| CTRI Number |
CTRI/2025/07/092040 [Registered on: 30/07/2025] Trial Registered Prospectively |
| Last Modified On: |
30/07/2025 |
| 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
|
in our study we will be evaluating How Health Education Can Improve Knowledge, Attitude, and Physical Activity Habits in Children with Low Exercise Levels – and Its effect on their Parents and Teachers Too |
|
Scientific Title of Study
|
EFFECT OF HEALTH EDUCATIONAL STRATERGIES ON EXERCISE DEFICIT DISORDER RELATED KNOWLEDGE, ATTITUDE AND BEHAVIOUR OF PHYSICAL ACTIVITY AMONG SCHOOL GOING CHILDREN THEIR PARENTS AND TEACHERS 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 Prajakta Taksale |
| Designation |
postgraduate student |
| Affiliation |
MGM School of physiotherapy |
| Address |
Department of Cardiovascular and Respiratory Physiotherapy c building n6 mgm school of physiotherapy,chh.sambhajinagar maharashtra India 431001
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
09767409303 |
| Fax |
|
| Email |
prajaktataksale080@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Junneshwar bidve |
| Designation |
professor |
| Affiliation |
MGM School of physiotherapy |
| Address |
Department of Cardiovascular and Respiratory Physiotherapy c building n6 mgm school of physiotherapy,chh.sambhajinagar maharashtra India 431001
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
8237197885 |
| Fax |
|
| Email |
prajaktataksale080@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Junneshwar bidve |
| Designation |
professor |
| Affiliation |
MGM School of physiotherapy |
| Address |
Department of Cardiovascular and Respiratory Physiotherapy c building n6 mgm school of physiotherapy,chh.sambhajinagar maharashtra India 431001
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
8237197885 |
| Fax |
|
| Email |
junneshwarb@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGM School of physiotherapy n6 cidco chhtrapati sambhajinagar |
|
|
Primary Sponsor
|
| Name |
Dr Prajakta Taksale |
| Address |
Department of cardiovascular and respiratory physiotherapy c building mgm school of physiotherapy chh.sambhajinagar maharashtra india 431001 |
| 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 |
| DrPrajakta taksale |
Dr.Prajakta Taksale |
Department of Cardiovascular and Respiratory Physiotherapy c building n6 mgm school of physiotherapy,chh.sambhajinagar maharashtra India 431001
Aurangabad
MAHARASHTRA |
09767409303
prajaktataksale080@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for Research on human subjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z723||Lack of physical exercise, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Participants in Group A will receive a comprehensive intervention combining education, home exercises, and school-based activities. |
Parents, teachers, and children will be educated about Exercise Deficit Disorder (EDD), its causes, effects, and preventive measures through interactive sessions.
A structured home exercise program, including aerobic, strength, and flexibility exercise , fun activities will be provided and prescribed for 30 minutes a day. Additionally, fun physical activities such as relay races, obstacle courses, and group games will be conducted during school hours.
Weekly follow-ups will be carried out to monitor adherence, and feedback sessions will ensure continuous support and motivation for parents and teachers
|
| Comparator Agent |
Participants in Group B will receive an intervention focused on education and motivation. |
Participants in Group B will receive an intervention focused on education and motivation. Lectures and seminars will be conducted to provide knowledge about Exercise Deficit Disorder, its impact, and the benefits of physical activity for overall health.
Group counseling sessions will emphasize the importance of regular exercise and simple ways to incorporate physical activity into daily routines.
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
For School Children
Aged between 6-12 years
Enrolled in the selected school
Willing to provide assent and whose parents provide written informed consent
For Parents
Parents or legal guardians of participating children
Willing to participate
Provide written informed consent
For School Staff
Willing to participate
|
|
| ExclusionCriteria |
| Details |
For School Children
Decline to provide assent or whose parents decline to provide consent
For Parents
Unavailable during the intervention period due to professional or personal commitments
Not willing to participate in physical activity programs or awareness sessions
For School Staff
Not willing to attend awareness sessions or participate in interventions
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Vertical Jump Test
Shuttle Run Test |
pre and post intervention 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Knowledge Attitude and Behaviour towards Physical Activity Questionnaire.
Children Physical Activity Questionnaire.
|
pre and post intervention 6 week |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
20/08/2025 |
| 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="0"
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
|
This randomized controlled trial aims to evaluate the impact of structured health education strategies on improving knowledge, attitudes, and physical activity-related behaviours linked to Exercise Deficit Disorder (EDD) in school-going children aged 6 to 12 years, their parents, and teachers.The written and oral consent of all patients will be taken ,and procedure will be explained.Demographic data will be noted. Baseline data which will include shuttle run test ,vertical jump test,children physical activity questionnaire and knowledge ,attitude and behaviour towards physical activity questionnaire will be assessed.The participants will be randomly divided into two study groups intervention group,control group.the participants will receive intervention as per the group allocation for 6 weeks.The intervention group will receive a comprehensive
intervention combining education, home exercises, and school-based activities.Parents, teachers, and children will be educated about
Exercise Deficit Disorder (EDD), its causes, effects, and preventive measures
through interactive sessions.A structured home
exercise program, including aerobic, strength, and flexibility exercise , fun
activities will be provided and
prescribed for 30 minutes a day. Additionally, fun physical activities such as
relay races, obstacle courses, and group games will be conducted during school
hours.Weekly follow-ups will be carried out to monitor adherence,
and feedback sessions will ensure continuous support and motivation for parents
and teacher. Participants in control group will
receive an intervention focused on education and motivation. Lectures and
seminars will be conducted to provide knowledge about Exercise Deficit
Disorder, its impact, and the benefits of physical activity for overall health.Group counseling sessions will emphasize the
importance of regular exercise and simple ways to incorporate physical activity
into daily routines.outcome measures will be assessed pre and post intervention period.statistical analysis of collected data will be done.conclusion will be established based on the obtained results of the study.
|