| CTRI Number |
CTRI/2024/09/074303 [Registered on: 24/09/2024] Trial Registered Prospectively |
| Last Modified On: |
11/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Relationship between body measures with fatigue among PCOS women |
|
Scientific Title of Study
|
Association Of Anthropometric Measures with Fatigue among women 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 |
Gunjan Nagpal |
| Designation |
Post Graduate Student (MPT) |
| Affiliation |
Chhatrapati Shahu ji Maharaj University, Kanpur |
| Address |
Department of Physiotherapy, School of Health Sciences, Chhatrapati Shahu ji Maharaj University, Kanpur
Kanpur Nagar
UTTAR PRADESH
208024
India |
| Phone |
07379809571 |
| Fax |
|
| Email |
gunjan6459@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aakanksha Bajpai PT |
| Designation |
Assistant Professor |
| Affiliation |
Chhatrapati Shahu ji Maharaj University, Kanpur |
| Address |
Room No 127, Department of Physiotherapy, School of Health Sciences, Chhatrapati Shahu ji Maharaj University, Kanpur
Kanpur Nagar
UTTAR PRADESH
208024
India |
| Phone |
7524853949 |
| Fax |
|
| Email |
akankshabajpai@csjmu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Gunjan Nagpal |
| Designation |
Student |
| Affiliation |
Chhatrapati Shahu ji Maharaj University, Kanpur |
| Address |
Department of Physiotherapy, School of Health Sciences, Chhatrapati Shahu ji Maharaj University, Kanpur
Kanpur Nagar
UTTAR PRADESH
208024
India |
| Phone |
07379809571 |
| Fax |
|
| Email |
gunjan6459@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, School Of Health Sciences, Chhatrapati Shahu Ji Maharaj University, Kanpur, Uttar Pradesh, India
Pin code- 208024 |
|
|
Primary Sponsor
|
| Name |
Gunjan Nagpal |
| Address |
Department of Physiotherapy, School of Health Sciences, Chhatrapati Shahu Ji Maharaj University, Kanpur, Uttar Pradesh, India
Pin Code- 208024 |
| Type of Sponsor |
Other [Self Finance] |
|
|
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 Aakanksha Bajpai PT |
Chhatrapati Shahu ji Maharaj University, Kanpur |
Room no 127, Department of Physiotherapy, School of Health Sciences, Chhatrapati Shahu Ji Maharaj University, Kanpur, Uttar Pradesh, India
Pin code- 208024
Kanpur Nagar
UTTAR PRADESH |
7524853949
akankshabajpai@csjmu.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Chhatrapati Shahu ji Maharaj University, Kanpur |
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 |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
34.00 Year(s) |
| Gender |
Female |
| Details |
Women aged 18 to 34 years, clinically diagnosed PCOs, confirmed diagnosis of PCOS since last one-year, stable vitals, menstrual cycle more than 35 days apart or less than 8 menses a year, participants who are willing to participate |
|
| ExclusionCriteria |
| Details |
1 Presence of any Comorbidities like Diabetes Mellitus, Hypertension, Thyroid.
2 Any other documented history of cardiopulmonary disorders, musculoskeltal disorders, neurological disorders.
3 Any person with prescribed medication that will affect the outcome of the study will be
excluded.
4 Pregnant and lactating womens.
5 Athlete females |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Fatigue (Fatigue Severity Scale) (FSS)
Anthropometric Measures
ï¬ Body Mass Index (BMI)
ï¬ Waist hip ratio (WHR)
ï¬ Waist height ratio (WHtR)
ï¬ Waist circumference (WC)
ï¬ Calf circumference (CC)
ï¬ Skin Fold Thickness (Biceps, Triceps,subscapular,suprailiac ) |
one time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| sleep, quality of life |
one time |
|
|
Target Sample Size
|
Total Sample Size="152"
Sample Size from India="152"
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)
|
30/09/2024 |
| 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="2"
Months="0"
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 - YES
- What data in particular will be shared?
Response (Others) -
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 20-09-2024 and end date provided 20-09-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
The purpose of the study is to identify the association between anthropometric measures and fatigue in women with pcos. by investigating we aim to improve the management of fatigue in pcos and leading to a better quality of life for women. The objective of the study is to study the anthropometric profile in pcos women, to examine the fatigue level using fatigue severity scale, to analyse the correlation between anthropometric profile and fatigue level. The methodology of the study reveals the study is cross sectional type of study, conducted in Department of physiotherapy, School of Health Science, Chhattrapati Shahu Ji Maharaj University with 2 years of study duration, Women aged (18-34) years who have received a clinical diagnosis of PCOS have been choosen as study poppulation, a purposive sampling method and a sample size of 152 has been selected Outcome measures like Anthropometric Measures, Body Mass Index (BMI), l Waist hip ratio (WHR), Waist height ratio (WHtR), Waist circumference (WC), Calf circumference (CC), Skin Fold Thickness (Biceps, Triceps, subscapular, suprailiac) and fatigue severity scale. Anthropometric measures as independent and fatigue is considerd as dependent scale. |