| CTRI Number |
CTRI/2026/02/103404 [Registered on: 09/02/2026] Trial Registered Prospectively |
| Last Modified On: |
06/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To find the Effect of Structured exercise program on physical fitness of school going children of various rural and urban schools in and around anand, Gujarat |
|
Scientific Title of Study
|
Effect of Structured exercise program to improve physical health among school going children in and around anand, Gujarat |
| 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 Hardik Suthar PT |
| Designation |
Assistant Professor |
| Affiliation |
K M Patel Institute of Physiotherapy |
| Address |
Shree Krishna Hospital, K M Patel Institute of Physiotherapy, OPD No 152, Karamsad, Anand, Gujarat, India
Anand
GUJARAT
388325
India |
| Phone |
09408209030 |
| Fax |
|
| Email |
hardiksuthar1995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hardik Suthar PT |
| Designation |
Assistant Professor |
| Affiliation |
K M Patel Institute of Physiotherapy |
| Address |
Shree Krishna Hospital, K M Patel Institute of Physiotherapy, OPD No 152, Karamsad, Anand, Gujarat, India
Anand
GUJARAT
388325
India |
| Phone |
09408209030 |
| Fax |
|
| Email |
hardiksuthar1995@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr R Harihara Prakash PT |
| Designation |
Professor |
| Affiliation |
K M Patel Institute of Physiotherapy |
| Address |
Shree Krishna Hospital, K M Patel Institute of Physiotherapy, OPD No 152, Karamsad, Anand, Gujarat, India
Anand
GUJARAT
388325
India |
| Phone |
8238238685 |
| Fax |
|
| Email |
hariharap@charutarhealth.org |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
K M Patel Institute of Physiotherapy |
| Address |
Bhaikaka University, Shree Krishna Hospital, Gokal Nagar, Karamsad, Gujarat. 388325 |
| Type of Sponsor |
Other [Teaching and Research Institution] |
|
|
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 Hardik Suthar PT |
K M Patel Institute of Physiotherapy |
Bhaikaka University, Shree Krishna Hospital, K M Patel Institute of Physiotherapy, OPD No 152, Karamsad, Anand, Gujarat, India
Anand
GUJARAT |
09408209030
hardiksuthar1995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituional Ethics Committee-2, H M Patel Academic Center, Bhaikaka University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Reduced Physical fitness levels among school going children |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No Comparison |
No Comparison |
| Intervention |
Physical Therapy Intervention |
Structured Exercise program including aerobic exericses, strenghtening exercises, flexibility training, 45 minutes duration, 3 session per week for 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
11.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
Who are apparently healthy, with a sedentary or low to moderate active lifestyle and physically capable of participating in moderate to vigorous exercise, availability to attend the full intervention program, With consent from parent and assent of children. |
|
| ExclusionCriteria |
| Details |
With a chronic medical condition such as GBS, Asthma, cardiopulmonary disease, developmental disorders, or acute recent injury, individuals who are already involved in an athletic training program. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Body Composition Analysis, Cardiopulmonary endurance, Muscle Strength & Power, Flexibility, Agility and coordination |
Baseline & Post to 12 Weeks intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in BMI, Agility & coordination |
Baseline, 12 Weeks |
|
|
Target Sample Size
|
Total Sample Size="296"
Sample Size from India="296"
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)
|
28/02/2026 |
| 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="9"
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
|
It is a prospective single-group pre-post trial for assessing the effect of physical fitness in school-going children in and around Anand. Once post approval from CTRI, we will be recruiting the children and categorising their physical fitness and a standardised protocol of exercise targeting various components of physical fitness will be given. It is an initiative for the school health program |