| CTRI Number |
CTRI/2025/12/099092 [Registered on: 15/12/2025] Trial Registered Prospectively |
| Last Modified On: |
11/12/2025 |
| 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
|
Effect of fast and quick exercises on physical fitness in untrained obese school going
adolescents |
|
Scientific Title of Study
|
Effect of plyometric exercise on physical fitness in untrained obese school going
adolescents |
| Trial Acronym |
FITS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyanka Amit Kumar |
| Designation |
PhD Research Scholar |
| Affiliation |
Garden City University |
| Address |
Garden City University,16th KM ,Old Madras Road, Bangalore Garden City University ,16th KM,Old Madras Road, Bangalore 560049 Bangalore KARNATAKA 560049 India |
| Phone |
9900262171 |
| Fax |
|
| Email |
baghla.priyanka@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. Senthikumar Natarajan |
| Designation |
Guide |
| Affiliation |
Garden City University |
| Address |
Garden City University ,16th KM,Old Madras Road, Bangalore 560049 Garden City University ,16th KM,Old Madras Road, Bangalore 560049 Bangalore KARNATAKA 560043 India |
| Phone |
7010340650 |
| Fax |
|
| Email |
senthilkumar.n@gcu.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Priyanka Amit Kumar |
| Designation |
PhD Research Scholar |
| Affiliation |
Garden City University |
| Address |
Garden City University ,16th KM,Old Madras Road, Bangalore 560049 Garden City University ,16th KM,Old Madras Road, Bangalore 560049 Bangalore KARNATAKA 560049 India |
| Phone |
9900262171 |
| Fax |
|
| Email |
baghla.priyanka@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Priyanka Amit Kumar |
| Address |
2143, B wing, Prestige North Point, Kammanhalli Main Road, HRBR layout, Above Westside , Bangalore |
| Type of Sponsor |
Other [PhD reserach Scholar] |
|
|
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 |
| Priyanka Amit Kumar |
Gcu Physio care |
Physiotherapy clinic, Kithaganur Main Road, TC palya, Battarhalli, Bangalore Bangalore KARNATAKA |
09900262171
baghla.priyanka@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GCU-institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Obese |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control |
The participants will carry on day to day activites |
| Intervention |
Pliometric exercises |
Intervention Protocol
The plyometric training group will perform exercises twice a week for 60 minutes per session, on non-consecutive days, over 8 weeks. Training intensity will progressively increase and include:
1. Low-Intensity Exercises: Lateral jumps.
2. Moderate-Intensity Exercises: Squat jumps.
3. High-Intensity Exercises: Jumping at progressively increasing heights.
Participants will train under the supervision of qualified instructors to ensure proper technique and safety. All participants will attend an introductory session before baseline assessments. During this session:
1. Researchers will explain the procedures to participants and guardians.
2. Demonstrations of each test and exercise will be provided by trained assistants.
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Age Range: Adolescents aged 10 to 16 years. (It was suggested to make age groups. 10 to 12
years, 12 to 14 years. 14 to 16 years)
2. Waist to hip ratio: if more than .9
3. BMI Classification: A BMI that is less than the 5th percentile is considered underweight and
above the 95th percentile is considered obese. Children with a BMI between the 85th and
95th percentile are considered to be overweight. Physical Capacity: Participants who are
willing to engage in physical exercise, especially plyometric training.
4. Willingness to Participate: Adolescents and their legal guardians must provide written
informed consent.
5. Sedentary Lifestyle: Adolescents with low levels of physical activity or who do not engage
in regular exercise programs (defined as less than 60 minutes of moderate-to-vigorous
activity on most days). Physical Activity Questionnaire for Indian Children and Adolescents |
|
| ExclusionCriteria |
| Details |
Diagnosed Diabetes: Adolescents who have been diagnosed with Type 1 or Type 2
diabetes.
2. Significant Musculoskeletal Injuries: Adolescents with musculoskeletal injuries or
orthopedic issues that would prevent safe participation in plyometric exercises.
3. Chronic Illnesses: Any chronic conditions such as cardiovascular disease, severe
asthma, or kidney disease that could make exercise unsafe.
4. Current Participation in Structured Exercise Programs:
5. Use of Medications Affecting Metabolism: Adolescents taking medications such as
steroids, metformin, or other medications that significantly affect metabolic parameters.
6. Mental Health Conditions: Adolescents with mental health or behavioral conditions that
could impact their ability to adhere to the exercise program or the study protocol (e.g.,
severe ADHD, uncontrolled depression). |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Anthropometric and Body Composition Measurements:
o Height and weight.
o BMI calculated as weight (kg) divided by height (m²).
2. For cardiovascular: 6 minutes’ walk test
3. Hand grip strength
o Dynamometer |
at 0 week, at 8th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="94" Sample Size from India="94"
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)
|
31/12/2025 |
| 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="0" 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 - NO
|
|
Brief Summary
|
Childhood obesity has become a pressing public health issue worldwide, and India is no exception. Once considered a problem of affluent nations, obesity among Indian children has escalated dramatically in recent decades, presenting significant challenges to individual health, healthcare systems, and societal well-being. Beyond its immediate consequences on physical health and well-being, childhood obesity predisposes individuals to a myriad of long-term health complications, including metabolic disorders like diabetes and pre diabetes, cardiovascular disease, respiratory dysfunction, and musculoskeletal impairments. Body Mass Index (BMI) and Waist-to-Hip Ratio (WHR) are critical indicators in assessing obesity and related health risks in children. BMI categorizes weight relative to height, identifying individuals as underweight, normal weight, overweight, or obese. In children, a BMI between the 5th and 85th percentiles is generally associated with a healthy weight range, while those classified as overweight (at or above the 85th percentile) or obese (at or above the 95th percentile) face greater health risks related to excess body fat. In particular, obese children are more likely to experience metabolic imbalances and chronic inflammation, which are common complications of obesity. Regular monitoring of BMI is essential to detect these risks early and initiate interventions, such as promoting healthier dietary habits and increased physical activity, to support weight management in this vulnerable population. The Waist-to-Hip Ratio (WHR) is also an important measure for assessing obesity-related risks, as it reflects central fat distribution, which is more strongly associated with metabolic health than overall body fat. WHR is calculated by dividing the waist circumference by the hip circumference, providing insight into fat distribution within the body. A high WHR indicates an accumulation of visceral fat, a key factor in obesity-related metabolic disruptions. Monitoring WHR in children enables the early identification of obesity-related health risks and can guide lifestyle interventions that promote healthier eating habits and increased physical activity to mitigate the long-term effects of obesity. Plyometric exercises, which involve rapid and repeated stretching and contracting of muscles, are recognized for their potential to enhance strength, coordination, and muscle power. Incorporating plyometric exercises may offer a novel approach to improving physical fitness and reducing obesity-related risks in adolescents. However, while aerobic and resistance exercises have been widely studied for their effects on BMI and WHR, limited research exists on how plyometric exercises specifically benefit obese adolescents. The majority of studies on plyometric training focus on athletes or individuals with a normal weight, leaving a gap in understanding its impact on those who are obese. |