| CTRI Number |
CTRI/2025/04/085009 [Registered on: 16/04/2025] Trial Registered Prospectively |
| Last Modified On: |
11/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparative Study on quality of sleep Physical Performance and Fatigue in Working and Non Working Females with Polycystic Ovary Syndrome (PCOS) so after comparing we can find out is there a same treatment to be followed among both groups or need changes |
|
Scientific Title of Study
|
Comparison of Sleep Quality Physical Performance and Fatigue among working and non working females with PCOS |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aamna Khan |
| Designation |
student |
| Affiliation |
Jamia Hamdard University |
| Address |
Department of physiotherapy 5th floor Central library Jamia Hamdard Mehrauli Badarpur Rd near Batra Hospital Block D
Hamdard Nagar New Delhi
New Delhi
DELHI
110062
India |
| Phone |
8840815616 |
| Fax |
|
| Email |
aamnakhanspn@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Sohrab Ahmad Khan |
| Designation |
Head Of The Department Of Physiotherapy |
| Affiliation |
Jamia Hamdard University |
| Address |
Department of physiotherapy 5th floor Central library Jamia Hamdard Mehrauli Badarpur Rd near Batra Hospital Block D
Hamdard Nagar New Delhi
New Delhi
DELHI
110062
India |
| Phone |
8802648164 |
| Fax |
|
| Email |
sakhan_ahs@jamiahamdard.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Sohrab Ahmad Khan |
| Designation |
Head Of The Department Of Physiotherapy |
| Affiliation |
Jamia Hamdard University |
| Address |
Department of physiotherapy 5th floor Central library Jamia Hamdard Mehrauli Badarpur Rd near Batra Hospital Block D
Hamdard Nagar New Delhi
New Delhi
DELHI
110062
India |
| Phone |
8802648164 |
| Fax |
|
| Email |
sakhan_ahs@jamiahamdard.ac.in |
|
|
Source of Monetary or Material Support
|
| Gate number 6 Rehabilitation Center Jamia Hamdard New Delhi
110062 |
|
|
Primary Sponsor
|
| Name |
Aamna Khan |
| Address |
Department Of Physiotherapy 5th Floor central library Jamia Hamdard Mehrauli Badarpur Rd near Batra Hospital Block D
Hamdard Nagar New Delhi
110062 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Aamna Khan |
Majeedia Unani Hospital |
Department of Obstetrics and Gynecology Ground floor, Block D Hamdard Nagar New Delhi Delhi 110062
South
DELHI |
8840815616
aamnakhanspn@gmail.com |
| Aamna Khan |
Rehabilitation centre |
gate number 6 Rehabilitation Centre room number 9 Jamia Hamdard New Delhi
South
DELHI |
8840815616
aamnakhanspn@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jamia Hamdard Institutional Ethics Committee |
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 |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Participant will be diagnosed with PCOS on the basis of Rotterdam criteria
Employment Status Working women: women who are working at least 8 hours out of the house on regular basis Or working 5 hours a week for at least 1 year Non-working women Must not be engaged in any paid employment during the study period including homemakers or unemployed women
|
|
| ExclusionCriteria |
| Details |
Participants will be excluded if they have immune problems metabolic or cardiovascular diseases infections trauma or significant social issues Pregnant women or those who have been pregnant in the last six months as well as lactating mothers will also be excluded Women with inconsistent employment status recent job changes within the last three months will not be considered to ensure stability Those taking medications that affect sleep fatigue or physical fitness except prescribed treatments for PCOS will be excluded Additionally participants with depression anxiety disorders or bipolar disorder inconsistent use of birth control recent surgeries or hospitalization or involvement in intense physical training will be ineligible |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Sleep Quality assessed using Pittsburgh Sleep Quality Index PSQI
Fatigue Levels assessed using Multidimensional Fatigue Inventory MFI 20 Physical Performance assessed using 1 minute sit up test 6 minute walk test Broad jump test and Sit and Reach test
|
Baseline outcome measures will be taken |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="134"
Sample Size from India="134"
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)
|
20/05/2025 |
| 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="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
|
This study is designed to compare sleep quality physical performance and fatigue levels between working and non working females diagnosed with polycystic ovary syndrome PCOS It is a common endocrine disorder among women of reproductive age often associated with metabolic psychological and physical health complications Occupational status may play a role in influencing these factors but limited research has explored its impact on sleep fatigue and physical capabilities in PCOS affected individuals To assess sleep quality the Pittsburgh Sleep Quality Index PSQI will be utilized which measures various components of sleep including duration, disturbances latency and overall restfulness Fatigue levels will be evaluated using the Multidimensional Fatigue Inventory20 MFI 20 which provides insights into general fatigue physical fatigue reduced activity reduced motivation and mental fatigue Physical performance will be objectively assessed using four standardized tests the 1 minute sit up test measuring core muscular endurance the 6-minute walk test assessing aerobic endurance and functional capacity the broad jump test evaluating lower body explosive strength and the sit and reach test determining flexibility particularly in the lower back and hamstrings By comparing these parameters between working and non working women with PCOS this study aims to determine whether occupational status has a significant impact on physical fitness fatigue and sleep quality The findings could contribute to tailored interventions for improving the health and well being of women with PCOS particularly in relation to workplace stress sedentary behavior and lifestyle modifications |