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CTRI Number  CTRI/2025/07/090290 [Registered on: 07/07/2025] Trial Registered Prospectively
Last Modified On: 04/07/2025
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   Effect of structured Physiotherapy exercise among obese college girls with PCOS  
Scientific Title of Study   Effect of structured Exercise training over conventional exercise on physical, reproductive and quality of life among obese college girls with Polycystic ovarian disease – 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  Christy sopna s  
Designation  PhD Scholar , Assistant Professor in physiotherapy  
Affiliation  pondicherry university  
Address  Room No.1(staff room), Third floor, Department of physiotherapy, College of allied health sciences, East coast institute of medical sciences,No.1, paris nagar, moolakulam, puducherry

Pondicherry
PONDICHERRY
605010
India 
Phone  7339626450  
Fax    
Email  christysopna.jesus@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. V. RAJALAXMI  
Designation  vice principal & professor  
Affiliation  Dr. M.G.R Educational and research institute  
Address  Room no.3, ground floor, Faculty of physiotherapy, A.C.S medical college & hospital, velappanchavadi, chennai

Chennai
TAMIL NADU
600077
India 
Phone  9176123939  
Fax    
Email  rajalaxmiphysio@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Christy sopna s  
Designation  PhD Scholar , Assistant Professor in physiotherapy  
Affiliation  pondicherry university  
Address  Room No.1(staff room), Third floor, Department of physiotherapy, College of allied health sciences, East coast institute of medical sciences,No.1 paris nagar, moolakulam, puducherry

Pondicherry
PONDICHERRY
605010
India 
Phone  7339626450  
Fax    
Email  christysopna.jesus@gmail.com  
 
Source of Monetary or Material Support  
college of nursing , East coast institute of medical sciences college of allied health sciences, East coast institute of medical sciences Faculty of physiotherapy, ACS Medical college and Hospital  
 
Primary Sponsor  
Name  Christy sopna S  
Address  No.51, pump house street, gandhi thirunallur, muthirapalayam, puducherry - 9 
Type of Sponsor  Other [self financed ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr RAJALAXMI V  ACS Medical college and Hospital   First floor, Room no.12, Faculty of physiotherapy, Poonamallee high road, velappanchavadi, chennai 600077
Chennai
TAMIL NADU 
9176123939

rajalaxmiphysio@gmail.com 
Christy sopna S  East coast institute of medical sciences   Fourth floor, Room No.8 (exercise therapy lab), Department of physiotherapy, Paris Nagar, Moolakulam, puducherry- 605010
Pondicherry
PONDICHERRY 
7339626450

christysopna.jesus@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional ethics committee, ACS medical college hospital   Approved 
Institutional ethics committee, East coast institute of medical sciences   Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E668||Other obesity,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Circuit interval training(CIT)  Circuit Interval Training consists of Warm up, a set of exercises and an cool down exercise for 50 minutes given thrice in aweek for 16 weeks 
Comparator Agent  Conventional exercise   standard exercise consisting of basic exercise advice (150 minutes/week) 3 days in a week of continuous moderate intensity exercise session of walking at 50-60% Heart Rate Reserve (HRR)  
Intervention  High intensity intermittent training (HIIT)   High intensity intermittent training consists of Warm up, a set of exercises and an cool down exercise for 50 minutes given thrice in a week for 16 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Female 
Details  College girls diagnosed based on Rotterdam criteria & international guideline for the assessment and management of PCOS
College girls aged between 18 to 25
BMI 25-34.9Kg per meter square
Ferriman Gallwey score greater than or equal to 8
Subjects willing to participate in the study and able to do the exercise [12.13,14]
Sufficient English/tamil language to understand and complete the outcome tool [12.13,14]
 
 
ExclusionCriteria 
Details  Other causes of menstrual disturbances, hyperandrogenism, adrenal diseases and pregnancy
Known cardiovascular problems, uncontrolled hypertension or hypotension
Presence of neurological disease, orthopaedic illness, cardiopulmonary disease and musculoskeletal injuries
Subjects on anti-obesity medications
Known psychiatric illness
Inability to cooperate
Any other hormonal imbalances
physical ailments or injuries that limits exercise performance
concurrent treatments (insulin sensitizers as metformin and pioglitazone)
Drugs that affect gonadotropin or ovulation
 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
ANTHROPOMETRIC MEASUREMENTS
Body Mass Index(BMI)
Waist Hip Ratio(WHR)
Waist Height Ratio(WHtR)
BIOCHEMICAL PARAMETER
C- reactive protein
HOMA-IR
SHBG
Serum Follicle stimulating hormone (FSH)
Serum leutinizing hormone (LH)
WHOQOL-BREF questionnaire
 
At baseline - 1 st day
post test - 16 week
two time points 
 
Secondary Outcome  
Outcome  TimePoints 
Sick absenteeism
Hirsutism (Ferriman gallwey score)
MENSTRUAL SYMPTOMS
Menstrual regularity
Menstrual frequency, volume & flow
Dysmennorhoea – wong backer faces pain rating scale
Ovulation

 
At baseline - 1 st day
post test - 16 week
two time points 
 
Target Sample Size   Total Sample Size="225"
Sample Size from India="225" 
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   Phase 2 
Date of First Enrollment (India)   20/07/2025 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Polycystic ovary syndrome (PCOS) is a heterogeneous endocrine disorder distinguished by the manifestation of Ovarian cysts, anovulation and endocrine variations that Severely impact the life of a woman. According to the World health organization (WHO) 116 million women (4%-12%) are affected by PCOS worldwide in 2012, and in 2020, the ratio increased to 26%. Obesity is very common among PCOS women which is responsible for an increased risk of sub fecundity and infertility, so obese women show poorer reproductive outcomes regardless of the mode of conception and a higher body mass index. The prevalence of PCOS is more in the reproductive age group and with lifestyle modification there will be a predominant change in the reproductive , physical and mental well being. According to devipriya et al., The probable prevalence of  PCOS among college going girls in puducherry is 25.1% which should be identified and managed early so that the future complication can be prevented. .This study focuses on Primary prevention of  the symptoms of PCOS among college going obese girls.

 Need for the Study

·       WHO states that PCOS is an common hormonal condition that affects an estimated 8-13% of reproductive aged women, upto 70% of affected women remain undiagnosed worldwide. It usually starts during adolescence, but symptoms may fluctuate over time.

·       Lifestyle changes is the first line of management for PCOS

·       As PCOS starts early in adolescence age group primary prevention plays an important role in diagnosing, reducing the symptoms of PCOS and prevention of subfecundity and infertility.

·       Several studies have shown that weight loss of 5 to 10 % of total body weight in overweight women with PCOS with the help of good nutrition and exercise training can lead to a reduction of central fat deposition, reduced circulating insulin and androgen levels, improved insulin sensitivity and thereby restoring ovulation, improving menstrual cycles and cardiovascular disease risk factors.

Primary Objectives

       To analyse the effect of high intensity intermittent training (HIIT) on physical health , reproductive parameters and quality of life among obese college girls with PCOS.

       To analyse the effect of circuit interval training (CIT) on physical health , reproductive parameters and quality of life among obese college girls with PCOS.

       To analyse the effect of conventional exercise on physical health , reproductive parameters and quality of life among obese college girls with PCOS.

       To analyse the comparative effectiveness  of high intensity intermittent training(HIIT) and circuit interval training (CIT) over conventional exercise on physical health , reproductive parameters and quality of life among obese college girls with PCOS.

Secondary Objectives

       To evaluate the effect of structured exercise training on body composition

       To assess the changes in reproductive outcomes and menstrual irregularities

       To assess the effect of structured exercise trainings in quality of life

       To compare the adherence and sick absenteeism between the structured and conventional exercise groups 

Null Hypothesis

v  There is no significant effect of circuit interval training on physical, reproductive and quality of life among college girls with PCOS.

v  There is no significant effect of High intensity intermittent training on physical, reproductive and quality of life among college girls with PCOS.

v  There is no significant effect of conventional training on physical, reproductive and quality of life among college girls with PCOS.

Alternate Hypothesis

v  There is an significant effect of circuit interval training on physical, reproductive and quality of life among college girls with PCOS.

v  There is an significant effect of High intensity intermittent training on physical, reproductive and quality of life among college girls with PCOS.

v  There is an significant effect of conventional training on physical, reproductive and quality of life among college girls with PCOS.

NATIONAL SIGNIFICANCE

Polycystic Ovary Syndrome (PCOS) is one of the most common endocrine disorders among women of reproductive age, affecting approximately 6–20% globally, with increasing prevalence among adolescents and young adults. In India, rising rates of obesity among college-aged women have compounded the impact of PCOS, contributing to metabolic dysfunction, menstrual irregularities, and increased risk of infertility. The dual burden of obesity and PCOS during young adulthood presents a critical public health challenge with long-term implications for women’s reproductive, metabolic, and psychological health.

This study holds national significance as it addresses multiple pressing health concerns through a preventive, non-pharmacological intervention—structured physical exercise. Exercise has been demonstrated to improve insulin sensitivity, promote hormonal balance, reduce body mass index (BMI), and alleviate psychological symptoms such as anxiety and depression, which are frequently observed in women with PCOS. By focusing on college-going girls, the research targets a key developmental stage where health behaviors are formed and can be positively influenced for lifelong impact.

The outcomes of this research have the potential to inform national health strategies and programs such as the Fit India Movement, National Programme for Prevention and Control of Non-Communicable Diseases (NP-NCD), Rashtriya Kishor Swasthya Karyakram, and reproductive health education initiatives. Findings can contribute to the development of evidence-based physical activity guidelines tailored for young women with PCOS, potentially reducing reliance on pharmacological treatments and improving health outcomes in a cost-effective manner.

Moreover, addressing PCOS and obesity at the national level is aligned with broader goals related to women’s empowerment, gender equity in healthcare, and the reduction of non-communicable diseases. The integration of such findings into health promotion efforts within educational institutions may significantly enhance the physical and mental well-being of young women across the country.


 
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