| CTRI Number |
CTRI/2024/02/062818 [Registered on: 19/02/2024] Trial Registered Prospectively |
| Last Modified On: |
10/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Methodological study |
| Study Design |
Other |
|
Public Title of Study
|
Development and validation of a tool to assess knowledge and awareness of exercise-induced cardiac events, their prevention and the first response of management in fitness trainers – a methodological study. |
|
Scientific Title of Study
|
Development and validation of a tool to assess knowledge and awareness of exercise-induced cardiac events, their prevention and the first response of management in fitness trainers – a methodological 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 |
Saloni Jain |
| Designation |
PG |
| Affiliation |
Kasturba medical college, Manglore |
| Address |
Department of Physiotherapy, Kasturba Medical College,
Mangalore, Centre for Basic Sciences, Bejai, Mangalore -575 004
Department of Physiotherapy, Kasturba Medical College,
Mangalore, Centre for Basic Sciences, Bejai, Mangalore -575 004
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
8779056554 |
| Fax |
|
| Email |
saloni.mchpmlr2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Ashish John Prabhakar |
| Designation |
Assistant Professor-Selection grade |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
Department of Physiotherapy, Fifth floor, KMC Hospital, Umbedkar
Circle, Mangalore, KARNATAKA, India
Dakshina Kannada
KARNATAKA
575002
India
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
8123223092 |
| Fax |
|
| Email |
ashish.john@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Mr Ashish John Prabhakar |
| Designation |
Assistant Professor-Selection grade |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
Department of Physiotherapy, Fifth floor, KMC Hospital, Umbedkar
Circle, Mangalore, KARNATAKA, India
Dakshina Kannada
KARNATAKA
575002
India
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
8123223092 |
| Fax |
|
| Email |
ashish.john@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Saloni Jain |
| Address |
Department of Physiotherapy, Kasturba Medical College,
Mangalore, Centre for Basic Sciences, Bejai, Mangalore -575 004 |
| 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 |
| Saloni Jain |
Kasturba Medical College |
Department of Physiotherapy, Fifth floor, KMC Hospital, Ambedkar
Circle, Mangalore, KARNATAKA, India
Dakshina Kannada
KARNATAKA
575002
India
Dakshina Kannada
KARNATAKA |
8779056554
saloni.mchpmlr2023@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Kasturba Medical College, Mangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy individuals (Fitness Trainers) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Fitness Trainers |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| assessment of awareness and knowledge |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
23/02/2024 |
| 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="0"
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
|
Recent evidence states that there has been an increase in exercise related SCA during recent years among the gym going population, thereby increasing the concern about emergency medical services in such situations. Life threatening situations may occur anytime in the gym, in such cases fitness trainers are the first point of contact with the subject. Therefore, there is dearth of literature about basic life support in fitness trainers in spite of the increasing incidences of sudden exercise-related gym collapses. Hence it becomes imperative to know about the awareness of cardiac events, their prevention, and first response of management in fitness trainers. With the above background, the present study is being undertaken to construct a tool that will assess knowledge, and awareness of cardiac events, their prevention, and the first response of management in fitness trainers. |