the counter (OTC) medications that reduced hot flashes during the last 4 weeks, ingestion of estrogen and progesterone based medications, history of suicidal thoughts, substance or alcohol dependence (with the exception of nicotine dependence) during the last 3 months and Electroconvulsive therapy (ECT) during the last 2 months.

Ages Eligible for Study
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Minimum Age: 47 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: What is the effect of aerobic exercises with diet modification on hot flushes, lutenizing hormone (L.H) and follicle stimulating hormone (F.S.H) in post-menopausal women
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Aerobic excercise<br>women who practiced treadmill exercise program for 30 minutes at 60% to 70% of maximum heart rate. The treatment sessions will be repeated 3 times per week for 12 weeks | Behavioral: Aerobic excercise<br>* practiced treadmill exercise program for 30 minutes at 60% to 70% of maximum heart rate. The treatment sessions will be repeated 3 times per week for 12 weeks<br>* Other names: trademill;Dietary Supplement: soy products<br>* diet modification contains soy products (phytoestrogen) such as soy milk and soy beans every day for 12 weeks only<br>|
| Active Comparator: Dietary modfications<br>women who received diet modification contains soy products (phytoestrogen) such as soy milk and soy beans every day for 12 weeks only | Dietary Supplement: soy products<br>* diet modification contains soy products (phytoestrogen) such as soy milk and soy beans every day for 12 weeks only<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heat sensation changes | the severity of hot flashes score changes | 12 weeks after excercise |