Effect Of Treadmill Based Aerobic Exercise Intervention On Menstruation And Quality Of Life In Women With Polycystic Ovarian Syndrome

February 21, 2021 updated by: Miral Saleh Mohamed, Cairo University
this study will be carried to investigate the effect of aerobic exercise on menstrual regularity and quality of life in pco women

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 14788
        • Recruiting
        • Cairo University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 28 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: low caloric diet
low caloric diet 1200cal/day
Other: low caloric diet
low caloric diet (1200ca/lday)
Experimental: treadmill
treadmill aerobic exercise training
Other: low caloric diet
low caloric diet (1200ca/lday)
Device: Treadmill exercise
high intensity interval training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
menstrual regularity
Time Frame: 3 months
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)
3 months
quality of life questionnaire (QOLQ)
Time Frame: 3 months
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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Chair: amal mo youssef, phd, Cairo University
  • Study Director: fahema m okiel, phd, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2021

Primary Completion (Anticipated)

January 30, 2022

Study Completion (Anticipated)

February 28, 2022

Study Registration Dates

First Submitted

February 3, 2021

First Submitted That Met QC Criteria

February 4, 2021

First Posted (Actual)

February 9, 2021

Study Record Updates

Last Update Posted (Actual)

February 23, 2021

Last Update Submitted That Met QC Criteria

February 21, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ETMQWP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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