CTRI

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CTRI Number

CTRI/2025/11/097908 [Registered on: 24/11/2025] Trial Registered Prospectively

Last Modified On:

10/07/2026

Post Graduate Thesis

Yes

Type of Trial

Observational

Type of Study

Qualitative study

Study Design

Other

Public Title of Study

What helps and what doesn’t when teen girls with PCOS try to stay active during physical activity

Scientific Title of Study

Exploring challenges and supports of adherence to physical activity in adolescent polycystic ovary syndrome:A Qualitative study

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Stelvin Alisha DAlmeida
Designation	Postgraduate Student (MPT)
Affiliation	Yenepoya Physiotherapy College, Yenepoya (Deemed to be University), Naringana, Mangalore, Dakshina Kannada, Karnataka – 575018, India
Address	Yenepoya Physiotherapy College, Department Of Physiotherapy College 7th floor, room no. 703 Naringana campus, Mangalore Dakshina Kannada Dakshina Kannada KARNATAKA 575018 India
Phone	9632975498
Fax
Email	stelvinalisha06@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Asir John Samuel
Designation	Additional Professor
Affiliation	Yenepoya Physiotherapy College
Address	Yenepoya Physiotherapy College, Department Of Physiotherapy College 7th floor, room no. 703 Naringana campus, Mangalore Dakshina Kannada Dakshina Kannada KARNATAKA 575018 India
Phone	8059930222
Fax
Email	asirjohnsamuel@yenepoya.edu.in

Details of Contact Person
Public Query

Name	Dr Asir John Samuel
Designation	Additional Professor
Affiliation	Yenepoya Physiotherapy College
Address	Department of Physiotherapy – Pediatrics Division, Room No. 703, 7th Floor, Yenepoya Physiotherapy College, Yenepoya (Deemed to be University), University Road, Naringana Campus, Deralakatte, Mangalore, Dakshina Kannada District, Karnataka – 575018, India Dakshina Kannada KARNATAKA 575018 India
Phone	8059930222
Fax
Email	asirjohnsamuel@yenepoya.edu.in

Source of Monetary or Material Support

Yenepoya university (deemed to be university) Yenapoya Physiotherapy College, Deralakatte, Mangalore , Dakshina kannada, karnataka, India 575018

Primary Sponsor

Name	Stelvin Alisha DAlmeida
Address	Yenepoya Physiotherapy College University road, Deralakatte Mangaluru - 575018
Type of Sponsor	Other [Self]

Details of Secondary Sponsor

Name	Address
Nil	Nil

Countries of Recruitment

India

Sites of Study

No of Sites = 3
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Stelvin Alisha Dalmeida	Yenapoya Ayurveda College	Yenepoya Ayurveda College 1st floor 105 room no.Naringana Campus, Deralakkatte(Post), Mangaluru, Karnataka, India- 575018 Dakshina Kannada KARNATAKA	9632975498 stelvinalisha06@gmail.com
Stelvin Alisha Dalmeida	Yenapoya Physiotherapy College	Yenepoya Physiotherapy College 6th floor 603 room no. Naringana campus, Deralakkatte(Post), Mangaluru, Karnataka, India- 575018 Dakshina Kannada KARNATAKA	9632975498 stelvinalisha06@gmail.com
Stelvin Alisha Dalmeida	Yenapoya School	NH 17, Jeppina Mogaru 1st floor sports room Mangalore, Karnataka, India 575009 Dakshina Kannada KARNATAKA	9632975498 stelvinalisha06@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Yenepoya Ethics Committe 3	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: E282\|\|Polycystic ovarian syndrome,

Intervention / Comparator Agent

Type	Name	Details
Intervention	NIL	NIL

Inclusion Criteria

Age From	13.00 Year(s)
Age To	17.00 Year(s)
Gender	Female
Details	Adolescents diagnosed PCOS between the age group of 13 to 17 years. Confirm diagnosed of PCOS by health worker. Adolescents who are currently active

ExclusionCriteria

Details

Adolescent who are not physically active
Who can not communicate effectively
Severe psychological condition
Recent surgery (abdominal, pelvic)
Severe comorbidities
Any injuries that limit physical activities.

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
Semi-structured Interview Question	One Time Interview Session lasting 30 to 45 minutes conducted during data collection

Secondary Outcome

Outcome	TimePoints
NIL	NIL

Target Sample Size

Total Sample Size="15"
Sample Size from India="15"
Final Enrollment numbers achieved (Total)= "15"
Final Enrollment numbers achieved (India)="15"

Phase of Trial

N/A

Date of First Enrollment (India)

10/12/2025

Date of Study Completion (India)

04/07/2026

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

04/07/2026

Estimated Duration of Trial

Years="1"
Months="6"
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
Modification(s)

This qualitative research project intends to investigate in depth the obstacles and supports that influence physical activity adherence among teenagers with polycystic ovarian syndrome (PCOS). The study will include 10 to 19-year-olds who have been clinically diagnosed with PCOS and are actively physically active. Using a phenomenological design, data will be collected via face-to-face or telephone interviews with a semi-structured interview guide. The interviews will intend to explore teenagers’ lived experiences, including the psychological, social, and environmental elements that influence their motivation and ability to participate in regular physical activity.

All interviews will be audio recorded, transcribed, and evaluated thematically according to Braun and Clarke’s framework. The findings are intended to help healthcare professionals, educators, and caregivers create more effective and empathic support programs for adolescent girls with PCOS. The study’s findings will be communicated through academic presentations, conferences, and possible publication in peer-reviewed publications.