| CTRI Number |
CTRI/2026/02/104879 [Registered on: 26/02/2026] Trial Registered Prospectively |
| Last Modified On: |
20/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA)
Behavioral
Other (Specify) [Cardiac rehabilitation] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study to Assess the Effect of a Home-Based Exercise Program on Recovery and Quality of Life in Patients with Heart Disease |
|
Scientific Title of Study
|
An analysis of the feasibility and effectiveness of Home-Based Cardiac Rehabilitation using virtual Interactive Tele-Rehabilitation Platform ITRP CardiRehab in patients with coronary artery disease A Randomized control 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 |
Aditya John Binu |
| Designation |
Assistant Professor |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Department of Cardiology,
CMC Vellore Ranipet Campus
Doctors quarters, CMC Vellore Town Campus, Ida Scudder Road,
Vellore-632004
Vellore
TAMIL NADU
632517
India |
| Phone |
9940789083 |
| Fax |
|
| Email |
adityabinu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aditya John Binu |
| Designation |
Assistant Professor |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Department of Cardiology,
CMC Vellore Ranipet Campus
Doctors quarters, CMC Vellore Town Campus, Ida Scudder Road,
Vellore-632004
TAMIL NADU
632517
India |
| Phone |
9940789083 |
| Fax |
|
| Email |
adityabinu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aditya John Binu |
| Designation |
Assistant Professor |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Department of Cardiology,
CMC Vellore Ranipet Campus
Doctors quarters, CMC Vellore Town Campus, Ida Scudder Road,
Vellore-632004
TAMIL NADU
632517
India |
| Phone |
9940789083 |
| Fax |
|
| Email |
adityabinu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Christian Medical College Vellore |
|
|
Primary Sponsor
|
| Name |
Christian Medical College Vellore |
| Address |
Christian Medical College Vellore,
Vellore-632004, Tamil Nadu |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Aditya John Binu |
Christian Medical College Vellore |
Department of Cardiology,
CMC Vellore,
Ranipet Campus,
Vellore
TAMIL NADU |
9940789083
adityabinu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL REVIEW BOARD (IRB), OFFICE OF RESEARCH, CHRISTIAN MEDICAL COLLEGE VELLORE, INDIA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I219||Acute myocardial infarction, unspecified, (2) ICD-10 Condition: I222||Subsequent non-ST elevation (NSTEMI) myocardial infarction, (3) ICD-10 Condition: I229||Subsequent ST elevation (STEMI) myocardial infarction of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional, in-hospital, supervised cardiac
rehabilitation sessions as per institutional CR protocol |
Session will be scheduled 3 times per week for 12 weeks. |
| Intervention |
Structured, app-based cardiac rehabilitation
delivered via interactive telerehabilitation platform (ITRP) including supervised exercise modules, lifestyle counseling, psychosocial
support, and medication adherence reinforcement. |
Sessions will be scheduled 3 times per week
for 12 weeks (total of approximately 36 sessions). |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Adults aged 18-80 years, after obtaining a written informed consent from the participant.
Patients after an event of acute coronary syndrome (ACS) with or without revascularization
(PCI).
Stable CAD with multiple conventional cardiovascular risk factors.
Diffuse CAD or partly revascularized CAD (complete revascularization was not feasible).
Patient with functional class NYHA II-NYHA III (stable)
Patient willing to use Application and should be able to perform Home based Cardiac
Rehabilitation |
|
| ExclusionCriteria |
| Details |
Presence of comorbid diseases or behavioural problems or any other limitations including
dementia/cognitive issues which may interfere with performing unsupervised physical activity
as per HBCR services protocol.
Decompensated heart failure (functional class NYHA IV).
Unstable angina.
Documented history of non-sustained VT, sustained VT or VF without any definitive treatment
(anti- arrhythmic drugs, implantable cardiac- defibrillator, ablation), not rate controlled atrial arrhythmias, mobitz Type II- and third-degree AV blocks.
Documented history of recurrent syncope without definitive diagnosis and/ or presently
undergoing evaluation.
Currently pregnant or intend to become pregnant in next year.
Heart Failure secondary to significant correctable reversible causes like primary valvular
disease or correctable congenital heart disease.
Symptomatic valvular disease (advanced valvular heart disease stage American Heart
Association class C-D).
Severe uncontrolled hypertension (SBP greater than 200 mm hg or DBP greater than 100 mm hg) not on medications (if blood pressures are controlled on mediation will be enrolled for the study). |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Completion of all scheduled rehabilitation sessions |
Six months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Functional capacity (6MWT, treadmill test), quality of life (EQ-5D-5L,
MLHFQ), composite adverse clinical events, echocardiographic and biochemical parameters,
psychological status (PHQ-9), medication adherence (MMAS-8), and tobacco or smoking
cessation. |
Six months |
|
|
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)
|
31/03/2026 |
| 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="2"
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
|
Cardiac rehabilitation (CR) plays a crucial role in managing cardiovascular disease (CVD) in developed nations, but it has not yet gained widespread acceptance in India. In India, CR is significantly underutilized, with only one center available for every 360 cases of ischemic heart disease (IHD), resulting in a CR density of 360 (number of new IHD cases per year per CR spot). Consequently, India ranks among the lowest globally in terms of CR availability and access. The significant gap between the demand for and the availability of CR services suggests that a home-based CR model could address issues like accessibility, transportation costs, and time constraints. No randomized controlled trials have been conducted in India to compare the effectiveness of home-based CR with hospital-based CR. CR programs have been shown to improve functioning and quality of life as well as cardiovascular
morbidity and mortality rates in adults with ischemic heart disease (IHD) following coronary
interventions, heart failure, or cardiac surgery; however, participation in CR programs remains
highly variable worldwide. These are significantly underused in India, with only a minority of
eligible patients participating in CR. Novel delivery strategies and CR endorsement by
healthcare organizations are urgently needed to improve participation rate. One potential strategy
is home based CR (HBCR). Differing from conventional center based CR (CBCR) which are
provided in medical supervised facility, HBCR relies on remote coaching with indirect exercise
supervision. It is provided mostly or entirely outside of the traditional centre-based setting and
could be facilitated by the aid of technology and web based applications. Cochrane
collaborative reviews have compared Centre Based Cardiac Rehabilitation (CBCR) and HBCR
and concluded that there is strong evidence that HBCR and CBCR have similar effects on quality
of life and cost among patients with recent MI or coronary revascularization
We wish to study the efficacy of a home cardiac rehabilitation program via Interactive Tele-Rehabilitation Platform (ITRP) as compared to in- hospital cardiac rehabilitation (IHCR) in adult patients with coronary artery disease. |