| CTRI Number |
CTRI/2024/07/070592 [Registered on: 15/07/2024] Trial Registered Prospectively |
| Last Modified On: |
06/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Stress risk factors and cardio respiratory fitness in middle class healthy South Indians |
|
Scientific Title of Study
|
Relationship between stress risk factors and cardio respiratory fitness in middle class healthy South Indians-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 |
Mohamed Jesil T |
| Designation |
Master Of Physiotherapy Student |
| Affiliation |
Institute Of Physiotherapy,Srinivas University |
| Address |
Department Of Physiotherapy
Institute Of Physiotherapy
Srinivas University,
Pandeshwar,Mangaluru,Dakshina Kannada
Karnataka
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
8606015872 |
| Fax |
|
| Email |
mohamedjesilt@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.PremKumar |
| Designation |
Associate professor |
| Affiliation |
Institute Of Physiotherapy,Srinivas University |
| Address |
Department of Physiotherapy
Institute Of Physiotherapy
Srinivas University,
Pandeshwar,Mangaluru,Dakshina Kannada
Karnataka
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9442508754 |
| Fax |
|
| Email |
80pk2009@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mohamed Jesil T |
| Designation |
Master Of Physiotherapy student |
| Affiliation |
Srinivas Institute Of Physiotherapy,Srinivas University |
| Address |
Institute Of Physiotherapy
Department of physiotherapy
Srinivas University,
Pandeshwar,Mangaluru,Dakshina Kannada
Karnataka
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
8606015872 |
| Fax |
|
| Email |
mohamedjesilt@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Mohamed Jesil T |
| Address |
Department Of Physiotherapy
Institute Of Physiotherapy,
Srinivas University,Pandeshwar
Dakshina Kannada
Karnataka |
| 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 |
| DrPremkumar |
Srinivas institute of physiotherapy |
Institute Of Physiotherapy
Department of physiotherapy
Srinivas University
Pandeshwar,Mangalore
Dakshina Kannada
KARNATAKA |
9442508754
80pk2009@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRINIVAS UNIVERSITY ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Normal adults |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
• Participants with no known cardiovascular diseases.
• Participants with unidentified psychological symptoms (example: stress, anxiety)
• Participants lying in middle class based on Modified Kuppu-swami Scale (score of 11 to 25) with stable job
• Participants classified as having a low to moderate level of physical activity according to their IPAQ score.
|
|
| ExclusionCriteria |
| Details |
• Participants with diagnosed cardiovascular diseases
• Any history of cardiovascular surgeries
• Any severe musculoskeletal, neurological or psychological conditions in last one year
• Any severe comorbidities/lifestyle disorders30 (Obesity, Diabetes, HTN)
• Individuals who cannot read and write in English language.
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Perceived stress scale
6 Minute Walk Test
IPAQ |
First day and after 1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="385"
Sample Size from India="385"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="385" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/07/2024 |
| Date of Study Completion (India) |
18/07/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
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 titled ’The relationship between stress risk factor and Cardio respiratory fitness in middle class healthy south indians-A cross sectional study’ The study aims to explore the relationship between stress risk factors and Cardio respiratory fitness among middle-class South Indians. Using tools like the Perceived Stress Scale and the six-minute walk test (6MWT), it seeks to identify how stress influences cardiovascular fitness in this demographic. This research is significant for enhancing CVD prevention strategies tailored to the specific challenges faced by middle-class populations in India, promoting a holistic approach to health management. |