| CTRI Number |
CTRI/2025/08/093646 [Registered on: 25/08/2025] Trial Registered Prospectively |
| Last Modified On: |
25/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding Period Health and Fitness in Indian Para-athletes |
|
Scientific Title of Study
|
Menstrual Cycle related Health and Self-perceived Fitness Components Across
the Phases among Indian Para-athletes |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chaitali Xrirama Joshi |
| Designation |
Postgraduate student |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Exercise And Sports Science, Manipal College of Health Professions, MAHE, Manipal, Karnataka
Udupi KARNATAKA 576104 India |
| Phone |
7038079758 |
| Fax |
|
| Email |
j.chaitali0802@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Tanugatri Majumder |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Exercise And Sports Science, Manipal College of Health Professions, MAHE, Manipal, Karnataka
Udupi KARNATAKA 576104 India |
| Phone |
6290891258 |
| Fax |
|
| Email |
tanugatri.majumder@manipal.edu |
|
Details of Contact Person Public Query
|
| Name |
Tanugatri Majumder |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Exercise And Sports Science, Manipal College of Health Professions, MAHE, Manipal, Karnataka
Udupi KARNATAKA 576104 India |
| Phone |
6290891258 |
| Fax |
|
| Email |
tanugatri.majumder@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Karnataka, India, 576104 |
|
|
Primary Sponsor
|
| Name |
Chaitali Xrirama Joshi |
| Address |
Department of Exercise And Sports Science, Manipal College of Health Professions, MAHE, Manipal, Karnataka, India , 576104 |
| 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 |
| Manjunatha LH |
Parishrama Divyang Sports Academy |
2303, 21st Cross Rd, K.R.Road, Banashankari Stage II, Banashankari, Bengaluru, Karnataka 560070 Bangalore KARNATAKA |
97392 75828
parishramasportsacademy23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 (Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Para-athletes |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1. Indian female para-athletes competing actively for the past 2 years in competitions recognized
by International Paralympic Committee (IPC)
2. Age: 18-35 years
3. Have access to internet, smartphone/laptop Able to read and comprehend basic English |
|
| ExclusionCriteria |
| Details |
1. Currently injured para-athletes
2. Visually impaired para-athletes
3. Intellectually impaired para-athletes |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Perceived fitness: self-reported fitness components across MC phases
2. Menstrual cycle characteristics: cycle length (days), symptom frequency |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/09/2025 |
| Date of Study Completion (India) |
08/11/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
08/11/2025 |
|
Estimated Duration of Trial
|
Years="0" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
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
|
This study aims to explore menstrual cycle related health
and self-perceived fitness components across different phases among Indian
female para-athletes. A cross-sectional design will be used with approximately
30 participants actively competing in para sports. Indian female para-athletes
aged 18 to 35 years who have been actively competing for at least the past two
years in competitions recognized by the International Paralympic Committee will
be recruited for the study. Participants must have access to the internet via a
smartphone or laptop and be able to read and understand basic English. Para
athletes who are currently injured, or those with visual impairment or
intellectual impairment, will be excluded from the study.
Data will be collected online through a structured
questionnaire distributed via Google Forms. Descriptive statistics and
inferential analysis will be performed using Microsoft Excel, R software and
Jamovi. The findings are expected to provide insights into menstrual health and
fitness perceptions of Indian para-athletes, which may support the development
of culturally sensitive training programs and athlete support strategies. |