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CTRI Number  CTRI/2025/03/082431 [Registered on: 17/03/2025] Trial Registered Prospectively
Last Modified On: 14/03/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive
Process of Care Changes
Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Zumba for Heart Health: A Study on Women with PCOS 
Scientific Title of Study   Impact of Zumba Exercise Training on Arterial Stiffness, Pulse Wave Velocity and Serum Homocysteine levels among female adults with Polycystic Ovarian Syndrome.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
ICMR STS-2024-05472  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Manisha R 
Designation  3rd year MBBS student  
Affiliation  All India Institute of Medical Sciences, Mangalagiri. 
Address  Room number: 102, 1st Floor, Department of Physiology, Medical College Building, All India Institute of Medical Sciences, Mangalagiri, Guntur district, Andhra Pradesh, India.

Guntur
ANDHRA PRADESH
522503
India 
Phone  8072197606  
Fax    
Email  manisha656manisha@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sharmila V 
Designation  Professor and HOD (Co Guide), Department of Obstetrics and Gynecology  
Affiliation  All India Institute of Medical Sciences, Mangalagiri 
Address  Room number 305, Department of Obstetrics and Gynecology, Outpatient Department, AIIMS mangalagiri.

Guntur
ANDHRA PRADESH
522502
India 
Phone  9843776367  
Fax    
Email  sharu_jipmer@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Satish P Dipankar  
Designation  Professor and HOD(Guide)Department of Physiology  
Affiliation  All India Institute of Medical Sciences, Mangalagiri. 
Address  Room number 102, 1st floor, Department of Physiology, Medical College Building, AIIMS Mangalagiri.

Guntur
ANDHRA PRADESH
522502
India 
Phone  9923030375  
Fax    
Email  drsdipankar@aiimsmangalagiri.edu.in  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Mangalagiri, Guntur District, Andhra Pradesh, India. Pin Code: 522503. 
 
Primary Sponsor  
Name  Manisha R 
Address  Room number : 102, First Floor, Department of Physiology, Medical College Building, All India Institute of Medical sciences, Mangalagiri, Guntur district, Andhra Pradesh, India. PIN code : 522503. 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Satish P Dipankar   AIIMS Mangalagiri  Room number 133, Autonomic Function Test Lab, 1st floor, Outpatient department , AIIMS Mangalagiri, Guntur district, Andhra Pradesh, India. PIN code: 522503.
Guntur
ANDHRA PRADESH 		 9923030375

drsdipankar@aiimsmangalagiri.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Mangalagiri Institute Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E282||Polycystic ovarian syndrome,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  No Zumba exercise   Only routine medical treatment without Zumba exercise. 
Intervention  Zumba Exercise  For 3 months : Every Morning - 24 min of Zumba dance (5 min warm up + 6 min practice + 6 min rest - repeated 4 times finally 5 mins cool down). The total duration of one session: 58 mins [5 mins warm up + 24 mins Zumba + 24 mins rest + 5 mins cool down]) Routine medical treatment will be continued.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Female 
Details  1.Modified Rotterdam criteria, in which PCOS may be diagnosed if any two of the following are present: (1) clinical or biochemical hyperandrogenism, (2) evidence of oligo-anovulation, (3) polycystic appearing-ovarian morphology on ultrasound, with exclusion of other relevant disorders.
2.Nonpregnant woman
3.Recently diagnosed PCOS participants
4.Willingness to participate in the study and provide informed consent
 
 
ExclusionCriteria 
Details  1.Participants who are on oral contraceptive pills (OCP)
2.History of chronic systemic illness (DM, HT, TB, etc)
3.Subjects currently on medication against systemic diseases
4.Smokers and Alcoholic
5.History of cardiovascular or cerebrovascular disease.
6.Pregnancy or planning pregnancy during the study period.
7.Use of medications that could affect vascular function (e.g., anticoagulants).
8. Women who did not consent
 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Decrease in arterial stiffness
(measured by pulse wave velocity and augmentation index).
2. Decrease in serum homocysteine levels.
 		 3 months
 
 
Secondary Outcome  
Outcome  TimePoints 
1. Decrease in Blood Pressure
2. Change in Body Composition( measured by BMI, waist circumference, Waist to hip ratio)
3. Change in Quality of Life (assessed by FertiQOL and Pittsburgh Sleep Quality Index questionnaire)
4. Better Heart Rate Variability  		 3 months  
 
Target Sample Size   Total Sample Size="54"
Sample Size from India="54" 
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)   25/03/2025 
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="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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [manisha656manisha@gmail.com].

  6. For how long will this data be available start date provided 01-10-2025 and end date provided 21-10-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

This randomized controlled trial with aims to evaluate the impact of Zumba training on arterial stiffness, pulse wave velocity (PWV), and other health parameters in women aged 18–25 with PCOS by measuring parameters before and after 3 months of Zumba exercise. A total of 54 participants will be randomized into a Zumba intervention group and a control group receiving standard care. The intervention involves 168 minutes of Zumba weekly (24 minutes daily), online sessions over three months. Key outcomes include anthropometric measurements (e.g., BMI, waist-to-hip ratio), physiological parameters (e.g., heart rate, blood pressure, Pulse wave velocity, Augmentation Index, Resting heart rate variability ), psychophysiological factors (e.g., stress levels, sleep quality), and serum homocysteine levels.

This study has significant implications. Clinically, Zumba could serve as a non-pharmacological intervention to improve vascular health and reduce CVD risk in women with PCOS. From a public health perspective, integrating enjoyable exercise programs like Zumba into broader health initiatives could enhance adherence, reduce PCOS-related complications, and promote cardiovascular health across populations.

 
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