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

NCT ID: NCT05577949

Last Updated: 2022-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

176 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2023-04-30

Brief Summary

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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

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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.

Conditions

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Polycystic Ovary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Aerobics

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

Group Type EXPERIMENTAL

Structured aerobics exercise

Intervention Type OTHER

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

Management used as "Treatment As Usual"

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Muhammad Irfan

OTHER

Sponsor Role lead

Responsible Party

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Muhammad Irfan

Professor & Head, Department of Mental Health, Psychiatry and Behavioural Sciences

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Rabia Kareem, MBBS,FCPS

Role: PRINCIPAL_INVESTIGATOR

Peshawar Medical College

Locations

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Hayatabad Medical Complex

Peshawar, Khyber Pakhtunkhwa, Pakistan

Site Status RECRUITING

Khyber teaching hospital

Peshawar, Khyber Pakhtunkhwa, Pakistan

Site Status RECRUITING

Northwest teaching hospital and research centre

Peshawar, Khyber Pakhtunkhwa, Pakistan

Site Status RECRUITING

Mercy teaching hospital

Peshawar, Khyber Pukhtunkhwa, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Muhammad Irfan, FCPS,MS,PhD

Role: CONTACT

+923339123625

Mifrah R Sethi, MSc, Mphil

Role: CONTACT

Facility Contacts

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Rukhsana Karim, MBBS,FCPS

Role: primary

Mahjabina S Ghayur, MBBS, FCPS

Role: primary

Sumaira Inayat, MBBS,FCPS

Role: primary

Samdana Wahab, MBBS,FCPS

Role: primary

Other Identifiers

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Aerobics & PCOs

Identifier Type: -

Identifier Source: org_study_id

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