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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Polycystic Ovary Syndrome
• Intervention / Treatment: Other: Structured aerobics exercise

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 Type: Interventional
• Enrollment (Anticipated): 176
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Muhammad Irfan, FCPS,MS,PhD; Phone Number: +923339123625; Email: mirfan78@yahoo.com
• Study Contact Backup: Name: Mifrah R Sethi, MSc, Mphil; Email: mifrahrauf@gmail.com

Study Locations

• Pakistan
  • Khyber Pakhtunkhwa
    • Peshawar, Khyber Pakhtunkhwa, Pakistan
      • Recruiting
      • Hayatabad Medical Complex
      • Contact: Rukhsana Karim, MBBS,FCPS
    • Peshawar, Khyber Pakhtunkhwa, Pakistan
      • Recruiting
      • Khyber Teaching Hospital
      • Contact: Mahjabina S Ghayur, MBBS, FCPS
    • Peshawar, Khyber Pakhtunkhwa, Pakistan
      • Recruiting
      • Northwest teaching hospital and research centre
      • Contact: Sumaira Inayat, MBBS,FCPS
  • Khyber Pukhtunkhwa
    • Peshawar, Khyber Pukhtunkhwa, Pakistan
      • Recruiting
      • Mercy teaching hospital
      • Contact: Samdana Wahab, MBBS,FCPS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
ENRICH marital satisfaction scale	Change in the score of the ENRICH marital satisfaction scale from baseline to midway to end of therapy, higher scores mean better marital satisfaction.	12 weeks (3 months)

Collaborators and Investigators

• Sponsor: Muhammad Irfan
• Investigators: Principal Investigator: Rabia Kareem, MBBS,FCPS, Peshawar Medical College

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Anticipated): March 31, 2023
• Study Completion (Anticipated): April 30, 2023

Study Registration Dates

• First Submitted: October 5, 2022
• First Submitted That Met QC Criteria: October 7, 2022
• First Posted (Actual): October 13, 2022

Study Record Updates

• Last Update Posted (Actual): October 13, 2022
• Last Update Submitted That Met QC Criteria: October 7, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Mental health; Physical health; Structured aerobics exercise program
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Polycystic Ovary Syndrome; Syndrome
• Other Study ID Numbers: Aerobics & PCOs

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No