| CTRI Number |
CTRI/2025/03/082747 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
17/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Exercises for heart surgery patients at Home versus at Centers |
|
Scientific Title of Study
|
Effect of Exercise based Hybrid Mode of Cardiac Rehabilitation on body composition, Vascular stiffness, Functional capacity and Quality of Life after Adult Surgical Revascularization-A Randomized Controlled trial. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
AJITH KUMAR P |
| Designation |
Lecturer |
| Affiliation |
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH (DU) |
| Address |
Room 1.1, Department of cardiopulmonary physiotherapy, Sri Ramachandra Faculty of Physiotherapy, Sri Ramachandra Institute of Higher Education and Research (DU), No.1 Ramachandra Nagar, Porur.
Chennai
TAMIL NADU
600116
India |
| Phone |
09087350257 |
| Fax |
|
| Email |
AJIPHYSIO08@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
AJITH KUMAR P |
| Designation |
Lecturer |
| Affiliation |
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH (DU) |
| Address |
Room 1.1, Department of cardiopulmonary physiotherapy, Sri Ramachandra Faculty of Physiotherapy, Sri Ramachandra Institute of Higher Education and Research (DU), No.1 Ramachandra Nagar, Porur.
Chennai
TAMIL NADU
600116
India |
| Phone |
09087350257 |
| Fax |
|
| Email |
AJIPHYSIO08@GMAIL.COM |
|
Details of Contact Person
Public Query
|
| Name |
AJITH KUMAR P |
| Designation |
Lecturer |
| Affiliation |
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH (DU) |
| Address |
Room 1.1, Department of cardiopulmonary physiotherapy, Sri Ramachandra Faculty of Physiotherapy, Sri Ramachandra Institute of Higher Education and Research (DU), No.1 Ramachandra Nagar, Porur.
Chennai
TAMIL NADU
600116
India |
| Phone |
09087350257 |
| Fax |
|
| Email |
AJIPHYSIO08@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Institute of Higher Education and Research (Deemed to be University),
No.1 Ramachandra Nagar
Porur, Chennai - 600 116
Tamil Nadu, India. |
|
|
Primary Sponsor
|
| Name |
Ajith Kumar P |
| Address |
No.1, Sri Ramachandra Nagar, Porur, Chennai- 600116 |
| Type of Sponsor |
Other [Self-Funding] |
|
|
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 |
| AJITH KUMAR P |
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH (DEEMED TO BE UNIVERSITY) |
Room 1.1, Department of Cardiopulmonary Physiotherapy, Sri Ramachandra Faculty of Physiotherapy
Chennai
TAMIL NADU |
9087350257
ajithkumarp@sriramachandra.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Ramachandra Institute of Higher Education and Research (deemed to be university) Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I251||Atherosclerotic heart disease of native coronary artery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Exercise based Hybrid cardiac rehabilitation |
Duration - 24 weeks
Education and Training about
I. Safety precaution
II. Self Vitals monitoring
III. Education and behavioural modifications
IV. Exercise training methods
V. Exercise training supports
Remote Cardiac rehabilitation with Weekly reminders and Doubt clarifications, Monthly meetings at centre.
|
| Comparator Agent |
Traditional exercise cardiac rehabilitation |
Duration - 24 weeks
Routine Exercise and Education of patients.
Centre based Cardiac Rehabilitation.
under supervision. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Post operative coronary artery bypass grafting patients |
|
| ExclusionCriteria |
| Details |
High risk patients as per AHA and AACVPR guidelines,
Severe uncontrolled medical conditions, renal disease, liver disease, cerebrovascular insults
Neurological disorders, Severe respiratory conditions
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Carotid Artery Intima Media Thickness with Ultrasonography in 0.50-0.80mm
2.Body Composition -i35 Mediana
3.Functional capacity with 6minute walk test distance
4.Quality of Life with sf-36
5.Framingham Risk score |
1.Carotid Artery Intima Media Thickness with Ultrasonography in 0.50-0.80mm
2.Body Composition -i35 Mediana |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Functional capacity with 6minute walk test distance
2. Quality of Life with sf-36 3. Framingham Risk score |
Predischarge-Baseline, 3months and 6months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/05/2025 |
| 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)
|
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
|
Develop a feasible, user-friendly and effective technology-based platform (App) for Phase II training Analyse the effects of hybrid mode cardiac rehabilitation on the body fat composition and vascular stiffness Determine the effects of phase II cardiac rehabilitation in hybrid mode on the quality of life and functional capacity Compare the exercise compliance and client satisfaction between the traditional and hybrid mode Cardiac rehabilitation |