search
Back to results

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

Primary Purpose

Polycystic Ovary Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Structured aerobics exercise
Sponsored by
Muhammad Irfan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring Structured aerobics exercise program, Physical health, Mental health

Eligibility Criteria

18 Years - 49 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Hayatabad Medical ComplexRecruiting
  • Khyber teaching hospitalRecruiting
  • Northwest teaching hospital and research centreRecruiting
  • Mercy teaching hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Aerobics

Management used as "Treatment As Usual"

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

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.

Full Information

First Posted
October 5, 2022
Last Updated
October 7, 2022
Sponsor
Muhammad Irfan
search

1. Study Identification

Unique Protocol Identification Number
NCT05577949
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
April 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Muhammad Irfan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
Keywords
Structured aerobics exercise program, Physical health, Mental health

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
176 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aerobics
Arm Type
Experimental
Arm Description
This group will perform structured aerobics exercise program in addition to the standard treatment given for women with PCOS.
Arm Title
Management used as "Treatment As Usual"
Arm Type
No Intervention
Arm Description
This group will receive the standard management given for women with PCOS
Intervention Type
Other
Intervention Name(s)
Structured aerobics exercise
Intervention Description
A 12 week structured aerobics exercise program will be offered. The patient has to perform exercise five times a week , 30 minutes a day
Primary Outcome Measure Information:
Title
PCOS Quality of Life scale
Description
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.
Time Frame
12 weeks (3 months)
Title
Hospital Anxiety and Depression Scale
Description
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
Time Frame
12 weeks (3 months)
Secondary Outcome Measure Information:
Title
ENRICH marital satisfaction scale
Description
Change in the score of the ENRICH marital satisfaction scale from baseline to midway to end of therapy, higher scores mean better marital satisfaction.
Time Frame
12 weeks (3 months)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: All women diagnosed with PCOS according to the Rotterdam criteria with the age range of 18-49 years Exclusion Criteria: Women that do not own personal smartphones Patients with endocrinological diseases like diabetes mellitus Thyroid, adrenal, or pituitary dysfunction Hepatic and pulmonary diseases Orthopedic Other diseases which can limit their physical activity or make it hazardous for them Participants with significant cognitive impairment, like intellectual disability or dementia, or active psychosis.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Muhammad Irfan, FCPS,MS,PhD
Phone
+923339123625
Email
mirfan78@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mifrah R Sethi, MSc, Mphil
Email
mifrahrauf@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rabia Kareem, MBBS,FCPS
Organizational Affiliation
Peshawar Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hayatabad Medical Complex
City
Peshawar
State/Province
Khyber Pakhtunkhwa
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rukhsana Karim, MBBS,FCPS
Facility Name
Khyber teaching hospital
City
Peshawar
State/Province
Khyber Pakhtunkhwa
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahjabina S Ghayur, MBBS, FCPS
Facility Name
Northwest teaching hospital and research centre
City
Peshawar
State/Province
Khyber Pakhtunkhwa
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sumaira Inayat, MBBS,FCPS
Facility Name
Mercy teaching hospital
City
Peshawar
State/Province
Khyber Pukhtunkhwa
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samdana Wahab, MBBS,FCPS

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs