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

Overview

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.

Full Title of Study: “Effect of Aerobic Exercises With Selected Phytoestrogen Product on Hot Flushes in Post-menopausal Women”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2018

Detailed Description

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.

Interventions

  • Behavioral: Aerobic excercise
    • 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
  • Dietary Supplement: soy products
    • diet modification contains soy products (phytoestrogen) such as soy milk and soy beans every day for 12 weeks only

Arms, Groups and Cohorts

  • Active Comparator: Aerobic excercise
    • 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
  • Active Comparator: Dietary modfications
    • women who received diet modification contains soy products (phytoestrogen) such as soy milk and soy beans every day for 12 weeks only

Clinical Trial Outcome Measures

Primary Measures

  • Heat sensation changes
    • Time Frame: 12 weeks after excercise
    • the severity of hot flashes score changes

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 47 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Cairo University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ahmed Maged, professor – Cairo University
  • Overall Official(s)
    • Ahmed Maged, MD, Principal Investigator, professor
  • Overall Contact(s)
    • Ahmed Maged, MD, +2001005227404, prof.ahmedmaged@gmail.com

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.