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CTRI Number  CTRI/2024/03/064136 [Registered on: 14/03/2024] Trial Registered Prospectively
Last Modified On: 26/02/2024
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   Impact of School-based Exercise Programs on Physical Health and Lifestyle in Secondary School Students - A Randomized Controlled Trial 
Scientific Title of Study   Effects of school-based exercise program on physical parameters and lifestyle amongst secondary school children: A 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  Pranav Pravin Bothare  
Designation  BPTh 
Affiliation  DR. APJ Abdul Kalam College of Physiotherapy 
Address  Dr A P J Abdul Kalam college of Physiotherapy, Pravara Institute of Medical Sciences, Loni ,413736

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  09769584314  
Fax    
Email  pranavbothare@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Tejas Borkar  
Designation  Associate Professor  
Affiliation  DR. APJ Abdul Kalam College of Physiotherapy 
Address  Dr A P J Abdul Kalam college of Physiotherapy, Pravara Institute of Medical Sciences, Loni ,413736

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  9371271752  
Fax    
Email  tejasborkar57@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Tejas Borkar  
Designation  Associate Professor  
Affiliation  DR. APJ Abdul Kalam College of Physiotherapy 
Address  Dr A P J Abdul Kalam college of Physiotherapy, Pravara Institue of Medical Sciences, Loni ,413736

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  9371271752  
Fax    
Email  tejasborkar57@gmail.com  
 
Source of Monetary or Material Support  
Dr. A.P.J Abdul Kalam College of Physiotherapy, PIMS DU.  
 
Primary Sponsor  
Name  Dr. A.P.J Abdul Kalam College of Physiotherapy, PIMS DU. 
Address  Pravara Institute of Medical Sciences, Dr.A.P.J Abdul Kalam college of Physiotherapy, Loni ,413736 
Type of Sponsor  Private medical college 
 
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 Pranav Bothare  503, Pediatric Physiotherapy Department, Dr A P J AK College of Physiotherapy  Loni, Ahmadnagar
Ahmadnagar
MAHARASHTRA 
09769584314

pranavbothare@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Dr A P J AK College of Physiotherapy  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Secondary School going children  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  CONTROL GROUP   They will be given the conventional Exercise Protocol being followed during PE classes in the school priorly. Following exercises will be performed by them over period of 6 weeks- Spot marching Jumping Jacks Planks Abdominal crunches Lunges  
Intervention  School Based Exercise Program   WEEK 1 to 3 PHASE 1 (WARM UP PHASE) Static Stretching – forward bending, sideway bending, trapezius stretch, wrist stretch, Hamstrings stretch and Quadriceps stretch. PHASE 2 (WORKOUT PHASE) Rope jumping, Hopping, Running, Bodyweight squats, push ups, Mountain climbers. PHASE 3 (COOL DOWN PHASE) Jacobsen’s Relaxation/Shavasana. WEEK 4 to 6 PHASE 1 (Warm Up Phase) Static Marching, Jumping Jacks, Sack Race. PHASE 2 (Exercise Phase) Obstacle course, Animal Walks, Running with the ball, Ball throwing, Tug of war. PHASE 3 (Cool Down Phase) Imagination meditation with nature sounds  
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  15.00 Year(s)
Gender  Both 
Details  Secondary School children between 5th to 10th standards (around 10-15 years of age).
Written and signed consent forms from parents/guardians/teachers.
 
 
ExclusionCriteria 
Details  Secondary School children between 5th to 10th standards (around 10-15 years of age).
Written and signed consent forms from parents/guardians/teachers.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Aerobic Capacity, Muscular Endurance, Body Mass Index, Rosenberg Sedentary Lifestyle Questionnaire.   week 0 and week 6 
 
Secondary Outcome  
Outcome  TimePoints 
Age, Gender   week 0 and week 6 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   25/03/2024 
Date of Study Completion (India) 12/03/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

INTRODUCTION

Childhood is crucial for developing physical, cognitive, and social skills. However,

sedentary behaviour and lack of physical activity (PA) amongst children is an important issue that needs to be addressed [1]. Children’s lifestyles are becoming increasingly sedentary, with a growing trend of spending long hours sitting in front of screens and engaging in minimal physical activity [1].

As defined by the World Health Organization (2020), sedentary behaviour is defined as any waking behaviour characterized by an energy expenditure of 1.5 METS (metabolic equivalents; multiples of basal metabolic rates) or lower while sitting, reclining, or lying, while physical activity is defined as any bodily movement produced by skeletal muscles that requires energy expenditure [21].

One of the significant causes of sedentary behaviour and lack of physical activity among

children are the increasing reliance on technology and screens [13]. With the proliferation of smartphones, tablets, and other electronic devices, children spend more time sitting in front of screens than engaging in physical activities [13]. This trend is compounded by the fact that many schools need more facilities or programs for physical education, making it difficult for children to get the exercise they need [1,2].

Physical inactivity has been linked to noncommunicable disease and economic burden globally, and poses significant challenges in rapidly growing countries including India, which is currently home to the second largest population in the world [5].  Physical inactivity is a modifiable risk factor for cardiovascular disease and a widening variety of other chronic diseases, including diabetes mellitus, cancer (colon and breast), obesity, hypertension, bone and joint diseases (osteoporosis and osteoarthritis), and depression [5].

A growing number of studies report that regular physical activity (PA) during childhood is associated with physical, mental, emotional and social health benefits [8]. Physical activity plays a protective role against excessive body fat mass and positively correlates with health indicators such as health status, self-image, quality of life and family and peer relationship, as well as healthy child development [5].

Physical fitness refers to a physiologic state of well-being that allows one to meet the demands of daily living or that provides the basis for sport performance, or both [1]. Health-related physical fitness involves the components of physical fitness related to health status, including cardiovascular fitness, musculoskeletal fitness, body composition and metabolism [1,2]. In large epidemiologic investigations, physical activity and physical fitness are often used interchangeably, with fitness commonly being treated as a more accurate measure of physical activity than self-report [8].

Considering that children spend many hours at school, the classroom is the ideal setting to promote children’s PA, since it gives access to children regardless of age, ethnicity, gender and socio-economic status [5]. Previous systematic reviews showed that classroom-based PA had a positive impact on physical activity level, classroom behaviour, cognitive functions and academic achievement [1]. Several mechanisms might explain the effects of PA on cognitive functions and academic performance [5]. First, acute PA causes the release of neurotransmitters, which increase physiological arousal and attention levels, consequently enhancing the cognitive performance [5]. Secondly, continuous aerobic physical activity is thought to enhance the angiogenesis and neurogenesis in areas of the brain involved in memory and learning functions. The improvements regarding executive functions and attention may, in turn, improve the academic performance of preadolescent children [5,8].

In order to avoid the risk of metabolic and cardiovascular dis-eases, the World Health Organization (WHO) recommends that children and adolescents aged 5 to 17 years should accumulate at least 60 min per day of MVPA [2]. Despite this, global estimates indicate that low percentages of children and adolescents comply with WHO recommendations [2].

NEED FOR THE STUDY

 

It is important to perform physical activities or exercises to improve likelihood of healthy lifestyle. Participating in Physical Activity has shown to have mental, emotional, physical benefits as well as improve academic performance. School students in India, students in secondary school i.e. between 5th to 10th standards, face challenges like academic pressures, mental health concerns, adapting to new technology-driven learning methods, due to which they are stuck to their chairs or seats for prolonged durations leading to risks of back pain, eye strain from excessive screen time and disrupted sleep due to irregular sleeping and eating schedules. Poor nutrition and lack of exercises can contribute to health challenges. Additionally, the constant use of screen can lead to posture and eyesight problems. Insufficient physical activity can lead to weight-related issues and reduced cardiovascular health, which in turn can lead to chronic conditions in longer run. Physical Education (PE) in school plays vital role in developing a child, thus promoting overall health and well-being. However, schools these days want their children to be in front in all academic aspects, except sports. The time given to the PE classes is limited and there are many instances where these classes are replaced by other subjects. These situations lead to lack of importance given to physical health and aversion of students to liking any sports. Also, PE teaches essential skills like teamwork, discipline, and goal setting. However, lack of PE can lead to health risks, decreased focus, and a missed opportunity to develop crucial social and motor skills.

Thus, the overall impact depends on quality and emphasis placed on PE within the Educational System.

RESEARCH QUESTION

 

What are the effects of school-based exercise program on physical parameters amongst secondary school children?

 

 

AIM AND OBJECTIVES

 

AIM –

To study the effects of school-based exercise program on physical parameters amongst secondary school children.

 

OBJECTIVES –

PRIMARY OBJECTIVE:

1.     To design and validate School-Based Exercise Protocol for secondary school students.

2.     To study the effect of school-based exercise program on Physical Parameters i.e. Body Mass Index, Muscular Endurance and Aerobic Capacity.

3.     To study the effect of Sedentary Lifestyle in Secondary School Children.

 

SECONDARY OBJECTIVE:

To correlate the effects of school-based exercise program based on factors such as age, gender and lifestyle patterns.

HYPOTHESIS

 

Null Hypothesis (H0) –

There will not be any significant effect of school-based exercise program on physical parameters and lifestyle in secondary school children.

 

Alternative Hypothesis (H1) –

There will be significant effect of school-based exercise program on physical parameters and lifestyle in secondary school children.

MATERIALS AND METHODOLOGY

 

Source of Data – Secondary School in Loni.

 

Study Type – Experimental Study.

 

Study Design – Randomised controlled trial.

 

Study Setting – Secondary School in Loni.

 

Study Population – Secondary School Children between 5th to 10th standards.

 

Study Duration – 2 years.

 

Sample Size – 60 Secondary School Children.

(Calculated using winpepi software)

 

 

SELECTION CRITERIA

 

Inclusion Criteria

1.     Secondary School children between 5th to 10th standards (around 10-15 years of age).

2.     Written and signed consent forms from parents/guardians/teachers.

Exclusion Criteria

1.     Unwilling to participate.

2.     History of any Musculoskeletal Injury or conditions over last 6 months. 

OUTCOME MEASURES

 

The outcome measures used in this study are as follows –

SR NO

Variable Name 

Method of measurement

Statistical Scale 

Descriptive Statistics

1

Aerobic Capacity

Shuttle Walk Test  

Ordinal

Mean ± SD Proportion

2

Muscular Endurance

Curl Up Test

Ordinal

Mean ± SD Proportion

3

Body Mass Index (BMI)

Test

Ordinal

Mean ± SD Proportion

4

Rosenberg Sedentary Lifestyle Questionnaire

Interview

Ordinal

Mean ± SD Proportion

5

Age

Interview

Nominal

Mean ± SD Proportion

6

Gender

Interview

Nominal

Mean ± SD Proportion


PROCEDURE

Phase 1-Ethical Clearance

The synopsis will be submitted to the institutional ethical committee (IEC) and permission will be obtained.

Phase 2-Enrollment of Participants

On getting permission from IEC to carry out the study, participants will be enrolled based on the inclusion and exclusion criteria. Informed content will be taken from guardians/teachers.

 

Phase 3-Data Collection

Participants will be divided into 2 groups, i.e. Experimental Group (n=30) and Control Group (n=30). 

Experimental group will be administered with school-based exercise program, while control group will be given conventional PE exercises conducted during their PE classes.

 

 

Intervention

Group A - Experimental Group:

 

All the instructions for exercise program will be given verbally to the students and they will be provided with demonstrations along with guidance throughout the program.

 

The students will be given the exercise program and will have to perform those exercises within the stipulated time of their PE class for 3 days in 6 weeks.

 

The 3 Physical Parameters i.e. Aerobic Capacity, Muscular Endurance and Body Mass Index will be screened Pre and Post the exercise program.

 

Statistical Analysis will be done and result will be calculated.

 

REFERENCES

 

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5.     Vuori I. Physical inactivity is a cause and physical activity is a remedy for major public health problems. Kinesiology. 2004 Dec 23;36(2):123-53.

6.     Batistão MV, Carnaz L, Moreira RD, Sato TD. Effects of a muscular stretching and strengthening school-based exercise program on posture, trunk mobility, and musculoskeletal pain among elementary schoolchildren-a randomized controlled trial. Fisioterapia em Movimento. 2019 Feb 21;32.

Marwaha RK, Tandon N, Ganie MA, Kanwar R, Shivaprasad C, Sabharwal A, Bhadra K, Narang A. Nationwide reference data for height, weight and body mass 1.    index of Indian schoolchildren. Natl Med J India. 2011 Sep-Oct;24(5):269-77. PMID: 22680077.

 Demetriou, Y., Reimers, A.K., Alesi, M. et al. Effects of school-based interventions on motivation towards physical activity in children and adolescents: protocol for a systematic review. Syst Rev 8, 113 (2019). https://doi.org/10.1186/s13643-019-1029-1

3.     Khadilkar VV, Khadilkar AV, Cole TJ, Chiplonkar SA, Pandit D. Overweight and obesity prevalence and body mass index trends in Indian children. Int J Pediatr Obes. 2011 Jun;6(2-2): e216-24. doi: 10.3109/17477166.2010.541463. Epub 2010 Dec 16. PMID: 21158695.

4.     Dos Santos SF, Bordin D, de Souza EF, Júnior IF. Study protocol and baseline characteristics of “SCHOOL IN ACTION” program on support to physical activity and healthy lifestyles in adolescents. Contemporary Clinical Trials Communications. 2020 Mar 1; 17:100505.

5.     Eime RM, Young JA, Harvey JT, Charity MJ, Payne WR. A systematic review of the psychological and social benefits of participation in sport for children and adolescents: informing development of a conceptual model of health through sport. International journal of behavioral nutrition and physical activity. 2013 Dec;10(1):1-21.

6.     Yuksel HS, Åžahin FN, Maksimovic N, Drid P, Bianco A. School-Based Intervention Programs for Preventing Obesity and Promoting Physical Activity and Fitness: A Systematic Review. Int J Environ Res Public Health. 2020 Jan 3;17(1):347. doi: 10.3390/ijerph17010347. PMID: 31947891; PMCID: PMC6981629.

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