| CTRI Number |
CTRI/2025/09/094040 [Registered on: 01/09/2025] Trial Registered Prospectively |
| Last Modified On: |
29/08/2025 |
| 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 Physical Performance and Psychological Outcomes in aerobic and anaerobic Female Athletes |
|
Scientific Title of Study
|
Influence of Menstrual Phases on Physical Performance and Psychological Well-being in Female 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 |
SHRAVANI RAVULA |
| Designation |
MASTERS OF PHYSIOTHERAPY(SPORTS) |
| Affiliation |
LOVELY PROFESSIONAL UNIVERSITY |
| Address |
Room no 105 block 3 Department of Physiotherapy,School of Allied Medical Science,Lovely Professional University
Kapurthala PUNJAB 144411 India |
| Phone |
7330923914 |
| Fax |
|
| Email |
shravaniravula2707@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
SAKSHI SADHU |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
lovely professional university |
| Address |
Room no 105, Block 3 Department of Physiotherapy,School of Allied Medical Science,Lovely Professional University
Kapurthala PUNJAB 144411 India |
| Phone |
9596857767 |
| Fax |
|
| Email |
sakshi.22851@lpu.co.in |
|
Details of Contact Person Public Query
|
| Name |
SAKSHI SADHU |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
lovely professional university |
| Address |
Room no 105, Block 3 Department of Physiotherapy,School of Allied Medical Science,Lovely Professional University
Kapurthala PUNJAB 144411 India |
| Phone |
9596857767 |
| Fax |
|
| Email |
sakshi.22851@lpu.co.in |
|
|
Source of Monetary or Material Support
|
| Room no 105, Block 3 Department of Physiotherapy,School of Allied Medical Science,Lovely Professional University, Phagwara, Punjab, 144411 |
|
|
Primary Sponsor
|
| Name |
Shravani Ravula |
| Address |
Room no 105, Block 3 Department of Physiotherapy,School of Allied Medical Science,Lovely Professional University, Phagwara, Punjab, 144411 |
| Type of Sponsor |
Other [self-funded] |
|
|
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 SHRAVANI RAVULA |
lovely professional university |
Room no 105, Block 3 Department of Physiotherapy,School of Allied Medical Science,Lovely Professional University, Phagwara, Punjab, 144411 Kapurthala PUNJAB |
07330923914
shravaniravula2707@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE,LOVELY PROFESSIONAL UNIVERSITY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
HEALTHY REPRODUCTIVE FEMALE ATHLETES |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Actively competing female athletes from various sports disciplines
18-40 years of age group
Regular 28-day cycle with eumenorrheic patterns.
Non-pregnant women |
|
| ExclusionCriteria |
| Details |
Non menstruating females
Irregular menstrual cycles,
Pregnant women
hormonal contraceptive usage, or any medication that may influence the menstrual cycle.
Diagnosed metabolic disorders and underlying comorbidities
Diagnosed musculoskeletal disorder
Diagnosed mental disorders |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To analyse Cardiovascular endurance Strength Balance and psychological status of athletes
|
1 DAY
7 DAY
14 DAY
21 DAY
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| BMI |
BMI-1 DAY, 7 DAY, 14 DAY, 21 DAY
|
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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)
|
20/09/2025 |
| 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 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
|
Women aged 18–40 with regular 28/35 day menstrual cycles, who are not pregnant and have no metabolic or health conditions, will be invited to participate. They will receive a clear explanation of the study’s purpose, procedures, and their rights, including the ability to withdraw at any time, before providing informed consent. The study will begin with baseline assessments to understand participants’ initial physical and psychological states. Physical performance will be evaluated through endurance (6-minute walk test), strength (push-ups, squats, and crunches), and balance (Y-Balance Test and Single Leg Standing Test). Psychological well-being will be assessed using the Brunel Mood Scale (Brums), and BMI will be calculated based on height and weight. Participants will also be guided on how to track their menstrual cycles using a period-tracking app or a manual calendar to identify key phases: menstrual, follicular, ovulatory, and luteal. Data collection will occur every seven days, starting from the onset of the menstrual phase (Day 1) and continuing through the follicular (Day 7), ovulatory (Day 14), and luteal (Day 21) phases, concluding at the end of the luteal phase (Day 28). At each stage, participants will undergo a series of physical and psychological assessments, including mood evaluations using the Brums scale, physical performance tests, and BMI monitoring. |