NCT05577949

Brief Summary

Polycystic ovary is one of the most common metabolic and endocrine disorders in women of reproductive age group. The Rotterdam criteria are used internationally for its diagnosis. It has been reported that 57% of these women have at least one mental disorder. There is no health without mental health and it is fundamental to the good health and well-being of an individual. Women with PCOS are at risk of a wide range of significant psychological difficulties including depression, anxiety, eating disorders, sexual disorders, low self-esteem, poor body image, and overall low quality of life. In the healthy population, exercise plays a pivotal role in the optimization of mental health, but there is little evidence available to demonstrate its effects on women with PCOS. So, this study has been designed to study the effects of structured aerobics exercise programs on the mental and physical health of women with PCOS.

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
176

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

4 active sites

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

Study Start

First participant enrolled

September 1, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 5, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 13, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

October 13, 2022

Status Verified

October 1, 2022

Enrollment Period

7 months

First QC Date

October 5, 2022

Last Update Submit

October 7, 2022

Conditions

Polycystic Ovary Syndrome

Keywords

Structured aerobics exercise programPhysical healthMental health

Outcome Measures

Primary Outcomes (2)

  • PCOS Quality of Life scale

    Change in the score of the PCO quality of life scale from baseline to midway to end of therapy, higher scores mean a better quality of life.

    12 weeks (3 months)

  • Hospital Anxiety and Depression Scale

    Change in the score of the Hospital anxiety and depression scale from baseline to midway to end of therapy, 0-7 indicates normal, 8 to 10 indicates borderline and 11-21 indicates abnormal cases. Higher scores mean a worse outcome

    12 weeks (3 months)

Secondary Outcomes (1)

  • ENRICH marital satisfaction scale

    12 weeks (3 months)

Study Arms (2)

Aerobics

EXPERIMENTAL

This group will perform structured aerobics exercise program in addition to the standard treatment given for women with PCOS.

Other: Structured aerobics exercise

Management used as "Treatment As Usual"

NO INTERVENTION

This group will receive the standard management given for women with PCOS

Interventions

Structured aerobics exerciseOTHER

A 12 week structured aerobics exercise program will be offered. The patient has to perform exercise five times a week , 30 minutes a day

Aerobics

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • All women diagnosed with PCOS according to the Rotterdam criteria with the age range of 18-49 years

You may not qualify if:

  • Women that do not own personal smartphones
  • Patients with endocrinological diseases like diabetes mellitus
  • Thyroid, adrenal, or pituitary dysfunction
  • Hepatic and pulmonary diseases
  • Orthopedic
  • Other diseases which can limit their physical activity or make it hazardous for them
  • Participants with significant cognitive impairment, like intellectual disability or dementia, or active psychosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hayatabad Medical Complex

Peshawar, Khyber Pakhtunkhwa, Pakistan

RECRUITING

Khyber teaching hospital

Peshawar, Khyber Pakhtunkhwa, Pakistan

RECRUITING

Northwest teaching hospital and research centre

Peshawar, Khyber Pakhtunkhwa, Pakistan

RECRUITING

Mercy teaching hospital

Peshawar, Khyber Pukhtunkhwa, Pakistan

RECRUITING

MeSH Terms

Conditions

Polycystic Ovary SyndromePsychological Well-Being

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesPersonal SatisfactionBehavior

Study Officials

  • Rabia Kareem, MBBS,FCPS

    Peshawar Medical College

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad Irfan, FCPS,MS,PhD

CONTACT

+923339123625mirfan78@yahoo.com

Mifrah R Sethi, MSc, Mphil

CONTACT

mifrahrauf@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor & Head, Department of Mental Health, Psychiatry and Behavioural Sciences

Study Record Dates

First Submitted

October 5, 2022

First Posted

October 13, 2022

Study Start

September 1, 2022

Primary Completion

March 31, 2023

Study Completion

April 30, 2023

Last Updated

October 13, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

PA(4)