| 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
|
|
|
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
|
|
|
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
- 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).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [bhatia_sonia205@yahoo.com].
- 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.
- 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. |