| 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
|
|
|
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
|
|
|
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. |