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)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 5

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 Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome; Irregular Menses	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

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	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

	Site	City	State	Country	Postal Code
1	Cairo University	Cairo		Egypt	14788

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: Polycystic Ovary Syndrome; Syndrome; Menstruation Disturbances

Study Results

No Results Posted as of Feb 23, 2021