| CTRI Number |
CTRI/2025/04/085069 [Registered on: 17/04/2025] Trial Registered Prospectively |
| Last Modified On: |
17/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Studying How Physical Activity and Energy Use Affect Body Composition and Health in Women with PCOS and Healthy Women |
|
Scientific Title of Study
|
Association between energy expenditure, physical activity and body composition among polycystic ovarian syndrome (PCOS) and healthy young women |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vijayshree S V |
| Designation |
Post graduate student |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
PT 22, 4th floor, SRM College of Physiotherapy, SRM Medical College Building, SRM Institute of science and technology, SRM nagar, kattankulathur, potheri
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
8189857077 |
| Fax |
|
| Email |
vijayshree19052002@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vijayshree S V |
| Designation |
Post graduate student |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
PT 22, 4th floor, SRM College of Physiotherapy, SRM Medical College Building, SRM Institute of science and technology, SRM nagar, kattankulathur, potheri
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
8189857077 |
| Fax |
|
| Email |
vijayshree19052002@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Gayathri K |
| Designation |
Assistant Professor |
| Affiliation |
SRM Institute of science and technology |
| Address |
PT 22, 4th floor, SRM College of Physiotherapy, SRM Medical College Building, SRM Institute of science and technology, SRM nagar, kattankulathur, potheri
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9840782628 |
| Fax |
|
| Email |
gayathrk1@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| SRM College of Physiotherapy, SRM Medical College Hospital and Research Centre, SRM nagar, Kattankulathur, Potheri, Chengalpattu district, TamilNadu, India. PIN 603203 |
|
|
Primary Sponsor
|
| Name |
Vijayshree S V |
| Address |
Room no: PT 22, Fourth floor,SRM College of Physiotherapy, SRM Institute of science and technology, SRM Medical College Hospital and Research Centre, SRM nagar, Kattankulathur, Potheri, Chengalpattu district, TamilNadu, India. PIN 603203 |
| Type of Sponsor |
Other [Self funding] |
|
|
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 |
| Vijayshree S V |
SRM Medical College Hospital And Research Centre |
Room no: 19, Fifth floor, Cardio lab, SRM College of Physiotherapy, SRM Medical College Hospital Research Centre, SRM Institute of Science and Technology, SRM Nagar, Kattankulathur, Potheri,Chengalattu district, Tamil Nadu, India. PIN 603203
Kancheepuram
TAMIL NADU |
8189857077
vijayshree19052002@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Medical College Hospital and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E282||Polycystic ovarian syndrome, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
26.00 Year(s) |
| Gender |
Female |
| Details |
•Young women of age group 18 to 26 years
•Nulliparous women
•BMI Underweight and normal 18.5 to 22.9 kg per m2 Overweight and obese 23.0 to 30.0 kgm2
GROUP A
Subjects with PCOS
•Self reported clinically diagnosed PCOS
•PCOS confirmed by Clinical tool for diagnosis of PCOS of score greater than or equal to 2
GROUP B
Subjects without PCOS
•Healthy young women
•Subjects with regular menstrual cycle
•Subjects without PCOS is confirmed by Clinical tool for diagnosis of PCOS of score less than 2
|
|
| ExclusionCriteria |
| Details |
•Subjects with cardiovascular disease, pulmonary, liver or renal disease, neuromuscular disease and musculoskeletal disorders.
•Subjects with known case of chronic medical conditions, systemic diseases or metabolic diseases such as diabetes mellitus, hypertension, thyroid and under medications.
•Subjects currently under menstruation phase and with associated illness.
•Subjects not willing to participate.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
PCOS is confirmed through Clinical Tool for diagnosis of PCOS
Energy expenditure will be assessed through Physiological Cost Index PCI= (Working HR-Rest HR)/Walking Speed
Physical Activity will be assessed through International Physical Activity Questionnaire (IPAQ)
Body Coposition will be assessed through Body Fat Analyser |
5 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Other variables such as height, weight, BMI |
5 months |
|
|
Target Sample Size
|
Total Sample Size="214"
Sample Size from India="214"
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)
|
30/04/2025 |
| 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="0"
Months="6"
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
|
The study aims to assess the association between energy expenditure, physical activity, and body composition in self-reported clinically diagnosed PCOS patients and healthy young women. This cross-sectional research, conducted after Institutional Ethical Clearance, will categorize participants into two groups: Group A (PCOS) and Group B (healthy controls) based on a self-administered Clinical Tool for Diagnosis of PCOS. Physical activity will be measured using the International Physical Activity Questionnaire (IPAQ), while body composition will be analyzed with a body fat analyzer assessing BMI, fat percentage, muscle mass, and other parameters. Energy expenditure will be evaluated using the Timed 10-Meter Walk Test, where heart rate and walking speed will determine the Physiological Cost Index (PCI). The study aims to identify the association between these variables in both groups, providing insights into the physiological impact of PCOS. Statistical analysis will follow to interpret the findings. |