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CTRI Number  CTRI/2025/01/079815 [Registered on: 31/01/2025] Trial Registered Prospectively
Last Modified On: 20/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Effects of menstrual cycle phases on fitness parameters among female Indian athlete. 
Scientific Title of Study   Impact of menstrual cycle phases on fitness determining physiological variables among sub-elite eumenorrheic 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  Hema Nandini T N 
Designation  MSc Exercise and Sports Sciences post graduate student. 
Affiliation  Manipal college of health professions 
Address  Department of Exercise and Sports Sciences, Manipal college of health professions, Manipal academy of health professions, Manipal.

Udupi
KARNATAKA
576104
India 
Phone  8073545835  
Fax    
Email  hemanandinitn21@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Tanugatri Majumder 
Designation  Assistant professor of department of Exercise and Sports Sciences  
Affiliation  Manipal college of health professions 
Address  Department of Exercise and Sports Sciences, Manipal college of health professions, Manipal academy of health professions, Manipal.

Udupi
KARNATAKA
576104
India 
Phone  8073545835  
Fax    
Email  tanugatri.majumder@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Tanugatri Majumder 
Designation  Assistant professor of department of Exercise and Sports Sciences  
Affiliation  Manipal college of health professions 
Address  Department of Exercise and Sports Sciences, Manipal college of health professions, Manipal academy of health professions, Manipal.

Udupi
KARNATAKA
576104
India 
Phone  8073545835  
Fax    
Email  tanugatri.majumder@manipal.edu  
 
Source of Monetary or Material Support  
Department of Exercise and Sports Sciences, Manipal College of Health Professions, MAHE, Manipal, Udupi, Karnataka, India -576104 
Self 
 
Primary Sponsor  
Name  Hema Nandini T N 
Address  Department of Exercise and Sports Sciences, Manipal college of health professions, Manipal academy of higher education, Manipal.  
Type of Sponsor  Other [Self] 
 
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 Hema Nandini T N  Center for Sports Science, Medicine and Research Lab, MCHP, Manipal.  Department of Exercise and Sports Science, MHCP, MAHE, Manipal, Karnataka-576104
Udupi
KARNATAKA 
8073545835

hemanandinitn21@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of Kasturba Medical College and Kasturba Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Female sub-elite athletes 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  Average menstrual cycle length 21 to 35 days (eumenorrheic).
Actively training for their respective sports for at least 6 months or
more.
Athlete is training for more than 5 hours per week.
Sub-elite athletes (One who train any sport for 5 to 6 hours in a week
and one who play district and state level competitions).
 
 
ExclusionCriteria 
Details  Uses hormonal contraceptives (currently or within the past 3
months).
Diagnosed with a menstrual disorder.
Diagnosed with an eating disorder.
Currently having musculoskeletal or neurological abnormalities or
chronic illness.
Having any injury that interferes with training or could risk
participation.
Pregnancy. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Physiological fitness variables  Duration is 3 months, where there will be 3 sessions per month. 
 
Secondary Outcome  
Outcome  TimePoints 
Not applicable  Not applicable 
 
Target Sample Size   Total Sample Size="18"
Sample Size from India="18" 
Final Enrollment numbers achieved (Total)= "18"
Final Enrollment numbers achieved (India)="18" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/02/2025 
Date of Study Completion (India) 01/02/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 30/04/2025 
Estimated Duration of Trial   Years="0"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
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
Modification(s)  
Primary objective: Impact of menstrual cycle (MC) phases on psychological measures pre and post a constant test plan among sub-elite eumenorrheic athletes. 

Justification for study: Fewer research has been conducted to understand the impact of MC phases on psychological measures among sub-elite eumenorrheic athletes. This study will help the coaches and athletes to tailor the training program at par with the MC phases and related symptoms. 

The study will be conducted after obtaining permission from the IRC and IEC approval, CTRI registration, and approval will be obtained. 

Subjects will be enrolled based on inclusion and exclusion criteria. The participants will be volunteering for the study. 

An informed consent form will be explained, and a signed consent form will be obtained for approval. 

On the first visit, demographic, sports-related, health-related, height, and body mass details will be taken. 

On the same visit, participants are explained about the procedure and familiarized with the protocol. 

The time (plus or minus 2 hours of the initial testing session), dietary intake, and nutritional supplements will be standardized or repeated during the testing period, and all will be informed to the participants on the same day. 

Before beginning the testing protocol, they will be required to complete the questionnaire (1), which is a pre-test questionnaire. After completing the questionnaire, participants will be asked to perform a series of tests. The tests will include assessments for Flexibility (Sit and Reach test), Muscular Endurance (Push-ups, Partial curl-ups), Anaerobic capacity (Wingate test), Muscle Power (Counter Movement Jump), and Agility (Illinois test). Following the tests, participants will be asked to complete a post-test questionnaire. This process will be repeated on nine separate visits over three months, and participants will be reminded of this protocol before each test.
 
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