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CTRI Number  CTRI/2025/07/090998 [Registered on: 16/07/2025] Trial Registered Prospectively
Last Modified On: 15/07/2025
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   The study explores the effects of two different exercise categories—jumping exercises (identified as plyometric training) and strength exercises (classified as resistance training)—on the heart health and fitness of overweight school children. 
Scientific Title of Study   Compare the effect of plyometric exercise training and resistance exercise training on cardiovascular fitness and body composition parameters in overweight school going adolescents – An experimental study 
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 Sandip Parekh 
Designation  Professor 
Affiliation  Parul Institute of Physiotherapy and Research, Parul University 
Address  Physiotherapy Department, Room No. 403 Parul Institute of Physiotherapy and Research, Parul University, Waghodia, Vadodara, Gujarat, India.

Vadodara
GUJARAT
391760
India 
Phone  9727081135  
Fax    
Email  sandip.parekh28008@paruluniversity.ac.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sonia Bhatia 
Designation  PhD Scholar 
Affiliation  Parul Institute of Physiotherapy and Research, Parul University 
Address  Physiotherapy Department, Room No. 403 Parul Institute of Physiotherapy and Research, Parul University, Waghodia, Vadodara, Gujarat, India.

Vadodara
GUJARAT
391760
India 
Phone  9638104748  
Fax    
Email  bhatia_sonia205@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sonia Bhatia 
Designation  PhD Scholar 
Affiliation  Parul Institute of Physiotherapy and Research, Parul University 
Address  Physiotherapy Department, Room No. 403 Parul Institute of Physiotherapy and Research, Parul University, Waghodia, Vadodara, Gujarat, India.

Vadodara
GUJARAT
391760
India 
Phone  9638104748  
Fax    
Email  bhatia_sonia205@yahoo.com  
 
Source of Monetary or Material Support  
B N College of Physiotherapy Anand Pincode-388001 Gujarat India. 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NO Sponsor] 
 
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 Sandip Parekh  Shree Krishna Hospital  K M Patel Institute of Physiotherapy, Physiotherapy Department, Room no.152, Gokal Nagar, Karamsad Anand Pincode-388325 Gujarat India
Anand
GUJARAT 
9727081135

sandip.parekh28008@paruluniversity.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee-2  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Overweight 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Plyometric training program   45 minutes per session, 3 times a week for 12 weeks 
Comparator Agent  Resisted training program   45 minutes per session, 3 times a week for 12 weeks 
 
Inclusion Criteria  
Age From  13.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Adolescents aged 13-18 years with overweight (BMI 23 to 24.9 kg/m2). Both genders will be included. 
 
ExclusionCriteria 
Details  Recent musculoskeletal injury, history of severe cardiovascular or neurological conditions, diagnosed Juvenile diabetes and known congenital heart disease.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Cardiovascular fitness will assessed by Queen’s Step Test   At Baseline, after 6 and 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Body Composition will be assessed by Bio-electrical Impedence Analyzer.

Quality of life by using Wellbeing of life questionnaire in overweight adolescents.
 
At Baseline, after 6 and 12 weeks 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
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)   01/09/2025 
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="3"
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  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 [bhatia_sonia205@yahoo.com].

  6. For how long will this data be available start date provided 01-01-2027 and end date provided 01-01-2032?
    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 study will compare the effect of plyometric exercise training and resistance exercise training on cardiovascular fitness and body composition parameters in overweight school going adolescents. The outcome will be assessed using the Queen’s Step Test to measure cardiovascular fitness, Bioelectrical Impedance Analyser for body composition and validated tools for assessing quality of life. At baseline, 6 weeks and 12 weeks the data will be collected. The study will be conducted at Anand District schools, Gujarat, India. 
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