| CTRI Number |
CTRI/2024/07/070653 [Registered on: 15/07/2024] Trial Registered Prospectively |
| Last Modified On: |
09/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To find out and to aim at energy consumption in individuals suffering with heart disease and individuals without heart disease of the same age group. |
|
Scientific Title of Study
|
Energy Expenditure In Individuals With And Without Coronary Artery Disease |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sunil Veerkar |
| Designation |
Post graduate student |
| Affiliation |
SDM College Of Physiotherapy |
| Address |
OPD no 13, Department of Cardio-respiratory disorders, SDM College Of Physiotherapy, Manjushree nagar, Sattur, Dharwad, Karnataka 580009, India
OPD no 13, Department of Cardio-respiratory disorders, SDM College Of Physiotherapy, Manjushree nagar, Sattur, Dharwad, Karnataka 580009, India
Dharwad
KARNATAKA
580009
India |
| Phone |
8553381638 |
| Fax |
|
| Email |
sunilveerkar173@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sunil Veerkar |
| Designation |
Post graduate student |
| Affiliation |
SDM College Of Physiotherapy |
| Address |
OPD no 13, Department of Cardio-respiratory disorders, SDM College Of Physiotherapy, Manjushree nagar, Sattur, Dharwad, Karnataka 580009, India
OPD no 13, Department of Cardio-respiratory disorders, SDM College Of Physiotherapy, Manjushree nagar, Sattur, Dharwad, Karnataka 580009, India
Dharwad
KARNATAKA
580009
India |
| Phone |
8553381638 |
| Fax |
|
| Email |
sunilveerkar173@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sangeeta Appannavar |
| Designation |
Associate Professor and PG Guide |
| Affiliation |
SDM College Of Physiotherapy |
| Address |
OPD no 13, Department of Cardio-respiratory disorders, SDM College Of Physiotherapy, Manjushree nagar, Sattur, Dharwad, Karnataka 580009, India
OPD no 13, Department of Cardio-respiratory disorders, SDM College Of Physiotherapy, Manjushree nagar, Sattur, Dharwad, Karnataka 580009, India
Dharwad
KARNATAKA
580009
India |
| Phone |
9591753487 |
| Fax |
|
| Email |
sangeeta.appannavar@sdmuniversity.edu.in |
|
|
Source of Monetary or Material Support
|
| SDM College Of Physiotherapy Manjushree Nagar, Sattur, Dharwad-580009, Karnataka,
India. |
|
|
Primary Sponsor
|
| Name |
Sunil Veerkar |
| Address |
SDM College Of Physiotherapy
SDM College Of Medical Sciences And Hospital Manjushree Nagar Sattur Dharwad Karnataka 580009 |
| 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 |
| Sunil Veerkar |
Shri Dharmasthala Manjunatheshwara hospital |
Cardiorespiratory Department OPD no 13 Manjushree Nagar Sattur Dharwad Karnataka
Dharwad
KARNATAKA |
8553381638
sunilveerkar173@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-SDM College Of Medical Sciences And Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I240||Acute coronary thrombosis not resulting in myocardial infarction, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age – 40 to 60 years.
All genders
Individuals diagnosed with CAD by medicine
Physicians/Cardiologists.
Smokers and nonsmokers
Individuals with hypertension and diabetes |
|
| ExclusionCriteria |
| Details |
Individuals with unstable angina, neurological
deficits, and lower limb amputation.
Individuals undergoing angioplasty and CABG.
Individuals with a history of heart attack 1-2 months before.
Individuals who are on psychological medication and are psychologically unstable.
Individuals with any Orthopedic and Neurologic
problems that hinder walking. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Physiological cost index |
outcome measures are taken after completion of the 6-minute walk test |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Borgs rate of perceived exertion |
Scale is taken after completion of Minutes walk |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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)
|
08/08/2024 |
| 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 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
|
The primary purpose of the study is to calculate the energy expenditure of walking in individuals with coronary artery disease and in individuals without coronary artery disease using the Physiological cost index and to notice the exertion level after completion of the 6-minute walk test rate of perceived exertion is quantified using Borg`s rate of perceived exertion scale. |