| CTRI Number |
CTRI/2026/01/101849 [Registered on: 22/01/2026] Trial Registered Prospectively |
| Last Modified On: |
22/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective repeated-measures observational study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding how the menstrual cycle affects movement and injury risk in female athletes |
|
Scientific Title of Study
|
Menstrual cycle phase-dependent variations in neuromuscular control and biomechanical injury risk factor among female collegiate athletes: a repeated measure observational study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shramika |
| Designation |
Master of physiotherapy student |
| Affiliation |
Institute of Physiotherapy, Srinivas University |
| Address |
Institute of Physiotherapy,
Srinivas University, Department of Musculoskeletal and Sports Physiotherapy, ground floor,
City Campus, Pandeshwar, Mangaluru
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9901890286 |
| Fax |
|
| Email |
shramika2001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijayakumar Palaniswamy |
| Designation |
Professor |
| Affiliation |
Institute of Physiotherapy, Srinivas University |
| Address |
Institute of Physiotherapy,
Srinivas University, Department of Musculoskeletal and Sports Physiotherapy, ground floor,
City Campus, Pandeshwar, Mangaluru
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
918148745409 |
| Fax |
|
| Email |
vijayakumarpalaniswamy.ipt@srinivasuniversity.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Shramika |
| Designation |
Master of physiotherapy student |
| Affiliation |
Institute of Physiotherapy, Srinivas University |
| Address |
Institute of Physiotherapy,
Srinivas University, Department of Musculoskeletal and Sports Physiotherapy, ground floor,
City Campus, Pandeshwar, Mangaluru
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9901890286 |
| Fax |
|
| Email |
shramika2001@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Shramika |
| Address |
Institute Of Physiotherapy, Srinivas University, ground floor, city campus, Pandeshwar, Mangaluru, Dakshina Kannada, Karnataka |
| 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 |
| Shramika |
Institute of Physiotherapy, Srinivas University, MSD Pandeshwar, Mangaluru |
Institute Of Physiotherapy, Srinivas University, Department Of Musculoskeletal And Sports Physiotherapy ground floor, city campus, Pandeshwar, Mangaluru
Dakshina Kannada
KARNATAKA |
9901890286
shramika2001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL REVIEW BOARD AND ETHICAL COMMITTEE (IRBEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
menstrual cycle related neuromuscular and biomechanical variation |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
-Female athletes aged 18-25
-Actively training and participating in or more of the following sports: throw ball, runners, weight lifting, karate, etc.
-Eumenorrheic
-Engaged in structured training more than or equal to 3 times per week
-No musculoskeletal injuries requiring more than or equal to 7 days of rest in the past 6 months
|
|
| ExclusionCriteria |
| Details |
-Currently using hormonal contraceptives
-Diagnosed with PCOS or irregular menstrual cycles
-History of major lower limb surgery: ACL, PCL, MCL or LCL reconstruction/repair, meniscal repair
-Diagnosis or treatment for insomnia or other sleep disorder
-diagnosed endocrine disorder
-Taking medication that affect hormonal balance, neuromuscular control or cognitive function. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Y- balance test
Single-leg Hop
Drop Vertical Jump Test
Time-to-Stabilization Test
|
Follicular phase (baseline-day 2), ovulatory phase (day 14), luteal phase (day 21) within a single menstrual cycle
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Manual Menstrual Diary |
Written daily throughout one complete menstrual cycle |
Basal Body Temperature (BBT) Measurement
|
Daily throughout one menstrual cycle |
| Perceived Stress Scale (PSS) |
Follicular phase (day 2), ovulatory phase (Day 14),luteal phase ( day 21) within a menstrual cycle |
| Borg Rating of Perceived Exertion (RPE) |
Follicular phase, ovulatory phase, luteal phase |
| Low Energy Availability in Females Questionnaire (LEAF-Q) |
Baseline (day 2- follicular phase) of the menstrual cycle |
| Beighton Score |
Baseline ( day 2- follicular phase) of the menstrual cycle |
| Pittsburgh Sleep Quality Index (PSQI) |
Baseline ( day 2- follicular phase) of the menstrual cycle |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
02/02/2026 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 repeated- measures observational study evaluates menstrual cycle dependant variation in neuromuscular control among female collegiate athletes . Assessment will be done across 3 menstrual phases- follicular phase, ovulatory phase and luteal phase for primary outcomes. Secondary outcomes includes perceived stress, perceived exertion, sleep quality, general hyper mobility and risk of low energy availablity. Menstrual cycle charecteristics and ovulation confirmation will be done using manual dairy and daily basal body temperature measurement. All assessments are non-interventional and observational in nature. The study seeks to improve the understanding of menstrual cycle related neuromuscular variation that may influence injury risk in female athletes |