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CTRI Number  CTRI/2025/08/092642 [Registered on: 08/08/2025] Trial Registered Prospectively
Last Modified On: 07/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effectiveness of exercises intervention on physical and physiological parameters of adolescents with PCOS. 
Scientific Title of Study   Effectiveness of structured and supervised exercise intervention on physical and physiological parameters in adolescents with Polycystic ovary syndrome: A randomized controlled trial  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shweta Bhatbolan  
Designation  Associate Professor, PhD Scholar 
Affiliation  SDMCPT, SDM UNIVERSITY  
Address  SDMMC&H, Manjushree Nagar Sattur Dharwad

Dharwad
KARNATAKA
580009
India 
Phone  9916067268  
Fax    
Email  shweta.bhatbolan@sdmuniversity.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr. Sanjay Parmar  
Designation  Professor 
Affiliation  SDMCPT, SDM UNIVERSITY  
Address  SDMCPT, manjushree Nagar Sattur Dharwad Karnataka
Manjushree Nagar Sattur Dharwad
Dharwad
KARNATAKA
580009
India 
Phone  9916067268  
Fax    
Email  sanjaytparmar777@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr. Shweta Bhatbolan  
Designation  Associate Professor, PhD Scholar 
Affiliation  SDMCPT, SDM UNIVERSITY  
Address  SDMCPT, manjushree Nagar Sattur Dharwad

Dharwad
KARNATAKA
580009
India 
Phone  9916067268  
Fax    
Email  shweta.bhatbolan@sdmuniversity.edu.in  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  SDMMCH SDM UNIVERSITY  
Address  Manjushree, Nagar Sattur Dharwad, Karnataka Pincode 580009 
Type of Sponsor  Private medical college 
 
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 
Shweta Bhatbolan   SDM medical College and Hospital   Room no. 13, first floor Main building, Department of OBG Physiotherapy Manjushree Nagar, Sattur Dharwad
Dharwad
KARNATAKA 		 9916067268

shweta.bhatbolan@sdmuniversity.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SDM institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Polycystic Ovary Syndrome  
Patients  (1) ICD-10 Condition: E282||Polycystic ovarian syndrome,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Structured and supervised exercise  The structured but supervised exercise intervention program will be prescribed after baseline assessment. The patient should come for 3 to 4 sessions in a week for supervised program a total of 36 supervised sessions within 3 months time. And every 15 th day a progression will be given on the exercise program. Every 15th day or 2 times in a month the patient should come for follow up On follow up the progression on exercise will be given Total 7 times contact within 3 months time. 
Comparator Agent  Structured exercise program without supervision but adherence calendar will be provided   Exercise will be structured as per the baseline assessment and every 15 th day a follow up will be taken and progression will be given for exercise program A total of 7 visits and last or 7th visit the post intervention assessment will be taken on the outcome measures specified 
 
Inclusion Criteria  
Age From  17.00 Year(s)
Age To  19.00 Year(s)
Gender  Female 
Details  Identified to have irregularities of menstrual cycle and diagnosed of PCOS as per Rotterdam Criteria  
 
ExclusionCriteria 
Details  Women in Antenatal or Post natal period

Diagnosed cases of genetic disorder or neurodevelopmental disorder

Any recent surgeries
Any musculoskeletal complains that prohibits the exercise participation 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Anthropometric measurements
Weight
Body composition analysis- Karada scan
Regularity of menstrual cycle

 		 Baseline and after 12 weeks
 
 
Secondary Outcome  
Outcome  TimePoints 
Hormone profile
LH FSH
Fasting blood glucose levels and HbA1C 		 Baseline and after 12 weeks  
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
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)   06/10/2025 
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="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 first line management of PCOS is the improvement in the lifestyle, however, there are limited studies on whether any treatment may be useful in improving the PCOS manifestation in adolescence towards adulthood this understanding of the effectiveness of structured exercise will pave a path for further research as well as an understanding on how well the exercises can be utilised as the treatment method for adolescents with PCOS  
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