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CTRI Number  CTRI/2025/09/095311 [Registered on: 23/09/2025] Trial Registered Prospectively
Last Modified On: 22/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Making and testing a Questionnaire to Check Knowledge of healthcare professionals about Female Athlete Triad and relative Energy deficiency in Sport 
Scientific Title of Study   Development And Validation Of A Questionnaire To Assess Knowledge Of Female Athlete Triad And Relative Energy Deficiency In Sport Among Healthcare Professionals 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shivam Soni 
Designation  Post Graduate Student  
Affiliation  College of Physiotherapy, Pt. B. D. Sharma, PGIMS Rohtak, Haryana 124001 
Address  Physiotherapy Department, E-Block, College of Physiotherapy, PGIMS ROHTAK, Haryana 124001

Rohtak
HARYANA
124001
India 
Phone  09253923740  
Fax    
Email  drshivamsoni2704@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Poonam Dhankher 
Designation  Associate Professor 
Affiliation  College of Physiotherapy, Pt. B. D. Sharma, PGIMS Rohtak, Haryana 124001 
Address  Physiotherapy Department, Faculty Room, E-Block, College of Physiotherapy, PGIMS ROHTAK, Haryana 124001

Rohtak
HARYANA
124001
India 
Phone  8607157000  
Fax    
Email  poonam.dhankher.jhajhria@gmail.com  
 
Details of Contact Person
Public Query  
Name  Shivam Soni 
Designation  Post Graduate Student 
Affiliation  College of Physiotherapy, Pt. B. D. Sharma, PGIMS Rohtak, Haryana 124001 
Address  Physiotherapy Department, E-Block, College of Physiotherapy, PGIMS ROHTAK, Haryana 124001

Rohtak
HARYANA
124001
India 
Phone  09253923740  
Fax    
Email  drshivamsoni2704@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  College of Physiotherapy, PGIMS Rohtak, Haryana 124001 
Address  Physiotherapy Department, E-Block, College of Physiotherapy, PGIMS ROHTAK, Haryana 124001 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Poonam Dhankher  Pt. B. D. Sharma, PGIMS Rohtak, Haryana 124001  Physiotherapy Department, E-Block, College of Physiotherapy, PGIMS ROHTAK, Haryana 124001
Rohtak
HARYANA 		 8607157000

poonam.dhankher.jhajhria@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Biomedical Research Ethics Committee, Pt. B. D. Sharma PGIMS/UHS, Rohtak  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthcare Professionals 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Healthcare professionals involved in sports medicine, physiotherapy, athletic training, and related fields.
2. Minimum one year of experience in sports-related healthcare 
 
ExclusionCriteria 
Details  1. Healthcare professionals without direct involvement in sports or athlete healthcare.
2. Undergraduate students still in training 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Knowledge level of FAT & RED-S in Healthcare Professionals  At Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="250"
Sample Size from India="250" 
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)   10/10/2025 
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="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 - NO
Brief Summary  

Background:
The Female Athlete Triad FAT first described in 1992 consists of disordered eating menstrual dysfunction and low bone mineral density. It was later broadened to Relative Energy Deficiency in Sport REDS recognized by the IOC in 2014 which results from low energy availability and affects multiple body systems including bone health immunity and cardiovascular function. Awareness of FAT and REDS among healthcare professionals is limited particularly among physiotherapists, general practitioners and gynaecologists. This lack of knowledge hinders early diagnosis and management increasing long term health risks for athletes.

Aims and Objectives:
Aim: To develop and validate a structured questionnaire for healthcare professionals to assess knowledge of Female Athlete Triad FAT and Relative Energy Deficiency in Sport REDS.

Objectives:

Develop a questionnaire based on literature and expert input
Establish content validity through expert review
Pilot test the questionnaire for feasibility clarity and initial reliability
Assess reliability and validity using statistical measures
Evaluate healthcare professionals knowledge of FAT and REDS

Methodology:
Design: Cross sectional mixed methods study
Population: Healthcare professionals in sports related fields with minimum one year of experience
Phases:
Phase 1 Expert review 10 experts for content validity
Phase 2 Pilot testing 30 professionals for clarity and reliability
Phase 3 Large scale validation 150 to 200 professionals for psychometric properties
Phase 4 Knowledge assessment 200 to 250 professionals
Tools: Structured self administered questionnaire consisting of multiple choice and Likert scale questions
Analysis: Cronbachs alpha ICC exploratory factor analysis Chi square t test and ANOVA using SPSS 26

Results: The expected outcomes include:
A valid and reliable questionnaire with good internal consistency Cronbachs alpha 08 or more
Clear evidence of construct validity and test retest reliability
Categorization of healthcare professionals knowledge levels into low, moderate and high

Conclusion:
This study will provide a validated questionnaire to assess healthcare professionals knowledge of FAT and REDS. The tool will help identify gaps in awareness and guide future educational programs enabling early recognition prevention and management of REDS among female athletes ultimately improving athlete health and performance.

 
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