NCT04744948

Brief Summary

this study will be carried to investigate the effect of aerobic exercise on menstrual regularity and quality of life in pco women

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 9, 2021

Completed
20 days until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2022

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
Last Updated

February 23, 2021

Status Verified

February 1, 2021

Enrollment Period

11 months

First QC Date

February 3, 2021

Last Update Submit

February 21, 2021

Conditions

Polycystic Ovary SyndromeIrregular Menses

Outcome Measures

Primary Outcomes (2)

  • 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)

    3 months

  • 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

    3 months

Study Arms (2)

low caloric diet

PLACEBO COMPARATOR

low caloric diet 1200cal/day

Other: low caloric diet

treadmill

EXPERIMENTAL

treadmill aerobic exercise training

Device: Treadmill exerciseOther: low caloric diet

Interventions

Treadmill exerciseDEVICE

high intensity interval training

treadmill
low caloric dietOTHER

low caloric diet (1200ca/lday)

low caloric diettreadmill

Eligibility Criteria

Age17 Years - 28 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale hormones
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • women with pco
  • age from17 to 28 years
  • BMI 25- 30

You may not qualify if:

  • Asthma and chronic respiratory disease
  • congenital spinal problems
  • cardiopulmonary disease
  • physical impairments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, 14788, Egypt

RECRUITING

MeSH Terms

Conditions

Polycystic Ovary SyndromeMenstruation Disturbances

Interventions

Caloric Restriction

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsEnergy IntakeDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • fahema m okiel, phd

    Cairo University

    STUDY DIRECTOR

  • amal mo youssef, phd

    Cairo University

    STUDY CHAIR

Central Study Contacts

miral m saleh, md

CONTACT

01200678845marmooramido@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: control group receive low caloric diet study group receive high intensity interval training
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

February 3, 2021

First Posted

February 9, 2021

Study Start

March 1, 2021

Primary Completion

January 30, 2022

Study Completion

February 28, 2022

Last Updated

February 23, 2021

Record last verified: 2021-02

Locations

EG(1)