Clinical trial NCT05577949: Effect of Aerobics on Physical and Mental Health in Polycystic Ovary Syndrome
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Polycystic Ovary Syndrome
Keywords: Structured aerobics exercise program
Physical health
Mental health
Lead sponsor: Peshawar Medical College
Sponsor class: OTHER
First posted: 2022-10-13
Enrollment: 176
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: PCOS Quality of Life scale
timeFrame: 12 weeks (3 months)
measure: Hospital Anxiety and Depression Scale
timeFrame: 12 weeks (3 months)
Secondary outcomes:
measure: ENRICH marital satisfaction scale
timeFrame: 12 weeks (3 months)
Other outcomes:
Locations:
city: Peshawar
country: Pakistan
facility: Hayatabad Medical Complex
state: Khyber Pakhtunkhwa
city: Peshawar
country: Pakistan
facility: Khyber teaching hospital
state: Khyber Pakhtunkhwa
city: Peshawar
country: Pakistan
facility: Northwest teaching hospital and research centre
state: Khyber Pakhtunkhwa
city: Peshawar
country: Pakistan
facility: Mercy teaching hospital
state: Khyber Pukhtunkhwa
Study officials:
affiliation: Peshawar Medical College
name: Rabia Kareem, MBBS,FCPS
role: PRINCIPAL_INVESTIGATOR
References: