| CTRI Number |
CTRI/2025/03/082134 [Registered on: 11/03/2025] Trial Registered Prospectively |
| Last Modified On: |
10/03/2025 |
| 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 Aerobic and Stretching Exercises Affect Hormones in Women with PCOS Type A |
|
Scientific Title of Study
|
Comparison of Aerobic exercises and Stretching exercises on Hormonal Parameters in Women with Polycystic Ovary Syndrome Phenotype A |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DivyaV |
| Designation |
MPT Student |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Sri Ramachandra Institute of Higher Education and Research,
Faculty of Physiotherapy 2nd Floor, No 1, Ramachandra Nagar, Porur, Chennai,TAMIL NADU,India
Sri Ramachandra Institute of Higher Education and Research,
Faculty of Physiotherapy 2nd Floor, No 1, Ramachandra Nagar, Porur, Chennai,TAMIL NADU,India
Chennai
TAMIL NADU
600116
India |
| Phone |
9514942200 |
| Fax |
|
| Email |
dhivyaphysio00@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ponmathi P |
| Designation |
Assistant Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Sri Ramachandra Institute of Higher Education and Research
Faculty of Physiotherapy 2nd Floor No 1 Ramachandra Nagar Porur
Chennai 600116
TAMIL NADU
India
Sri Ramachandra Institute of Higher Education and Research
Faculty of Physiotherapy 2nd Floor No 1 Ramachandra Nagar Porur
Chennai 600116
TAMIL NADU
India
Chennai
TAMIL NADU
600116
India |
| Phone |
9787211229 |
| Fax |
|
| Email |
ponmathi.p@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Ponmathi P |
| Designation |
Assistant Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Sri Ramachandra Institute of Higher Education and Research
Faculty of Physiotherapy 2nd Floor No 1 Ramachandra Nagar Porur
Chennai 600116
TAMIL NADU
India
Sri Ramachandra Institute of Higher Education and Research
Faculty of Physiotherapy 2nd Floor No 1 Ramachandra Nagar Porur
Chennai 600116
TAMIL NADU
India
Chennai
TAMIL NADU
600116
India |
| Phone |
9787211229 |
| Fax |
|
| Email |
ponmathi.p@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| Department of Obstetrics and Gynaecology
Sri Ramachandra Institute of Higher Education and Research
No 1 Sri Ramachandra nagar
Chennai 600116
Tamil Nadu |
|
|
Primary Sponsor
|
| Name |
DIVYA V Primary Investigator |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
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 |
| Ponmathi P |
Sri Ramachandra Hospital |
Room no1 First floor
Deparment of obstetrics and gynaecology
Sri Ramachandra hospital
Porur
chennai
Chennai
TAMIL NADU |
9787211229
ponmathi.p@sriramachandra.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Ramachandra Institute of Higher Education and Research Ethics Committee for Student projects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E889||Metabolic disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Aerobics |
Aerobic exercises will be given with 60-70 percent of target heart rate for a period of 12 weeks |
| Comparator Agent |
Stretching |
Various stretching of msucles with a hold time of 15 seconds for a period of 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Women aged 18-35 years diagnosed with PCOS
BMI within the overweight or obese category
Sedentary or Low to Moderate Physical Activity
|
|
| ExclusionCriteria |
| Details |
Pregnancy
Uncontrolled Medical Conditions
Drugs - Oral Contraceptives, ovulation induced drugs
Recent lower abdominal surgery
Recent fractures
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Luteinizing Hormone (LH)
Follicle- stimulating Hormone (FSH)
|
Baseline
4th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
21/03/2025 |
| 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="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
|
 Women with Polycystic Ovary
Syndrome volunteering in this program
will be screened
in Sri Ramachandra Institute
Of Higher Education
And Research from Physiotherapy,
Nursing, Dental, Engineering and Management departments will be taken for this
study. Based on the inclusion
criteria subjects will be randomly divided into 2 groups, Group A (Experimental group) and Group B (Control
group), Group A subjects will receive
Aerobic exercise using Motorized Treadmill. Group B subjects will receive
Stretching exercises. Both Group A and Group B have thrice a week session for 12 weeks. The
Aerobic exercises includes
walking on the treadmill for 20 minutes
(Moderate intensity - 60 - 70% of MHR) with 5 minutes of warm-up phase(Low
Intensity - 30% of MHR) and
cool down phase(Low intensity - 30% of MHR). The Stretching exercises includes
walking for 5 minutes around a room followed by 4 Upper- bodies and 4 Lower- bodies for 30
minutes with 2 repetitions and hold time of 20 seconds for each stretch and 5
minutes relaxation between each stretch. Subjects in both Group A and Group B
will be assessed through hormonal levels [ LH And FSH ] before and
after the interventions
|