| CTRI Number |
CTRI/2024/11/076998 [Registered on: 19/11/2024] Trial Registered Prospectively |
| Last Modified On: |
26/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Longitudinal Prospective |
| Study Design |
Other |
|
Public Title of Study
|
Correlation of physical activity and lifestyle behavior with key factors
among the late adolescent to early adulthood PCOS |
|
Scientific Title of Study
|
Association of physical activity and lifestyle behavior with key variables among the late adolescent to early adulthood polycystic ovarian syndrome: A prospective longitudinal 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 |
Krathi Shivachandra |
| Designation |
PG student |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
Kasturba Medical College, Department of Physiotherapy, Bejai, Mangalore
Dakshina Kannada
Karnataka
575004
India
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
7411802401 |
| Fax |
|
| Email |
krathijuvia@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kuldeep Deka |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
Kasturba Medical College, Department of Physiotherapy, Bejai, Mangalore
Dakshina Kannada
Karnataka
575004
India
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
9954676301 |
| Fax |
|
| Email |
kuldeep.deka@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kuldeep Deka |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
Kasturba Medical College, Department of Physiotherapy, Bejai, Mangalore
Dakshina Kannada
Karnataka
575004
India
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
9954676301 |
| Fax |
|
| Email |
kuldeep.deka@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Department of Physiotherapy, Bejai, Mangalore
Dakshina Kannada
Karnataka
575004
India |
|
|
Primary Sponsor
|
| Name |
Krathi Shivachandra |
| Address |
Kasturba Medical College, Department of Physiotherapy, Bejai, Mangalore
Dakshina Kannada
KARNATAKA
575004 India |
| Type of Sponsor |
Other [Self sponsored ] |
|
|
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 Krathi Shivachandra |
KMC Hospital and Govt. Ladygoschen Hospital |
KMC Hospital, Nanddigudda Road, Attavar -575002
Govt. Ladygoschen Hospital, Maidan Road, Bhavathi, Hampankatta, Mangalore -575001
Dakshina Kannada
Karnataka
Dakshina Kannada
KARNATAKA |
7411802401
krathijuvia@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, KMC, Mangalore. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E348||Other specified endocrine disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
34.00 Year(s) |
| Gender |
Female |
| Details |
1)Subject in the age group of late adolescence to early adulthood (18-34 years).
2)Diagnosis of polycystic ovarian syndrome within 6 months. |
|
| ExclusionCriteria |
| Details |
1)History of musculoskeletal or other physical symptoms that would otherwise limit exercise performance.
2)Pregnancy, lactation, or change in weight in the past one year.
3)Presence of other disease or a different endocrine disorder.
4)Subjects with a known history of cardiovascular, hepatic or pulmonary disease.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Physical Fitness Test, MfG scoring, WaLIDD, lifestyle behavior assessment
|
baseline and at 3 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| IPAQ-SF |
baseline & each month |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
01/02/2025 |
| 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="1"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
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)
|
Considering the numerous literatures on the beneficial impact of physical exercise, dietary and lifestyle measures on management of symptoms for PCOS, knowledge of current physical activity type and intensity and lifestyle behavior pattern may help the clinicians to develop an effective non-pharmacological tailored based management strategy for insulin sensitivity and improvement in androgenic functions for PCOS afflicted women. Objective of the study is to evaluate the factors- demographic, physical activity and lifestyle behavior characteristics influencing the disease specific variability.
Protocol Given would include- duration of protocol- every 3 months |