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

Not Applicable

• Conditions: Hot Flashes
• Interventions: Behavioral: Aerobic excercise; Dietary Supplement: soy products

• Registration Number: NCT03434171
• Lead Sponsor: Cairo University

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-01-01
• Status Verified: 2018-02
• Study First Submitted: 2018-02-09
• Study First Submitted QC: 2018-02-09
• Last Update Submitted: 2018-02-09
• Study First Posted: 2018-02-15
• Last Update Posted: 2018-02-15
• Primary Completion: 2018-03
• Study Completion: 2018-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 50

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)

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aerobic excercise	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
Dietary modfications	soy products	women who received diet modification contains soy products (phytoestrogen) such as soy milk and soy beans every day for 12 weeks only
Aerobic excercise	soy products	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

Primary Outcome Measures

Name	Time	Method
Heat sensation changes	12 weeks after excercise	the severity of hot flashes score changes

Trial Locations

Locations (1)

Kasr Alainy medical school; 🇪🇬 Cairo, Egypt