| CTRI Number |
CTRI/2025/07/090952 [Registered on: 15/07/2025] Trial Registered Prospectively |
| Last Modified On: |
02/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to understand the benefit of a hybrid cardiac rehabilitation program using a mobile app for heart patients |
|
Scientific Title of Study
|
Real-World Evaluation of a Hybrid Cardiac Rehabilitation Program Using the LYFE® Platform in Patients with Cardiac Illness: A Post-Marketing Observational Study” |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ali Irani |
| Designation |
HOD- Department of sports medicine and physoptherapy |
| Affiliation |
Nanavati max superspeciality hospital |
| Address |
Ground floor, Department of sports medicine and physiotherapy, Nanavati max super specialty hospital S V road Vile parle west Mumbai
Mumbai (Suburban)
MAHARASHTRA
400056
India |
| Phone |
02226172329 |
| Fax |
|
| Email |
ali.irani@nanavatihospital.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ali Irani |
| Designation |
HOD- Department of sports medicine and physoptherapy |
| Affiliation |
Nanavati max superspeciality hospital |
| Address |
Ground floor, Department of sports medicine and physioptherapy,Nanavati max super specialty hospital S V road Vile parle west Mumbai
Mumbai (Suburban)
MAHARASHTRA
400056
India |
| Phone |
02226172329 |
| Fax |
|
| Email |
ali.irani@nanavatihospital.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ali Irani |
| Designation |
HOD- Deapartment of sports medicine and physoptherapy |
| Affiliation |
Nanavati max superspeciality hospital |
| Address |
Ground floor, Department of sports medicine and physioptherapy,Nanavati max super specialty hospital S V road Vile parle west Mumbai
Mumbai (Suburban)
MAHARASHTRA
400056
India |
| Phone |
02226172329 |
| Fax |
|
| Email |
ali.irani@nanavatihospital.org |
|
|
Source of Monetary or Material Support
|
| Lupin Digital health, 3 rd floor , vinay bhavya complex,sanatacruz east, Mumbai 400098, India |
|
|
Primary Sponsor
|
| Name |
Dr Ayesha Shaikh |
| Address |
3 rd floor Vinay Bhavya complex Kalina Santacruz east Mumbai |
| 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 poonam |
Nanavati superspeciality hospital |
Nanavati superspeciality hospital, Department of physiotherapy, vile parle west Mumbai 400056, india
Mumbai (Suburban)
MAHARASHTRA |
9821820233
poonam.parulekar@nmims.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitonalethicscommittee |
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 |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Eligible for CR per guidelines
2. Confirmed diagnosis of any cardiac conditions
3. Willing an able to provide consent
4.Has a smartphone with reliable internet connection |
|
| ExclusionCriteria |
| Details |
1.Severe comorbidities contraindicating CR
2.MSK, Neurological or psychiatric condition impeding participation
3. Inability to perform 6MWT /comply with follow ups as per study
4.Unwillingness to provide consent
5. A part of another study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To asses the utilization of hybrid CR in patients with cardiac illness
2.To evaluate the effectiveness of Hybris rehab compared to in center CR program |
1. Baseline
2. 85th day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To measure the improvement in functional capacity- 6MWT
2.To asses the QOL - SF 36 questionnaire
3. to provide evidence supporting the intergation of hybrid CR |
1. Baseline
2. 85TH day |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
15/07/2025 |
| 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="0"
Months="3"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response (Others) - NONE
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) - To be decided
- For how long will this data be available start date provided 31-12-2025 and end date provided 30-06-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
To summarize the potential impact of hybrid cardiac rehabilitation on overall patient adoption.
To provide evidence to support the integration of hybrid cardiac rehabilitation programs as compared to only in-center programs.
To optimize care pathways and rehabilitation strategies for cardiac patients
To assess the improvement in functional capacity (6MWT).
To assess the improvement in Quality of Life (QoL) 
|