| CTRI Number |
CTRI/2026/02/104431 [Registered on: 20/02/2026] Trial Registered Prospectively |
| Last Modified On: |
19/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Menstrual cycle phase-based training for female athletes - Randomized control trial |
|
Scientific Title of Study
|
EFFECT OF MENSTRUAL CYCLE PHASE-BASED TRAINING ON PHYSICAL FITNESS AND PSYCHOSOCIAL PARAMATERS AMONG FEMALE ATHELETES- A RANDOMIZED CONTROLLED TRIAL |
| Trial Acronym |
RCT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
BADDULA DIVYA KIRTHI |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
KAHER INSTITUTE OF PHYSIOTHERAPY |
| Address |
Room no 39, Advanced physiotherapy centre, Sagar ward, Department of sports, Nehru Nagar, Belgaum, Karnataka, India
Belgaum
KARNATAKA
590010
India |
| Phone |
9010518735 |
| Fax |
|
| Email |
badduladivyakeerthi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Basavaraj Motimath |
| Designation |
Professor and HOD at Department of Sports |
| Affiliation |
KAHER INSTITUTE OF PHYSIOTHERAPY |
| Address |
Room no 39, Advanced physiotherapy centre, Sagar ward, Department of sports, Nehru Nagar, Belgaum, Karnataka, India
Belgaum
KARNATAKA
590010
India |
| Phone |
9886100461 |
| Fax |
|
| Email |
basavarajmotimath@klekipt.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Basavaraj Motimath |
| Designation |
Professor and HOD at Department of Sports |
| Affiliation |
KAHER INSTITUTE OF PHYSIOTHERAPY |
| Address |
Room no 39, Advanced physiotherapy centre, Sagar ward, Department of sports, Nehru Nagar, Belgaum, Karnataka, India
Belgaum
KARNATAKA
590010
India |
| Phone |
9886100461 |
| Fax |
|
| Email |
basavarajmotimath@klekipt.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Baddula Divya Kirthi |
| Address |
KLE Academy of Higher Education and
Research Institute of Physiotherapy
J.N.Medical College Campus,
Nehru Nagar, Belgaum,
Karnataka, India. 590010 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 BASAVARAJ MOTIMATH |
KAHER INSTITUTE OF PHYSIOTHERAPY |
KLE Academy of Higher Education and
Research Institute of Physiotherapy
J.N.Medical College Campus,
Nehru Nagar, Belgaum,
Karnataka, India. 590010
Belgaum
KARNATAKA |
9886100461
badduladivyakeerthi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RESEARCH AND ETHICAL COMMITEE OF KAHER INSTITUTE OF PHYSIOTHERAPY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ATHLETES |
| Patients |
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
RAANDOMIZED CONTROL TRIAL |
This rct implements a structured protocol for female athletes over 12 weeks. The intervention is individualized according to the menstrual phases. Sessions are conducted 3 times per week lasting 60 min. Physical fitness components and psycho-social parameters are assessed pre and post intervention. |
| Comparator Agent |
RCT |
The comparator group follows their regular sport-specific training. No phase specific adjustments are made. Pre and post intervention assessments are conducted. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
Subjects willing to participate in the study.
Regular menstrual cycles (6 ± 3 cycles per year).
Engaged in regular competitive training for the chosen sport for at least 2 years.
Willing to track cycle and adhere to training and monitoring protocol.
|
|
| ExclusionCriteria |
| Details |
Irregular menstrual cycles or diagnosed menstrual disorders (e.g., PCOS, amenorrhea).
Current injury or musculoskeletal condition affecting training.
Pregnancy or lactation.
Use of hormonal contraceptives or therapy within 6 months.
Chronic medical conditions affecting exercise performance (e.g., cardiovascular, metabolic, or endocrine disorders).
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
agility performance
pyschological measures |
AGILITY PERFORMANCE
PRE TEST- 1 TIME
POST TEST - 1 TIMES
PYSCHOSOCIAL PERFORMANCE
PRE TEST-1 TIME
POST TIME- 1 TIME
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
16/03/2026 |
| 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="2"
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
|
this a randomized control trail checking whether a structured protocol developed for female athletes based on the menstrual cycle phases is reliable and if the results are inclining toward enhancing the athletic performance and psychosocial well-being of athlete. |