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

Sponsor
Cairo University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04744948
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
12
Anticipated Duration (Months)
5
Patients Per Site Per Month

Study Details

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

Condition or DiseaseIntervention/TreatmentPhase
  • Device: Treadmill exercise
  • Other: low caloric diet
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
control group receive low caloric diet study group receive high intensity interval trainingcontrol group receive low caloric diet study group receive high intensity interval training
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect Of Treadmill Based Aerobic Exercise Intervention On Menstruation And Quality Of Life In Women With Polycystic Ovarian Syndrome
Anticipated Study Start Date :
Mar 1, 2021
Anticipated Primary Completion Date :
Jan 30, 2022
Anticipated Study Completion Date :
Feb 28, 2022

Arms and Interventions

ArmIntervention/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

Device: Treadmill exercise
high intensity interval training

Other: low caloric diet
low caloric diet (1200ca/lday)

Outcome Measures

Primary Outcome Measures

  1. menstrual regularity [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)

  2. quality of life questionnaire (QOLQ) [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
17 Years to 28 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Cairo UniversityCairoEgypt14788

Sponsors and Collaborators

  • Cairo University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Miral Saleh Mohamed, assistant lecturer, Cairo University
ClinicalTrials.gov Identifier:
NCT04744948
Other Study ID Numbers:
  • ETMQWP
First Posted:
Feb 9, 2021
Last Update Posted:
Feb 23, 2021
Last Verified:
Feb 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 23, 2021