| CTRI Number |
CTRI/2024/11/077463 [Registered on: 28/11/2024] Trial Registered Prospectively |
| Last Modified On: |
21/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
The strength and stamina of core muscles in students aged 18 to 25 from different fields of study. |
|
Scientific Title of Study
|
Core muscle Endurance in 18 to 25 year old Students from different fields of Education |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ruqaiya Ameen |
| Designation |
Intern |
| Affiliation |
KLE Institute of Physiotherapy |
| Address |
Ground Floor of Plot No. 134, CTS No. 4857/138, II Main, Crescent Building, Sadashiv Nagar, Belagavi
Belgaum
KARNATAKA
590001
India |
| Phone |
7411707253 |
| Fax |
|
| Email |
ruqaiya239@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr VarshaHuddar |
| Designation |
Professor and Head Department Of Biomechanics |
| Affiliation |
KLE Institute of Physiotherapy |
| Address |
Advanced Physiotherapy Center,Opd no 12 Department Of Biomechanics Sagar Floor KLEs Dr Prabhakar Kore Hospital and MRC Nehru Nagar 590010 Belgavi Karnataka
Advanced Physiotherapy Center,Opd no 12 Department Of Biomechanics Sagar Floor KLEs Dr Prabhakar Kore Hospital and MRC Nehru Nagar 590010 Belgavi Karnataka
Belgaum
KARNATAKA
590001
India |
| Phone |
9880733370 |
| Fax |
|
| Email |
drvarshabadli@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr VarshaHuddar |
| Designation |
Assistant Professor |
| Affiliation |
KLE Institute of Physiotherapy |
| Address |
Advanced Physiotherapy Center,Opd no 12 Department Of Biomechanics Sagar Floor KLEs Dr Prabhakar Kore Hospital And MRC Nehru Nagar590010 Belagavi Karnataka
Advanced Physiotherapy Center,Opd no 12 Department Of Biomechanics Sagar Floor KLEs Dr Prabhakar Kore Hospital And MRC Nehru Nagar590010 Belagavi Karnataka
Belgaum
KARNATAKA
590001
India |
| Phone |
9880733370 |
| Fax |
|
| Email |
drvarshabadli@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Biomechanics, KLE Hospital, JNMC Campus, Nehru Nagar, Belagavi, Karnataka, India- 590001 |
|
|
Primary Sponsor
|
| Name |
KAHER Institute Of Physiotherapy |
| Address |
Department of Biomechanics, KLE Hospital, JNMC Campus, Nehru Nagar, Belagavi, Karnataka, India- 590001 |
| 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 |
| Dr Varsha Huddar |
KLE Institute of Physiotherapy |
Department of Biomechanics Physiotherapy,Physiotherapy OPD, K.L.E Institute of Physiotherapy, Medical College Campus, JN, Nehru Nagar, Belagavi (590001), Karnataka, India
Belgaum
KARNATAKA |
9880733370
drvarshabadli@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Resarch And Ethical Committee KLEU Institute of Physiotherapy Belgavi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Core muscle strenght |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
medical college students- MBBS, Dental, Pharmacy, Physiotherapy, Nursing, Ayurveda and Homeopathy students.non-medical college students- Engineering, Commerce, Arts and Law students.
|
|
| ExclusionCriteria |
| Details |
- History of injury to back and abdomen such as spine fracture 6 months back.
- Low back pain since 1 month
- Any systemic illness that prevent the participant from doing the test.
- Athletes or students participating in physical activity.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
BIERING SORENSEN TEST
PRONE PLANK TEST
SIDE BRIDGE ENDURANCE TEST |
one time observation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Questionnaire for other related information |
one time observation |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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)
|
25/12/2024 |
| 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="0"
Months="6"
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
|
Introduction- Core muscles stabilizes the body and spine with and without limb movement and maintains postural alignment. Weak core lead to excessive load on lumbar spine, back and lower extremities, which leads to various musculoskeletal disorders.
Objectives- To determine the prevalence and compare the core muscle weakness in the 18 -25 years old medical and non medical students using Biering Sorensen test, Prone Plank test and Side bridge endurance test.
Inclusion Criteria- -Students between age group of 18-25 years old who are willing to participate. -Streams included for medical college students- MBBS, Dental, Pharmacy, Physiotherapy, Nursing, Ayurveda and Homeopathy students. -Streams included for non-medical college students- Engineering, Commerce, Arts and Law students.
Exclusion Criteria- - History of injury to back and abdomen such as spine fracture 6 months back. - Low back pain since 1 month - Any systemic illness that prevent the participant from doing the test. - Athletes or students participating in physical activity.
Procedure- Name of all the colleges in the Belagavi city will be collected from the District office. 2 clusters will be made of north and south Belagavi. From each cluster 2 medical and 2 non medical college will be randomly selected using computer software. Permission will be obtained from the Principals of the respective colleges. Participants will be screened based on the inclusion and the exclusion criteria. The purpose of the study will be explained and a written informed consent will be obtained from all the participants. A brief demographic data and past history will be obtained from the participants prior to the assessment. Participants will perform three trials of the each outcome measure test with adequate rest period between the test. The data will be collected, tabulated and analyzed. Descriptive statistics will be done. Chi square test will be used. The statistical significance will be set at 5%level (p<0.05).
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