| CTRI Number |
CTRI/2024/08/073085 [Registered on: 29/08/2024] Trial Registered Prospectively |
| Last Modified On: |
27/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Cardiovascular Diseases Risk Factors Among Students |
|
Scientific Title of Study
|
Evaluation of Knowledge and Risk Factors of Cardiovascular Disease Among Non-Medical College Students: A Cross-Sectional Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amogh Mani Risal |
| Designation |
Post-graduate student |
| Affiliation |
Sikkim Manipal College of Physiotherapy |
| Address |
Central Referral Hospital, Department of Physiotherapy, 5th Mile Tadong, Gangtok, East Sikkim, Sikkim, India
East
SIKKIM
737102
India |
| Phone |
917811031616 |
| Fax |
|
| Email |
Amogh_202304009@smims.smu.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prabin Pradhan |
| Designation |
Lecturer |
| Affiliation |
Sikkim Manipal College of Physiotherapy |
| Address |
Central Referral Hospital, Department of Physiotherapy, 5th Mile Tadong, Gangtok, East Sikkim, Sikkim, India
East
SIKKIM
737102
India |
| Phone |
917848985490 |
| Fax |
|
| Email |
Prabin.p@smims.smu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Amogh Mani Risal |
| Designation |
Post-graduate student |
| Affiliation |
Sikkim Manipal College of Physiotherapy |
| Address |
Central Referral Hospital, Department of Physiotherapy, 5th Mile Tadong, Gangtok, East Sikkim, Sikkim, India
East
SIKKIM
737102
India |
| Phone |
917811031616 |
| Fax |
|
| Email |
Amogh_202304009@smims.smu.edu.in |
|
|
Source of Monetary or Material Support
|
| Central Referral Hospital Department Of Physitherapy, 5th Mile Upeer Tadong Gangtok East Sikkim, India-737102 |
|
|
Primary Sponsor
|
| Name |
Central Refrerral Hospital |
| Address |
Central Refrerral Hospital, Canara Bank, 5th Mile Tadong, GHangtok East Sikkim,737102 |
| Type of Sponsor |
Other [Nil] |
|
|
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 Amogh Mani Risal PT |
Central Referral Hospital |
Central Referral Hospital, Department of Physiotherapy,Level 05, 5th Mile Tadong, East Sikkim, Gangtok, India
East
SIKKIM |
7811031616
Amogh_202304009@smims.smu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMIMS INSTITUTION ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Apparently healthy human being |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1. Non-medical college students
2. All genders
|
|
| ExclusionCriteria |
| Details |
1. Diagnosed case of cardiovascular diseases
2. Recent fractures impeding standing
3. Unwilling to participate
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Bioelectric Impedance Analysis (BIA)
2. Anthropometric measurement
3. Blood pressure (SBP & DBP)
4. International Physical Activity Questionnaire- Short Form (IPAQ-SF)
5. Heart Disease Fact Questionnaire (HDFQ)
|
One Time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="315"
Sample Size from India="315"
Final Enrollment numbers achieved (Total)= "315"
Final Enrollment numbers achieved (India)="315" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
11/09/2024 |
| Date of Study Completion (India) |
19/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
19/03/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| 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
|
Purpose of the study:
This research study aims to find the level of knowledge on cardiovascular disease and its risk factors
among non-medical college going students.
Who can take part in this study:
All the college-going non-medical students who fulfils the inclusion criteria will be requested to take part
in the study.
What will happen during the study?
First, I will explain my study in the language of your understanding. Once you have consented to be a
participant in my study, I will evaluate you based on my inclusion and exclusion criteria. Once I have
evaluated you based on my eligibility criteria to make you a participant in my study, we will start with the
study. Firstly, body composition will be assessed using the BIA (body mass index, total body fat, visceral
fat, subcutaneous body fat, and skeletal muscle mass). Hip and waist circumferences will be measured using
measuring tape (waist hip ratio). Then blood pressure will be measured using a manual sphygmomanometer,
level of physical activity will be assessed using the IPAQ questionnaire, and knowledge of cardiovascular
disease will be assessed using the HDFQ questionnaire. Finally, the data will be analysed and disseminated.
The time duration to complete the test will be approximately 10-13 minutes. The complete intervention will
be administered once to every individual who is deemed qualified to take part in this study.
What are the risks and discomfort?
There are no risks involved in this study.
Benefits to the participant:
There is no direct benefit to the participants, but they will be screened for high, moderate, and low levels
of developing cardiovascular disease. Individuals at high risk of developing cardiovascular disease will be
given advice regarding their modifiable risk factors. The level of physical fitness will be analysed, and the
current level of blood pressure and knowledge regarding cardiovascular disease will also be identified.
Compensation for injury:
There shall be no incentives or remuneration for the data collected from you. Moreover, all the
physiotherapy tests related to the study will be free of charge.
Confidentiality of information:
On completion of this study, all your personal details will be made anonymous to ensure the confidentiality
of your participation. After enrolment in this research study, you are requested to follow only the procedure
protocol instructed or demonstrated. Non-compliant study subjects during the procedure may have to be
dropped from this study by the investigator.
Right to withdraw from study:
It is expected that there will be cooperation and voluntary participation by the patient or patient party in this
study. If you want to withdraw from the study, you have the right to do so. No questions will be asked. The
standard treatment of care shall not be denied to you in case you have decided to withdraw from the study. |