Back to resultsEffect of Aerobic Exercises With Selected Phytoestrogens on Hot Flushes in Menopausal Women
Primary Purpose
Hot Flashes
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Aerobic excercise
soy products
Sponsored by
About this trial
This is an interventional treatment trial for Hot Flashes
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.
Sites / Locations
- Kasr Alainy medical schoolRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Aerobic excercise
Dietary modfications
Arm Description
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
women who received diet modification contains soy products (phytoestrogen) such as soy milk and soy beans every day for 12 weeks only
Outcomes
Primary Outcome Measures
Heat sensation changes
the severity of hot flashes score changes
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03434171
Brief Title
Effect of Aerobic Exercises With Selected Phytoestrogens on Hot Flushes in Menopausal Women
Official Title
Effect of Aerobic Exercises With Selected Phytoestrogen Product on Hot Flushes in Post-menopausal Women
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
March 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hot Flashes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Aerobic excercise
Arm Type
Active Comparator
Arm Description
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
Arm Title
Dietary modfications
Arm Type
Active Comparator
Arm Description
women who received diet modification contains soy products (phytoestrogen) such as soy milk and soy beans every day for 12 weeks only
Intervention Type
Behavioral
Intervention Name(s)
Aerobic excercise
Other Intervention Name(s)
trademill
Intervention Description
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
Dietary Supplement
Intervention Name(s)
soy products
Intervention Description
diet modification contains soy products (phytoestrogen) such as soy milk and soy beans every day for 12 weeks only
Primary Outcome Measure Information:
Title
Heat sensation changes
Description
the severity of hot flashes score changes
Time Frame
12 weeks after excercise
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
47 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Maged, MD
Phone
+2001005227404
Email
prof.ahmedmaged@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Amr Abassy, MD
Email
women.health2012@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Maged, MD
Organizational Affiliation
professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kasr Alainy medical school
City
Cairo
ZIP/Postal Code
12151
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Maged, MD
Phone
01005227404
Email
prof.ahmedmaged@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effect of Aerobic Exercises With Selected Phytoestrogens on Hot Flushes in Menopausal Women
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