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

NCT03434171 | Unknown DMC

• 1 other identifier: 26
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Hot Flashes

Outcome Measures

Primary Outcomes (1)

• Heat sensation changes

  the severity of hot flashes score changes

  12 weeks after excercise

Study Arms (2)

Aerobic excercise

ACTIVE COMPARATOR

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; Dietary Supplement: soy products

Dietary modfications

ACTIVE COMPARATOR

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

Interventions

Aerobic excercise BEHAVIORAL

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

Also known as: trademill

Aerobic excercise

soy products DIETARY_SUPPLEMENT

diet modification contains soy products (phytoestrogen) such as soy milk and soy beans every day for 12 weeks only

Aerobic excercise; Dietary modfications

Eligibility Criteria

• Age: 47 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alainy medical school

Cairo, 12151, Egypt

RECRUITING

MeSH Terms

Conditions

Hot Flashes

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ahmed Maged, MD

  professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Maged, MD

CONTACT

+2001005227404; prof.ahmedmaged@gmail.com

Amr Abassy, MD

CONTACT

women.health2012@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: 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

Study Record Dates

• First Submitted: February 9, 2018
• First Posted: February 15, 2018
• Study Start: January 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: February 15, 2018

Record last verified: 2018-02

Locations

EG (1)