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

Hot Flashes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03434171
• Other study ID #: 26
• Status: Recruiting
• Phase: N/A
• First received: February 9, 2018
• Last updated: February 9, 2018
• Start date: January 1, 2016
• Est. completion date: March 2018

Study information

• Verified date: February 2018
• Source: Cairo University
• Contact: Ahmed Maged, MD
• Phone: +2001005227404
• Email: prof.ahmedmaged[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 47 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hot Flashes

Intervention

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

Locations

Country	Name	City	State
Egypt	Kasr Alainy medical school	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heat sensation changes	the severity of hot flashes score changes	12 weeks after excercise