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

NCT ID: NCT03434171

Last Updated: 2018-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-01

Study Completion Date

2018-03-31

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.

Conditions

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Hot Flashes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Aerobic excercise

Intervention Type 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

soy products

Intervention Type DIETARY_SUPPLEMENT

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

Dietary modfications

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

Group Type ACTIVE_COMPARATOR

soy products

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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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

Intervention Type BEHAVIORAL

soy products

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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trademill

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.
Minimum Eligible Age

47 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Maged

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed Maged, MD

Role: PRINCIPAL_INVESTIGATOR

professor

Locations

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Kasr Alainy medical school

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Ahmed Maged, MD

Role: CONTACT

+2001005227404

Amr Abassy, MD

Role: CONTACT

Facility Contacts

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Ahmed Maged, MD

Role: primary

01005227404

Other Identifiers

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26

Identifier Type: -

Identifier Source: org_study_id

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