| 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
|
|
|
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
|
|
|
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. |