| CTRI Number |
CTRI/2025/08/092992 [Registered on: 13/08/2025] Trial Registered Prospectively |
| Last Modified On: |
21/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Physical Exercise] |
| Study Design |
Other |
|
Public Title of Study
|
Improving Physical Fitness of Emergency Medical Technicians through a Strength Training Program |
|
Scientific Title of Study
|
Evaluating the effect of strengthening workout program on EMTs physical performance |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Joylin Nathalian Dsouza |
| Designation |
Post graduate student |
| Affiliation |
Manipal College of Health Professions MAHE Manipal |
| Address |
Department of Emergency Medical Technology Manipal College of Health Professions MAHE Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8197677482 |
| Fax |
|
| Email |
joylin.mchpmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sachin Nayak Sujir |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College and Hospital MAHE Manipal |
| Address |
Department of Emergency Medicine Kasturba Medical College and Hospital MAHE Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9449111397 |
| Fax |
|
| Email |
sachin.sujir@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sachin Nayak Sujir |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College and Hospital MAHE Manipal |
| Address |
Department of Emergency Medicine Kasturba Medical College and Hospital MAHE Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9449111397 |
| Fax |
|
| Email |
sachin.sujir@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Emergency Medical Technology Manipal College of Health Professions Manipal Academy of Higher Education Manipal Udupi Karnataka India 576104 |
|
|
Primary Sponsor
|
| Name |
Manipal College of Health Professions Manipal Academy of Higher Education |
| Address |
Manipal College of Health Professions Madhava Nagar Manipal Udupi Karnataka 576104 |
| 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 Sachin Nayak Sujir |
Manipal College of Health Professions Manipal |
Department of Emergency Medical Technology Manipal College of Health Professions Manipal Academy of Higher Education Manipal
Udupi
KARNATAKA |
9449111397
sachin.sujir@manipal.edu |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normal Healthy Human |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
6-Week Structured Strengthening Exercise Program for EMTs |
The study will be explained to all participants and informed consent will be obtained and A physical simulation test and a pre-training questionnaire will be conducted before starting the intervention and Participants will then undergo a 6-week strengthening workout program with vitals checked before and after each session and Each session will last 1 hour conducted twice a week and The training will take place at the Interact building ground floor Near tiger circle bus stop Manipal Udupi Karnataka India 576104 and refreshments will be provided after each session and After completing the program a post-training physical simulation test and questionnaire will be conducted to evaluate the impact of the intervention |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
UG PG Staff faculties of Emergency medical technology from MCHP Manipal
Age range More than 18 years
Both Male and Female
|
|
| ExclusionCriteria |
| Details |
Musculoskeletal injury that restricts exercise
Any restrictive airway disease
Any Surgery in the past 1 year
Blood dyscrasias
Pregnant women
Baseline vitals Blood pressure more than 140 by 90mmhg and heart rate more than 100bpm
Anyone with a cardiac disorder |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improved physical performance and enhanced task efficiency improvement in strength and overall physical capability of EMT as assessed by the physical simulation test after the physical strengthening program
Correlation between strength training and physical performance
Recommendation for inclusion of structured strength training in EMT curriculum to improve job performance |
7 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
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)
|
08/09/2025 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The study will be conducted after obtaining IRC and IEC approval and CTRI registration. The study will be explained to all participants and informed consent will be obtained. A physical simulation test and a pre-training questionnaire will be conducted before starting the intervention, and Participants will then undergo a 6-week strengthening workout program with vitals checked before and after each session. The training will take place at the Interact building, ground floor, Manipal, and refreshments will be provided after each session. After completing the program, a post-training physical simulation test and questionnaire will be conducted to evaluate the impact of the intervention. Acquired data will be analyzed by JAMOVI statistics software version 2.6.25. Following approval of the IEC amendment, a control group has been included to strengthen the study design. The intervention phase has already been completed, and the study will now proceed with recruitment and assessment of the control group. The total sample size will remain the same as initially approved. Participants will be divided into intervention and control groups for analysis, with the intervention group data already collected and the control group continuing routine activities without any intervention. Additionally, the study title has been corrected from “EMT” to “Emergency Medical Technologist” (Title: Evaluating the effect of strengthening workout program on Emergency Medical Technologist physical performance). The study period has been extended till 30-06-2026, and the co-guide Ms. Lavanya BN has been removed as per the approved amendment. |