| CTRI Number |
CTRI/2026/02/105041 [Registered on: 27/02/2026] Trial Registered Prospectively |
| Last Modified On: |
26/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
How Pilates improves heart health and daily life for women with Polycystic ovarian syndrome |
|
Scientific Title of Study
|
Effectiveness of Pilates on Cardiorespiratory fitness and quality of life among females with Polycystic Ovarian Syndrome |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Devika Vibhish |
| Designation |
postgraduate student |
| Affiliation |
Medical Trust Institute of Medical sciences, Irumpanam |
| Address |
Medical Trust Institute of Medical Sciences, Department of Physiotherapy, HOC Township, Backside Road, Irumpanam, Kerala, India
Medical Trust Institute of Medical Sciences, HOC Township, Backside Road, Irumpanam
Ernakulam
KERALA
682309
India |
| Phone |
8547108603 |
| Fax |
|
| Email |
vibhishdevika@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Princy Mathew |
| Designation |
Professor |
| Affiliation |
Medical Trust Institute of Medical Sciences, Irumpanam |
| Address |
Medical Trust Institute of Medical Sciences, Department of Physiotherapy, HOC Township, Backside Road, Irumpanam, Kerala, India
Medical Trust Institute of Medical Sciences, HOC Township, Backside Road, Irumpanam
Ernakulam
KERALA
682309
India |
| Phone |
9446582509 |
| Fax |
|
| Email |
princybruces@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anila Paul |
| Designation |
Professor |
| Affiliation |
Medical Trust Institute of Medical Sciences, Irumpanam |
| Address |
Medical Trust Institute of Sciences, Department of Physiotherapy,HOC Township, Backside Road, Irumpanam, Kerala, India
Medical Trust Institute of Medical Sciences, HOC Township, Backside Road, Irumpanam
Ernakulam
KERALA
682309
India |
| Phone |
04842843502 |
| Fax |
|
| Email |
mtimsbpt@medicaltrusthospital.in |
|
|
Source of Monetary or Material Support
|
| Medical Trust Institute of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
Medical Trust Institute of Medical Sciences |
| Address |
Medical Trust Institute of Medical Sciences, HOC Township, Backside Road, Irumpanam, Kerala, 682309, India |
| Type of Sponsor |
Research institution |
|
|
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 Princy Mathew |
Medical Trust Institute of Medical Sciences |
Department of Physiotherapy,HOC Township, Backside Road, Irumpanam, 682309
Ernakulam
KERALA |
04842843502
princybruces@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Medical Trust Hospital, Kochi 682016 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E282||Polycystic ovarian syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Diaphragmatic breathing exercise |
12 weeks, 10-15 minutes, 3 times per week |
| Intervention |
Pilates exercise |
12 weeks, 40-50 minutes,3 times per week |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
1. Females who are recently (6months -1year) diagnosed for PCOS by Rotterdam criteria
2. Females of age group 18-30
3. Females who are normal weight with BMI 17.50-22.99 (ASIAN CLASSIFICATION) |
|
| ExclusionCriteria |
| Details |
1. Females with systemic diseases
2. Female who are pregnant and lactating women
3. Females who are involved in any athletic or leisure activities
4. Females of BMI less than 17.50 and more than 22.99 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Cardiorespiratory fitness (VO2max) |
Baseline and after 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| SF36 Questionnaire |
Baseline and after 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
20/04/2026 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 study examines 30 females with PCOS who have low cardiorespiratory fitness and poor quality of life. They undergo 12 weeks of Pilates exercises. The study aims to assess Pilates’ effectiveness on their cardiorespiratory fitness and quality of life. |