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

Polycystic Ovary Syndrome Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05577949
• Other study ID #: Aerobics & PCOs
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: April 30, 2023

Study information

• Verified date: October 2022
• Source: Peshawar Medical College
• Contact: Muhammad Irfan, FCPS,MS,PhD
• Phone: +923339123625
• Email: mirfan78[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 176
• Est. completion date: April 30, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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.

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Pakistan	Hayatabad Medical Complex	Peshawar	Khyber Pakhtunkhwa
Pakistan	Khyber teaching hospital	Peshawar	Khyber Pakhtunkhwa
Pakistan	Mercy teaching hospital	Peshawar	Khyber Pukhtunkhwa
Pakistan	Northwest teaching hospital and research centre	Peshawar	Khyber Pakhtunkhwa

Sponsors (1)

Lead Sponsor	Collaborator
Muhammad Irfan

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)