| CTRI Number |
CTRI/2024/09/073558 [Registered on: 06/09/2024] Trial Registered Prospectively |
| Last Modified On: |
05/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
|
| Study Design |
Other |
|
Public Title of Study
|
PCOS effect on aerobic capacity |
|
Scientific Title of Study
|
Effect Of PCOS On Aerobic Capacity Among Female Athletes In Swimming |
| Trial Acronym |
Poly cystic ovarian syndrome (PCOS) |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Janwi Singh |
| Designation |
PG Student |
| Affiliation |
Banarsidas Chandiwala Institute Of Physiotherapy |
| Address |
Banarsidas Chandiwala Institute of Physiotherapy, Chandiwala Estate, Maa Anandmayee Marg, Kalkaji, New Delhi 110019
South
DELHI
110019
India |
| Phone |
8507986990 |
| Fax |
|
| Email |
janwisingh1209@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr C S Ram |
| Designation |
Director |
| Affiliation |
Banarsidas Chandiwala Institute Of Physiotherapy |
| Address |
Banarsidas Chandiwala Insitute of Physiotherapy, Chandiwala Estate, , Ma Anandmayee Marg, Kalkaji, New Delhi, Delhi 110019
South
DELHI
110019
India |
| Phone |
9811297680 |
| Fax |
|
| Email |
director@bcip.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Janwi Singh |
| Designation |
PG Student |
| Affiliation |
Banarsidas Chandiwala Institute Of Physiotherapy |
| Address |
Banarsidas Chandiwala Insitute of Physiotherapy, Chandiwala Estate, Ma Anandmayee Marg, Kalkaji, New Delhi, Delhi 110019
South
DELHI
110019
India |
| Phone |
8507986990 |
| Fax |
|
| Email |
janwisingh1209@gmail.com |
|
|
Source of Monetary or Material Support
|
| Siri Fort Sports Complex, Siri Fort Institutional Area, Siri Fort, New Delhi, Delhi 110049 |
|
|
Primary Sponsor
|
| Name |
Janwi Singh |
| Address |
Banarsidas Chandiwala Institute of Physiotherapy, Chandiwala Estate, Ma Anandmayee Marg, Kalkaji, New Delhi, Delhi 110019 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Rajesh Kumar |
Siri Fort Sports Complex |
Siri Fort Institutional Area, Siri Fort, New Delhi, Delhi 110049
South
DELHI |
9311090556
krajeshh83@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Banarsidas Chandiwala Institute of Physiotherapy |
Approved |
| BANARSIDAS CHANDIWALAINSTITUTE OF PHYSIOTHERAPY-ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
PCOS |
Comparison of aerobic capacity in athletes with PCOS and athlete without PCOS |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Athlete training period -5 years
BMI- 18.5-24.9
Gender- Female Athletes
Diagnosed case of PCOS
|
|
| ExclusionCriteria |
| Details |
Individual not willing to participate in study.
History of neurological disease as explained by athlete.
Pregnancy.
Any Metabolic disease ( DM, Thyroid etc.) as explained by athlete.
History of cardiovascular disease as explained by athlete.
Recent lower limb injury (6 months) as explained by athlete |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
significant effect of PCOS on aerobic capacity among female athletes in swimmers.
|
1 day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| positive effect on fitness level and mental well being of athlete |
1 day |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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)
|
19/09/2024 |
| 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="0"
Days="1" |
|
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 polycystic ovary syndrome PCOS is conventionally defined as a combination of hyperandrogenism (hirsutism and acne) and anovulation (oligomenorrhea, infertility, and dysfunctional uterine bleeding) with polycystic ovaries. Ultrasound it is the main gynecological endocrinopathy of reproductive age, affecting 6% - 10% of women in menacme. It is the most common cause of infertility due to anovulation. Dermatological clinical manifestations of hyperandrogenism include: hirsutism, acne, seborrhea, alopecia and, in severe cases, signs of virilization Insulin resistance is considered to be a risk factor for coronary heart disease as it is associated with impaired glucose tolerance and type 2 DM (Reaven, 1988), hypertension (Ferrannini et al., 1987), abdominal obesity and adverse lipid profiles (Orchard et al., 1983), all features of the so-called ‘metabolic syndrome X’. Retrospective studies suggest that there is an association between PCOS and cardiovascular disease. The purpose of training programs in swimming is to produce metabolic, physiological and psychological changes that allow swimmers to perform better in competitions. In swimming, as well as in other sports, aerobic endurance is one of the most important components of the physical fitness of swimmers, while VO2max represents the most objective measure for its assessment |