Effect of Aerobics on Physical and Mental Health in Polycystic Ovary Syndrome

Sponsor
Muhammad Irfan (Other)
Overall Status
Recruiting
CT.gov ID
NCT05577949
Collaborator
(none)
176
4
2
7.9
44
5.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Structured aerobics exercise
N/A

Detailed Description

Polycystic ovary syndrome is also referred to as "Hyperandrogenic anovulation or Stein Levinthal Syndrome". It has affected approximately 10 % of women of childbearing age. The prevalence of PCOS is higher among Pakistani women i.e. 52% as compared to the UK. The Rotterdam criteria are internationally used for the diagnosis of PCOS, which requires two out of the three features: signs of hyperandrogenism, ovulatory dysfunction, and ultrasound features of PCOS.

Although physical symptoms are increasingly recognized in women with PCOS, little attention has been paid to the mental health and well-being of these patients. PCOS creates an important psychological burden throughout the lifetime of these women. 57% of women with polycystic ovary syndrome have at least one mental disorder. Also, mental health is an essential part of public health and it is one of the most important indicators of the quality of health care in society.

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 a lowered quality of life. In a healthy population, lifestyle modifications, particularly physical activity, and exercise play a pivotal role in the optimization of mental health but there is little evidence available to demonstrate the effects of exercise on the optimization of psychological well-being and physical health of women with PCOS. So, this study has been designed to study the effect of a structured aerobics exercise program on the mental and physical health of women with PCOS.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
176 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Effect of Structured Aerobics Exercise Programme for the Improvement of Mental and Physical Health Parameters in Patients With Polycystic Ovary Syndrome: A Randomised Controlled Trial
Actual Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Mar 31, 2023
Anticipated Study Completion Date :
Apr 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Aerobics

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

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

No Intervention: Management used as "Treatment As Usual"

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

Outcome Measures

Primary Outcome Measures

  1. PCOS Quality of Life scale [12 weeks (3 months)]

    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.

  2. Hospital Anxiety and Depression Scale [12 weeks (3 months)]

    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

Secondary Outcome Measures

  1. ENRICH marital satisfaction scale [12 weeks (3 months)]

    Change in the score of the ENRICH marital satisfaction scale from baseline to midway to end of therapy, higher scores mean better marital satisfaction.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 49 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

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

Exclusion Criteria:
  1. Women that do not own personal smartphones

  2. Patients with endocrinological diseases like diabetes mellitus

  3. Thyroid, adrenal, or pituitary dysfunction

  4. Hepatic and pulmonary diseases

  5. Orthopedic

  6. Other diseases which can limit their physical activity or make it hazardous for them

  7. Participants with significant cognitive impairment, like intellectual disability or dementia, or active psychosis.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hayatabad Medical Complex Peshawar Khyber Pakhtunkhwa Pakistan
2 Khyber teaching hospital Peshawar Khyber Pakhtunkhwa Pakistan
3 Northwest teaching hospital and research centre Peshawar Khyber Pakhtunkhwa Pakistan
4 Mercy teaching hospital Peshawar Khyber Pukhtunkhwa Pakistan

Sponsors and Collaborators

  • Muhammad Irfan

Investigators

  • Principal Investigator: Rabia Kareem, MBBS,FCPS, Peshawar Medical College

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Muhammad Irfan, Professor & Head, Department of Mental Health, Psychiatry and Behavioural Sciences, Peshawar Medical College
ClinicalTrials.gov Identifier:
NCT05577949
Other Study ID Numbers:
  • Aerobics & PCOs
First Posted:
Oct 13, 2022
Last Update Posted:
Oct 13, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Muhammad Irfan, Professor & Head, Department of Mental Health, Psychiatry and Behavioural Sciences, Peshawar Medical College
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 13, 2022