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CTRI Number  CTRI/2024/08/071815 [Registered on: 02/08/2024] Trial Registered Prospectively
Last Modified On: 30/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Promoting well-being with customized exercise: Research on Adolescent Females with Polycystic Ovarian Syndrome 
Scientific Title of Study   Effects of an Individualized Exercise Program on Body composition, Lipid Profile, Mental Health and Ovarian cysts in Young Women with Polycystic Ovarian Syndrome. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jeslin G N 
Designation  PhD Scholar and Tutor 
Affiliation  Saveetha College of Physiotherapy 
Address  A5, 5th floor, Health Sciences Block, Saveetha College of Physiotherapy, Saveetha Institute of Medical and Technical Sciences, Saveetha Nagar, Thandalam, Chennai

Chennai
TAMIL NADU
602105
India 
Phone  9360729854  
Fax    
Email  jessygodwin.n@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Prathap Suganthirababu 
Designation  Principal & Professor 
Affiliation  Saveetha College of Physiotherapy 
Address  Office of the Principal, 4th floor, Health Sciences Block, Saveetha College of Physiotherapy, Saveetha Institute of Medical and Technical Sciences, Saveetha Nagar, Thandalam, Chennai

Chennai
TAMIL NADU
602105
India 
Phone  9840340195  
Fax    
Email  principalphysiotherapy@saveetha.com  
 
Details of Contact Person
Public Query  
Name  Jeslin G N 
Designation  Tutor 
Affiliation  Saveetha College of Physiotherapy 
Address  A5, 5th floor, Health Sciences Block, Saveetha College of Physiotherapy, Saveetha Institute of Medical and Technical Sciences, Saveetha Nagar, Thandalam, Chennai

Chennai
TAMIL NADU
602105
India 
Phone  9360729854  
Fax    
Email  jessygodwin.n@gmail.com  
 
Source of Monetary or Material Support  
Saveetha College of Physiotherapy, Saveetha Institute of Medical and Technical Sciences, Saveetha Nagar, Thandalam, Chennai, Tamil Nadu, India, Pincode - 602 105. 
 
Primary Sponsor  
Name  Dr Jeslin G N 
Address  Saveetha College of Physiotherapy, Saveetha Institute of Medical and Technical Sciences, Saveetha Nagar, Thandalam, Chennai, Tamil Nadu, India, Pincode - 602 105. 
Type of Sponsor  Other [Self] 
 
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 Prathap Suganthirababu  Saveetha Medical College and Hospitals, Saveetha Institute of Medical and Technical Sciences  1st floor, Department of Urology and Obstetrics Physiotherapy, Physiotherapy OPD, Saveetha Medical College and Hospitals, Saveetha Nagar, Thandalam, Chennai, Tamil Nadu, India, Pincode - 602 105.
Chennai
TAMIL NADU 		 9840340195

principalphysiotherapy@saveetha.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SMCH - INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E669||Obesity, unspecified, (2) ICD-10 Condition: E282||Polycystic ovarian syndrome,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Aerobic and Resistance Training  Total Duration - 9 weeks RESISTANCE TRAINING Intensity: 40 – 50% of 6 RM Repetitions: 8 – 12 reps Sets: 2 -3 sets Frequency: One session per day for 3 days a week Type: Split Routine Duration: 30minutes Day 1 – Chest/Triceps Chest Dumbbell Bench Press – flat Pectoralis Fly Dumbbell Bench Press – Inclined Triceps Cable Push Down Both arm Dumbbell Triceps extension Single arm Dumbbell Triceps extension Day 2 – Latissimus / Biceps Latissimus Lateral Pull Down Seated Row High Pulley Cable Row Biceps Dumbbell Biceps curl Dumbbell Hammer curl Cable Biceps curl Day 3 – Shoulders / Legs Shoulders Dumbbell Shoulder press Dumbbell Front Raise Dumbbell side Raise Legs Half Squats Lunges with Dumbbell Calf Raises Day 4 & 5 - AEROBIC TRAINING Type: Continuous Intensity: Moderate Mode: Walking / Cycling Duration: 30 minutes Frequency: 1 session per day for 5 days per week  
Comparator Agent  Aerobic training  Day 1 to 5 - AEROBIC TRAINING Type: Continuous Intensity: Moderate Mode: Walking / Cycling Duration: 30 minutes Frequency: 1 session per day for 5 days per week for 9 weeks 
Comparator Agent  Control group  No intervention until the end of the study duration 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Female 
Details  Young Women diagnosed with PCOS based on Rotterdam Criteria
BMI more than 25
Young Women with Low risk according to the ACSM Risk Stratification Guidelines
Young Women with PCOS cleared for physical activity as per 2023 Physical Activity Readiness - Questionnaire (PAR-Q+)
Young Women willing to comply with the study protocols and attend scheduled assessments
 
 
ExclusionCriteria 
Details  Pregnant Women
Classic Non cystic Phenotype of PCOS as per the Rotterdam Criteria
Untreated Hypothyroidism
Inflammatory Arthritis or any lower limb pathology which precludes exercise
History of Cardiopulmonary disorders
History of receiving more than 6 ovulation cycles with letrozole
History of Bariatric surgery
History of Renal Disorders
History of Liver Disorders
Abnormal as per Hospital Anxiety and Depression Scale (HADS)
Habitual Smokers & Alcohol Consumers


 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Transabdominal Ultrasonography
Lipid Profile
Body Composition (BMI, Waist Circumference, Hip Circumference, Waist Hip Ratio, Body fat Percentage) 		 Baseline to 9 Weeks of Post-Intervention 
 
Secondary Outcome  
Outcome  TimePoints 
Hospital Anxiety and Depression Scale (HADS)  Baseline to 9 Weeks of Post-Intervention 
 
Target Sample Size   Total Sample Size="162"
Sample Size from India="162" 
Final Enrollment numbers achieved (Total)= "162"
Final Enrollment numbers achieved (India)="162" 
Phase of Trial   N/A 
Date of First Enrollment (India)   12/08/2024 
Date of Study Completion (India) 30/12/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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   PCOS has grown to be common affecting the physical and mental well being of Young Women. This situation has sparked intense research on the addition of exercise regimens as part of lifestyle changes/ non pharmacological strategies of management. This study focuses on providing evidence based insights on deciding the best custom made exercise regime to manage the physical, psychological and metabolic disruptions. This study has planned to recruit 162 participants who will be grouped as three: Aerobic and Resistance Training Group, Aerobic Training Group and Control Group with 54 participants in each group. The interventions will be given for 9 weeks prior and after which the outcomes to assess Physical, Psychological and Metabolic parameters. 
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