| CTRI Number |
CTRI/2024/02/062359 [Registered on: 07/02/2024] Trial Registered Prospectively |
| Last Modified On: |
06/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
AUTHENTICATE OF PROTOCOL GUIDED PHASE-1 EXERCISE BASED CARDIAC REHABILITATION IN ADULT HEART SURGERIES |
|
Scientific Title of Study
|
VALIDATION OF PROTOCOL GUIDED PHASE-1 EXERCISE BASED CARDIAC REHABILITATION IN ADULT CARDIAC SURGERIES |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
RAJA SHRI R |
| Designation |
MPT STUDENT |
| Affiliation |
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
| Address |
Department of Physiotherapy
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH
NO 1 RAMACHANDRA NAGAR PORUR
CHENNAI-600 116
Chennai
TAMIL NADU
600116
India |
| Phone |
8056672424 |
| Fax |
|
| Email |
rajashrirajaguru21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr T SENTHIL KUMAR |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
| Address |
FACULTY OF PHYSIOTHERAPY
DEPARTMENT OF PHYSIOTHERAPY
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH
PORUR, CHENNAI
Chennai
TAMIL NADU
600116
India |
| Phone |
8248172742 |
| Fax |
|
| Email |
physiotsk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr T SENTHIL KUMAR |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
| Address |
FACULTY OF PHYSIOTHERAPY
DEPARTMENT OF PHYSIOTHERAPY
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH
PORUR,CHENNAI
TAMIL NADU
600116
India |
| Phone |
8248172742 |
| Fax |
|
| Email |
physiotsk@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRI RAMACHANDRA INSTITUTE FOR HIGHER EDUCATION AND RESEARCH
No:1 Ramachandra nagar porur Chennai 600116 |
|
|
Primary Sponsor
|
| Name |
RAJA SHRI R |
| Address |
NO 1 RAMACHANDRA NAGAR PORUR
CHENNAI-600 116 |
| 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 |
| Dr RAJA SHRI R |
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
Department of Cardiovascular and Thoracic surgery( Intensive care unit)
NO 1 RAMACHANDRA NAGAR PORUR
CHENNAI 600 116
Chennai
TAMIL NADU |
8056672424
rajashrirajaguru21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE FOR STUDENTS PROJECTS DHR/ICMR Registration No:EC/NEW/INST/2023/TN/0321 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I708||Atherosclerosis of other arteries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
PATIENT WHO UNDERGONE ADULT CARDIAC SURGERIES
ABLE TO PROVIDE INFORMED CONSENT |
|
| ExclusionCriteria |
| Details |
PATIENTS ASSOCIATED WITH NEUROLOGICAL PROBLEMS
SERIOUS CARDIAC ARRHYTHMIAS
UNABLE TO ENROLL FOR FULL STUDY PARTICIPATION |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Vitals - HR, BP and recovery time before and after each day / stage of mobilisation |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| QUALITY OF LIFE |
4weeks |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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)
|
19/02/2024 |
| 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="0"
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
|
Patient who underwent post operative cardiac surgeries based on the mentioned inclusion and exclusion criteria were selected .patient will be provided with the informed consent and clinical condition will be explained . developed and validated protocol will be c evaluated in the pilot sample for the safety and feasibility by content validation method |