Effect of Aerobic Exercises With Selected Phytoestrogens... | NCT03434171

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

NCT03434171

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Feb 15, 2018Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Hot Flashes

Interventions

Aerobic excercise
soy products

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2016Actual

Primary Completion Date

Mar 2018Estimated

Completion Date

Mar 2018Estimated

First Submitted Date

Feb 9, 2018

First Submission Date that Met QC Criteria

Feb 9, 2018

First Posted Date

Feb 15, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 9, 2018

Last Update Posted Date

Feb 15, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Heat sensation changes	the severity of hot flashes score changes	12 weeks after excercise

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

47 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ahmed Maged, MD	Contact	+2001005227404		prof.ahmedmaged@gmail.com
Amr Abassy, MD	Contact			women.health2012@gmail.com

Overall Officials

Name	Affiliation	Role
Ahmed Maged, MD	professor	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kasr Alainy medical school	Recruiting	Cairo		12151	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D019584	Hot Flashes

Ancestor Terms

ID	Term
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

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Browse Branches

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