Back to resultsEffect Of Treadmill Based Aerobic Exercise Intervention On Menstruation And Quality Of Life In Women With Polycystic Ovarian Syndrome
Primary Purpose
Polycystic Ovary Syndrome, Irregular Menses
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Treadmill exercise
low caloric diet
Sponsored by
About this trial
This is an interventional treatment trial for Polycystic Ovary Syndrome
Eligibility Criteria
Inclusion Criteria:
- women with pco
- age from17 to 28 years
- BMI 25- 30
Exclusion Criteria:
- Asthma and chronic respiratory disease
- congenital spinal problems
- cardiopulmonary disease
- physical impairments
Sites / Locations
- Cairo UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
low caloric diet
treadmill
Arm Description
low caloric diet 1200cal/day
treadmill aerobic exercise training
Outcomes
Primary Outcome Measures
menstrual regularity
Oligomenorrhea (menses every 6 weeks to 6 months), amenorrhea (menses greater than every 6 months apart or their absence), regular ( menses every 28-35 days)
quality of life questionnaire (QOLQ)
a total of 26 items for the Polycystic Ovary Syndrome Questionnaire, each question is associated with a 7-point scale in which 7 represents optimal function and 1 represents the poorest function
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04744948
Brief Title
Effect Of Treadmill Based Aerobic Exercise Intervention On Menstruation And Quality Of Life In Women With Polycystic Ovarian Syndrome
Official Title
Effect Of Treadmill Based Aerobic Exercise Intervention On Menstruation And Quality Of Life In Women With Polycystic Ovarian Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2021 (Anticipated)
Primary Completion Date
January 30, 2022 (Anticipated)
Study Completion Date
February 28, 2022 (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
this study will be carried to investigate the effect of aerobic exercise on menstrual regularity and quality of life in pco women
Detailed Description
This study will be carried out on sixty females with polycystic ovarian syndrome (PCOS) patients will be randomly assigned into two equal groups: control group (30 women) will receive low caloric diet 1200 Cal/day) while study group (30 women) will receive the same diet regime and treadmill aeobic exercise
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome, Irregular Menses
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
control group receive low caloric diet study group receive high intensity interval training
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
low caloric diet
Arm Type
Placebo Comparator
Arm Description
low caloric diet 1200cal/day
Arm Title
treadmill
Arm Type
Experimental
Arm Description
treadmill aerobic exercise training
Intervention Type
Device
Intervention Name(s)
Treadmill exercise
Intervention Description
high intensity interval training
Intervention Type
Other
Intervention Name(s)
low caloric diet
Intervention Description
low caloric diet (1200ca/lday)
Primary Outcome Measure Information:
Title
menstrual regularity
Description
Oligomenorrhea (menses every 6 weeks to 6 months), amenorrhea (menses greater than every 6 months apart or their absence), regular ( menses every 28-35 days)
Time Frame
3 months
Title
quality of life questionnaire (QOLQ)
Description
a total of 26 items for the Polycystic Ovary Syndrome Questionnaire, each question is associated with a 7-point scale in which 7 represents optimal function and 1 represents the poorest function
Time Frame
3 months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
female hormones
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
28 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
women with pco
age from17 to 28 years
BMI 25- 30
Exclusion Criteria:
Asthma and chronic respiratory disease
congenital spinal problems
cardiopulmonary disease
physical impairments
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
miral m saleh, md
Phone
01200678845
Ext
+012
Email
marmooramido@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
fahema m okiel, phd
Organizational Affiliation
Cairo University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
amal mo youssef, phd
Organizational Affiliation
Cairo University
Official's Role
Study Chair
Facility Information:
Facility Name
Cairo University
City
Cairo
ZIP/Postal Code
14788
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
miral s mohamed, md
Phone
01200678845
Ext
+012
Email
marmooramido@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Effect Of Treadmill Based Aerobic Exercise Intervention On Menstruation And Quality Of Life In Women With Polycystic Ovarian Syndrome
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