| CTRI Number |
CTRI/2025/07/090082 [Registered on: 02/07/2025] Trial Registered Prospectively |
| Last Modified On: |
28/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
How various forms of exercise can help young women feel better before their periods. |
|
Scientific Title of Study
|
Impact of Aerobic exercises and Pilates for Premenstrual syndrome and Quality of life: Insights into Cortisol Dynamics among young Women |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Karthika SR |
| Designation |
PhD Scholar |
| Affiliation |
Saveetha Institute of Medical and Technical Sciences |
| Address |
Room 5A2, 5th floor health science block, Saveetha College of Physiotherapy, Saveetha Institute of Medical and Technical Sciences, Saveetha Nagar, Thandalam, Chennai.
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
9677001902 |
| Fax |
|
| Email |
karthikabr2111@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
kamalakannan M |
| Designation |
Professor |
| Affiliation |
Saveetha Institute of Medical and Technical Sciences |
| Address |
Room 5B2, 5th floor health science block, Saveetha College of Physiotherapy, Saveetha Institute of Medical and Technical Sciences, Saveetha Nagar, Thandalam, Chennai.
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
9600004487 |
| Fax |
|
| Email |
kamal1712@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
kamalakannan M |
| Designation |
Professor |
| Affiliation |
Saveetha Institute of Medical and Technical Sciences |
| Address |
Room 5B2, 5th floor health science block, Saveetha College of Physiotherapy, Saveetha Institute of Medical and Technical Sciences, Saveetha Nagar, Thandalam, Chennai.
Kancheepuram
TAMIL NADU
602105
India |
| Phone |
9600004487 |
| Fax |
|
| Email |
kamal1712@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha College of Physiotherapy, Saveetha Institute of Medical and Technical Sciences |
|
|
Primary Sponsor
|
| Name |
Saveetha College of Physiotherapy, Saveetha Institute of Medical and Technical Sciences |
| Address |
Room 5A2, 5th floor health science block, Saveetha College of Physiotherapy, Saveetha Institute of Medical and Technical Sciences, Saveetha Nagar, Thandalam, Chennai. |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Karthika SR |
Saveetha College of Physiotherapy |
Room No. 4A2, 4th floor health science block, Saveetha College of Physiotherapy, Saveetha Institute of Medical and Technical Sciences, Saveetha Nagar, Thandalam, Chennai.
Kancheepuram
TAMIL NADU |
9677001902
karthikabr2111@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Medical College and Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N943||Premenstrual tension syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
aerobics |
5 days a week for 12 weeks |
| Comparator Agent |
conventional therapy |
5 days a week for 12 weeks |
| Intervention |
pilates |
5 days a week for 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Female |
| Details |
Age group 18 to 22 years
Regular menstrual cycle
Symptoms of pre menstrual syndrome for 3 months
Participants with BMI of 18.5 to 29.9
Nullipara |
|
| ExclusionCriteria |
| Details |
Pelvic inflammatory diseases, gynecological diseases, Cyst, fibroids and other growths in uterus ovaries and fallopian tube.
History of any specific diseases and compulsory use of specific drugs
Participants with neurological disorders
Participants with musculoskeletal disorders |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Premenstrual syndrome questionnaire
Quality of health questionnaire
Cortisol |
baseline and post intervention |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="284"
Sample Size from India="284"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
25/07/2025 |
| 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 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 study will be conducted to assess the effectiveness of different exercise interventions in managing Premenstrual Syndrome (PMS) symptoms, reducing stress hormone (cortisol) levels, and improving quality of life in women of reproductive age of 18 to 25 years. Participants will be screened using a standardized Premenstrual Syndrome Questionnaire to confirm the presence and severity of PMS symptoms. Eligible participants will then be randomly assigned to different exercise protocols and will participate in a structured exercise program for three months, with sessions held three times per week.
The types of exercises will include aerobic workouts, Pilates-based movements, and general stretching routines. Each form of exercise will be selected for its potential physiological and psychological benefits, such as hormone regulation, muscular relaxation, and mood enhancement.
To evaluate the outcomes, three validated tools will be used.
* cortisol levels – to measure the biological stress response, * Premenstrual Syndrome Questionnaire – to assess changes in PMS symptoms, * Quality of Life Questionnaire – to determine the overall impact on participants’ physical and mental well-being.
Assessments will be conducted at baseline and after the three-month intervention. The results aims to identify which type of exercise will be most effective in alleviating PMS symptoms, regulating cortisol, and enhancing the quality of life. This study will highlight the potential of non-pharmacological, exercise-based approaches in the holistic management of PMS. |