| CTRI Number |
CTRI/2024/01/061294 [Registered on: 09/01/2024] Trial Registered Prospectively |
| Last Modified On: |
31/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of young girls with polycystic ovarian syndromes cardio-respiratory fitness |
|
Scientific Title of Study
|
Assessment of cardio-respiratory fitness in young females with polycystic ovary 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 |
Janavi Sanghani |
| Designation |
PG Student |
| Affiliation |
Collage Of Physiotherapy, Sumandeep Vidyapeeth Deemed To Be University |
| Address |
PG Classroom, On ground Floor, Collage Of Physiotherapy, Sumandeep Vidyapeeth Deemed To Be University, Pipariya, Waghodiya, Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
6353679188 |
| Fax |
|
| Email |
janvisanghani85@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kalpesh Satani |
| Designation |
Professor |
| Affiliation |
Collage Of Physiotherapy, Sumandeep Vidyapeeth Deemed To Be University |
| Address |
Staffroom, On ground Floor, Collage Of Physiotherapy, Sumandeep Vidyapeeth Deemed To Be University, Pipariya, Waghodiya, Vadodara.
Vadodara
GUJARAT
391760
India |
| Phone |
9979483324 |
| Fax |
|
| Email |
kalpesh.cop@sumandeepvidyapeethdu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kalpesh Satani |
| Designation |
Professor |
| Affiliation |
Collage Of Physiotherapy, Sumandeep Vidyapeeth Deemed To Be University |
| Address |
Staffroom, On ground Floor, Collage Of Physiotherapy, Sumandeep Vidyapeeth Deemed To Be University, Pipariya, Waghodiya, Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9979483324 |
| Fax |
|
| Email |
kalpesh.cop@sumandeepvidyapeethdu.edu.in |
|
|
Source of Monetary or Material Support
|
| Various constituent Institutes of Sumanddep Vidyapeeth Deemed to be University |
|
|
Primary Sponsor
|
| Name |
Janavi Sanghani |
| Address |
PG Classroom, On ground Floor, Collage Of Physiotherapy,
Sumandeep Vidyapeeth Deemed To Be University, Pipariya,
Waghodiya, Vadodara, Gujarat-391760 |
| Type of Sponsor |
Other [Other (Self Funded)] |
|
|
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 Janavi Sanghani |
various constituent institutes of Sumandeep Vidyapeeth Deemed to be University |
Collage Of Physiotherapy,
Sumandeep Vidyapeeth Deemed To Be University, Pipariya,
Waghodiya, Vadodara, Gujarat-391760
Vadodara
GUJARAT |
6353679188
janvisanghani85@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep Vidyapeeth Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E889||Metabolic disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
24.00 Year(s) |
| Gender |
Female |
| Details |
Diagnosed young females with PCOS.
Age: 18-24 year
Subject should be able to read and write English. |
|
| ExclusionCriteria |
| Details |
Any neurological cardio respiratory musculoskeletal problems that hinders with the performance of individual.
Individuals with other androgen excess disorders such as non-classical congenital adrenal hyperplasia.
Pregnancy. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Maximum oxygen consumption (VO2max) |
Maximum oxygen consumption (VO2max) will be calculated after conduction of the test. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
Final Enrollment numbers achieved (Total)= "37"
Final Enrollment numbers achieved (India)="37" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
14/01/2024 |
| Date of Study Completion (India) |
22/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
22/03/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| 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
|
introduction Polycystic ovary syndrome (PCOS) is a common hormonal condition that affects an reproductive aged women. The effect of PCOS on the cardio-respiratory system is still unknown. Consequently, there is a strong need to increase the understanding of involvement of cardio-respiratory system in PCOS. method Maximal aerobic capacity (VO2max) is a measure of cardio-respiratory fitness and is a powerful independent predictor of functional capacity. All the participants perform queen’s college step test and heart rate at the end of the test will be used for the measurment of VO2max. Measurement of maximal oxygen consumption (VO2max) The subject will be asked to rest in a supine posture. The resting heart rate and the blood pressure will be measured. Test protocol will be explained to the subject and demonstrated the same. The stepping protocol will be followed as: both feet on the ground, first foot on the step, step-up with the second foot on the step, both foot on the step, first foot back on the ground, and finally the second foot on the ground. The subject will be asked to perform the test for 3 min. The subject will be asked to stop immediately on completion of 3 minutes. At the end of the test, the subject has to remain standing for the measurement of Heart rate. The number of heart beats between the 5th and 20th second after the completion of the test will be noted down. And from the heart rate vo2max will be calculated with the use of following formula. VO2max (ml/kg/min) = 65.81 - [0.1847 x heart rate (bpm)] |