| CTRI Number |
CTRI/2026/02/104936 [Registered on: 26/02/2026] Trial Registered Prospectively |
| Last Modified On: |
24/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA)
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Tailored Exercise and Counseling on Body Composition and Body Image in Young Women with Polycystic Ovary Syndrome |
|
Scientific Title of Study
|
Effects of phenotype tailored exercise and cognitive behavioural therapy on body composition and body image satisfaction among young adults with PCOS: a feasibility randomized controlled trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
RAMYA A |
| Designation |
PG student |
| Affiliation |
SRM College Of Physiotherapy |
| Address |
Department of Physiotherapy
SRM College of Physiotherapy
SRM Institute of Science and Technology Kattankulathur
Tamil Nadu 603203 India
Kancheepuram
TAMIL NADU
603202
India |
| Phone |
9361276404 |
| Fax |
|
| Email |
ra0197@srmist.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M ANBUPRIYA |
| Designation |
Associate professor |
| Affiliation |
SRM College Of Physiotherapy |
| Address |
Room no PT14
staff room
SRM College Of Physiotherapy
Kattankulathur
Kancheepuram
TAMIL NADU
603202
India |
| Phone |
9841549219 |
| Fax |
|
| Email |
anbuprim@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr M ANBUPRIYA |
| Designation |
Associate professor |
| Affiliation |
SRM College Of Physiotherapy |
| Address |
Room no PT14
staff room
SRM College Of Physiotherapy
Kattankulathur
Kancheepuram
TAMIL NADU
603202
India |
| Phone |
9841549219 |
| Fax |
|
| Email |
anbuprim@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| Self-funded study.
SRM College of Physiotherapy, SRM Institute of Science and Technology (SRMIST), Kattankulathur, Chengalpattu District, Tamil Nadu – 603203, India. |
|
|
Primary Sponsor
|
| Name |
SRM Institute of Science and Technology |
| Address |
Department of Physiotherapy,
SRM College of Physiotherapy,
SRM Institute of Science and Technology, Kattankulathur, Chengalpattu District,
Tamil Nadu – 603203, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 M Anbupriya |
SRM College Of Physiotherapy |
Staff room PT14
SRM College of Physiotherapy
SRM Institute of Science and Technology Kattankulathur Chengalpattu District
Tamil Nadu 603203 India
Kancheepuram
TAMIL NADU |
9841549219
anbuprim@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM MEDICAL COLLEGE AND RESEARCH CENTRE, Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E282||Polycystic ovarian syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Exercise Control Group |
Participants in the control group will receive conventional aerobic and strengthening exercises for ten weeks. Sessions will be conducted five days per week for sixty minutes. No structured cognitive behavioural therapy will be provided. |
| Intervention |
phenotype A Exercise plus CBT |
Participants with phenotype A PCOS will receive structured aerobic exercise resistance training and supervised cognitive behavioural therapy. Exercise sessions will be conducted five days per week for ten weeks. Each session will last sixty minutes including warm up aerobic training strengthening exercises and cool down. Cognitive behavioural therapy will be given once weekly focusing on body image thoughts emotional regulation and lifestyle adherence. |
| Intervention |
phenotype B and D exercise plus CBT |
Participants with phenotype B and D PCOS will receive phenotype specific aerobic and strengthening exercises along with structured cognitive behavioural therapy. Exercise will be given five days per week for ten weeks with each session lasting sixty minutes. Cognitive behavioural therapy will be provided once weekly addressing stress management body image concerns and behavioural modification. |
| Intervention |
Phenotype C exercise plus CBT |
Participants with phenotype C PCOS will undergo structured aerobic and resistance exercise tailored to metabolic needs along with supervised cognitive behavioural therapy. Exercise will be performed five days per week for ten weeks with each session lasting sixty minutes. Weekly cognitive behavioural therapy sessions will focus on psychological wellbeing body image and lifestyle compliance. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
Women aged 18 to 25 years diagnosed with PCOS based on Rotterdam criteria. Willing to participate and provide informed consent. Able to participate in exercise program. |
|
| ExclusionCriteria |
| Details |
Women with other endocrine disorders such as thyroid dysfunction or Cushing syndrome. Pregnancy or lactation. Severe psychiatric illness. Contraindication to exercise. Currently undergoing other structured exercise or psychological therapy program. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
Body Composition Analyser,Body Appreciation Scale (BAS-2)
|
Base line week 1, mid week 5 and post intervention week 10
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Six Minutes Walk Test (6MWT)
Perceived Stress Scale
|
Base line week 1, mid week 5 and post intervention week 10 |
|
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Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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)
|
21/03/2026 |
| 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="2"
Days="10" |
|
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
|
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Brief Summary
|
This study aims to evaluate the effects of phenotype tailored exercise and cognitive behavioural therapy on body composition and body image satisfaction among young adults with polycystic ovary syndrome. Polycystic ovary syndrome is associated with metabolic disturbances psychological distress and body image dissatisfaction. Seventy four participants aged 18 to 25 years diagnosed based on Rotterdam criteria will be recruited and randomly allocated into three experimental groups and one control group. Experimental groups will receive phenotype specific structured exercise program along with cognitive behavioural therapy for ten weeks. The control group will receive conventional exercise education. Outcome measures include body composition parameters six minute walk test Body Appreciation scale and perceived stress scale. Assessments will be conducted at baseline week one mid intervention week five and post intervention week ten. The study aims to provide a holistic management approach addressing both physical and psychological health in women with polycystic ovary syndrome |