| CTRI Number |
CTRI/2025/11/096965 [Registered on: 06/11/2025] Trial Registered Prospectively |
| Last Modified On: |
04/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Effect Of Aerobic Versus Resistance Exercises On Biomarker Of Hyperandrogenism In PCOS: A Randomized Controlled Trial |
|
Scientific Title of Study
|
Effect Of Aerobic Versus Resistance Exercises On Clinical Markers Of Hyperandrogenism In PCOS: A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr SUMEDHA MANE |
| Designation |
Assistant Professor Department Of Community Based Rehabilitation |
| Affiliation |
KAHER Institute Of Physiotherapy |
| Address |
Advanced Physiotherapy Center OPD Number 39 Sagar Floor Dr Prabhakar Kore Hospital And MRC Nehru Nagar Belagavi 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9008246328 |
| Fax |
|
| Email |
sumedhamane@klekipt.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SUMEDHA MANE |
| Designation |
Assistant Professor Department Of Community Based Rehabilitation |
| Affiliation |
KAHER Institute Of Physiotherapy |
| Address |
Advanced Physiotherapy Center OPD Number 39 Sagar Floor Dr Prabhakar Kore Hospital And MRC Nehru Nagar Belagavi 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9008246328 |
| Fax |
|
| Email |
sumedhamane@klekipt.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
SAKSHI R MALAKASHETTI |
| Designation |
Student |
| Affiliation |
KAHER Institute Of Physiotherapy |
| Address |
Advanced Physiotherapy Center OPD Number 39 Sagar Floor Dr Prabhakar Kore Hospital And MRC Nehru Nagar Belagavi 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
8296032484 |
| Fax |
|
| Email |
malakashettisakshiramesh@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Dr Prabhakar Kore Hospital And Research Center Nehru Nagar Belgaum |
|
|
Primary Sponsor
|
| Name |
KAHER Institute Of Physiotherapy |
| Address |
KAHER Institute Of Physiotherapy JNMC Campus Nehru Nagar Belagavi 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 Sumedha Mane |
KAHER Institute Of Physiotherapy |
Advanced Physiotherapy Center OPD Number 39 Sagar Floor Dr Prabhakar Kore Hospital And MRC Nehru Nagar Belagavi 590010
Belgaum
KARNATAKA |
9008246328
sumedhamane@klekipt.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC KLE ACADEMY OF HIGHER EDUCATIOM ANND RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E345||Androgen insensitivity syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Aerobic exercises |
progressive moderate intensity aerobic program targeting 150min per week
weekly plan(6week)
week 1 brisk walking or treadmill or cycling
3 sessions per week 25min per session equals to 75 min per week
week2 3 sessions per week 30 min per session equals to 90 min per week
week 3 to 6 4 sessions per week 35 to 40 min per session equals to 140 to 160 min per week |
| Comparator Agent |
Resistance exercises |
weekly plan(6 weeks)
week1 2 sessions per week 40 min per session Exercises like body weights or bands or machines(squats leg press chest press seated row shoulder press lateral pull down hamstring exercises core plank) 2 sets x 12 to 15 reps per exercises
week 2 to 3 2 to 3 sessions per week 45 min per session 2 to 3 sets x 10 to 12 reps
week 4 to 6 3 sessions per week 45 to 50 min per session 3 sets x 8 to 12 reps |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Female aged 18 years to 40 years
Women already diagnosed with PCOS by either Rotterdam or NIH Criteria
Clinical Evidence Of Hyperandrogenism Hirsutism(mFG score greater than or equal to 8) and or Active Acne(Clinically Countable Lesions) |
|
| ExclusionCriteria |
| Details |
Current use (within past 3 months) of systemic anti-androgen medications
Pregnant planning pregnancy during study or breastfeeding
Known endocrine disorders other than PCOS that affect androgens (eg Cushings syndrome androgen secreting tumor)
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Modified Ferriman Gallwey score (mFG)
Acne lesion count assessment
|
Baseline (0 week)
Mid point (3 week)
End point (6 week) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
16/11/2025 |
| 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 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
|
Polycystic Ovary Syndrome (PCOS) is a prevalent endocrine disorder among women of reproductive age characterized by hyperandrogenism ovulatory dysfunction and polycystic ovaries. Symptoms such as hirsutism acne menstrual irregularities and psychological distress significantly impact quality of life. Insulin resistance and hormonal imbalances play a central role in its pathophysiology. Lifestyle modification particularly exercise is considered a first line treatment. While both aerobic exercise and high intensity resistance training (HIRT) improve metabolic and reproductive outcomes their specific effects on the psychological well being of women with PCOS remain less understood. This study aims to explore and compare the impact of these two exercise modalities on the clinical markers of Hyperandrogenism in PCOS.
Objective To compare the change in Modified Ferriman Gallwey (mFG) score from baseline to 6 weeks between the Aerobic (Group A) and Resistance (Group B) groups. To compare change in acne lesion count from baseline to 6 weeks.
Methodology A Randomized Controlled Trial will be conducted to evaluate the effects of exercise modalities on women with PCOS. A total of 70 women aged 18 to 40 years diagnosed with PCOS based on Rotterdam or NIH criteria and showing clinical signs of hyperandrogenism (hirsutism with mFG score greater than equal to 8 and or active acne) were randomly assigned using the SNOSE method. The study spanned 6 weeks. Exclusion criteria included recent use of anti androgen medications pregnancy or lactation and other endocrine disorders affecting androgen levels. This study seeks to compare the effects of a 6 week aerobic exercise program versus resistance exercise program. |