| CTRI Number |
CTRI/2024/06/068897 [Registered on: 13/06/2024] Trial Registered Prospectively |
| Last Modified On: |
07/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Calculating the Anthropometric Measures and Jumping Abilities of Physically Active School-going Children and Adolescents |
|
Scientific Title of Study
|
Normative values of Vertical and Horizontal jump test and its correlation with Anthropometric measures among the physically active school going children and adolescents |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aishwarya Sonwane |
| Designation |
Assisstant Professor |
| Affiliation |
Institute of Physiotherapy, Srinivas University |
| Address |
Institute of Physiotherapy, Srinivas University, City Campus Pandeshwar, Mangalore, Karnataka, India
Dakshina Kannada KARNATAKA 575001 India |
| Phone |
09011969806 |
| Fax |
|
| Email |
aishwaryasonwane@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ajay Kumar |
| Designation |
Professor |
| Affiliation |
Institute of Physiotherapy, Srinivas University |
| Address |
Institute of Physiotherapy, Srinivas University, City Campus Pandeshwar, Mangalore, Karnataka, India
Dakshina Kannada KARNATAKA 575001 India |
| Phone |
9011959806 |
| Fax |
|
| Email |
drajay@srinivasuniversity.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Ajay Kumar |
| Designation |
Professor |
| Affiliation |
Institute of Physiotherapy, Srinivas University |
| Address |
Institute of Physiotherapy, Srinivas University, City Campus Pandeshwar, Mangalore, Karnataka, India
Dakshina Kannada KARNATAKA 575001 India |
| Phone |
9011959806 |
| Fax |
|
| Email |
drajay@srinivasuniversity.edu.in |
|
|
Source of Monetary or Material Support
|
|
Srinivas University, Institue of Physiotherapy, City Campus, Pandeshwar, Mangalore -575001 Karnataka India |
|
|
Primary Sponsor
|
| Name |
Aishwary Nitin Sonwane |
| Address |
Institute of Physiotherapy, Srinivas University, City Campus Pandeshwar, Mangalore |
| Type of Sponsor |
Other [Self] |
|
|
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 Aishwarya Nitin Sonwane |
Institute of Physiotherapy Srinivas University |
Ground floor, Department of Physiotherapy Dakshina Kannada KARNATAKA |
09011969806
aishwaryasonwane@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Srinivas University Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy children and adolescents |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
1. School-going Children and adolescents in the age range of 6 to 17.
2. PAQ-C/A scores of >2.9 for boys and >2.7 for girls.
3. Appropriate approval with assent and consent from parents and the head of the school.
4. Ability to understand and comprehend the requirements for the introduction of the
testing methods. |
|
| ExclusionCriteria |
| Details |
1. Any acute illness.
2. Any diagnosed pulmonary, cardiovascular, neurological, or any systemic illness that
prohibits them from participating in physical activity.
3. Recent musculoskeletal injuries which limit them from participating in physical
education classes and sports activities.
4. Any congenital abnormalities/deformities confined to lower extremities.
5. History of hospitalization in the past 3-6 months.
6. Any current medications that impair the physical performance. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Vertical Jump test
2. Horizontal Jump test |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Physical Activity Questionnaire for children
2. Physical Activity Questionnaire for Adolescents
3. Anthropometric Measures |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="725" Sample Size from India="725"
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)
|
10/07/2024 |
| 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="6" 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
|
The Physically Active School-Going Children and Adolescents were targeted in this study to generate the Normative values of the Vertical Jump test and Horizontal Jump test. After the Doctoral Committee meeting presentation, Institutional Ethical Approval will be obtained from Srinivas University, Mangaluru. An application seeking permission will be sent to the District Education Board (Block education officer) to carry out the Body composition and jumping ability test with proper explanation and demonstration in school-going children, then forwarded to the Head of the Schools/Institutes in urban Mangaluru. An Assent form from parents and a Consent form with the description and importance of the test will be obtained from children and adolescents respectively. Multistage Cluster Sampling will be done (as discussed above) for 725 participants, rounded up to 732 (366 boys and 366 girls), in the age range of 6 to 17 years. There will be a formal discussion with the head of the school and physical education teacher regarding the planning and schedule to fix the timings for the participation and testing sessions. After permission is obtained from the head of the school/institution all the students in class will undergo demographic screened (including personal and school details) where the levels of physical activity will be checked by using PAQ-C and PAQ-A for children and adolescents respectively, followed by inclusion and exclusion criteria and once they meet the section criteria the data collection starts. A proper explanation, instructions, and demonstration regarding tests will be given so that the vertical jump test and standing broad jump test procedures will be commenced. The instructions before the test include loose and comfortable clothing, they should be barefoot, for better understanding they will have a warmup trial and then will jump three times per test, with a minimum interval of 45 seconds between the jumps, and the highest value will be recorded. |