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CTRI Number  CTRI/2024/10/075007 [Registered on: 09/10/2024] Trial Registered Prospectively
Last Modified On: 11/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Understanding the Factors Influencing Exercise Behaviour Among Women With Polycystic Ovarian Syndrome  
Scientific Title of Study   Analysing the Factors Influencing Exercise Behaviour Among Women With Polycystic Ovarian Syndrome A Structural Equation Modelling Approach 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kritika sethi 
Designation  Physiotherapist 
Affiliation  Postgraduate Institute of Medical Education and Research  
Address  Department of PRM,Physiotherapy Section, Postgraduate Institute of Medical Education and Research, Sector 12,Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9643729792  
Fax    
Email  kritika.sethi173@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  NARINDER KAUR MULTANI 
Designation  PROFESSOR 
Affiliation  PUNJABI UNIVERSITY 
Address  Department of Physiotherapy, Punjabi University, Patiala

Patiala
PUNJAB
147002
India 
Phone  9872990138  
Fax    
Email  drnkmultani@gmail.com  
 
Details of Contact Person
Public Query
 
Name  NARINDER KAUR MULTANI 
Designation  PROFESSOR 
Affiliation  PUNJABI UNIVERSITY 
Address  Department of Physiotherapy, Punjabi University, Patiala

Patiala
PUNJAB
147002
India 
Phone  9872990138  
Fax    
Email  drnkmultani@gmail.com  
 
Source of Monetary or Material Support  
Postgraduate Institute of Medical Education and Research, sector 12, Chandigarh 160012, India 
 
Primary Sponsor  
Name  Not Applicable 
Address  Not applicable 
Type of Sponsor  Other [Not Applicable] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Amanjot Kaur  PGIMER  Department of Obestetrics and Gynaecology Postgraduate Institute of Medical Education and Research Sector 12 Chandigarh 160 012
Chandigarh
CHANDIGARH 
8437000718

aman50055@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Post Graduate Institute of Medical Education and Research Chandigarh Institutional Ethics Committee Intramural  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E888||Other specified metabolic disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Adult female (18-45 years) with prior diagnosis of PCOS 
 
ExclusionCriteria 
Details  Pregnant women, Any major diagnosed chronic disease i.e., diabetes, hypertension, kidney disease, and thyroid disease,Unable to comprehend the given questionnaire in English language,Women with a diagnosed psychiatric illness other than anxiety and depression 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Factors affecting exercise behaviour in women with PCOS questionnaire  One time 
 
Secondary Outcome  
Outcome  TimePoints 
not applicable  not applicable 
 
Target Sample Size   Total Sample Size="322"
Sample Size from India="322" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/01/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

This research proposal is aimed to identify the factors that influence exercise behaviour in women with Polycystic ovary syndrome (PCOS).  PCOS is one of the most common and multi factorial disorders that has symptoms and co morbidities which can have their effect throughout the lifespan of a women. According to Endocrine Society Clinical Practice Guidelines lifestyle modification which include diet, eating habits and exercise is regarded as first line of treatment in PCOS.There are several evidences which shows the positive effect of exercise on women reproductive and mental health. However, evidences from all over the world shows that there is a need to create awareness among people about PCOS and how exercise can help them resolve problems related to it. Inspite of the established benefits of exercise and lifestyle modification in PCOS, a small extent of the population implement it to themselves. Therefore, identifying factors that are preventing women suffering from PCOS from engaging in exercises is very crucial.

In this cross sectional study subjects will be recruited from Gynaecology department, PGIMER, Chandigarh, India and convenience sampling will be done. The inclusion criteria include adult female (18-45 years) with prior diagnosis of PCOS.  Any female who is pregnant, have any major chronic disease, have any diagnosed psychiatric illness other than anxiety and depression or is unable to comprehend the given questionnaire in English language will be excluded from the study. The study will be done in two phases. Phase 1 will include development and validation of questionnaire and phase 2 will include implementation of final questionnaire on the target population for data collection. Health Belief Model will be used for conceptual framework. Structural Equation Modelling approach will be used for data analysis. Confirmatory factor analysis will be done on the data collected and conclusion will be drawn from the result obtained.

 

 
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