| CTRI Number |
CTRI/2025/12/099405 [Registered on: 18/12/2025] Trial Registered Prospectively |
| Last Modified On: |
12/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective study |
| Study Design |
Other |
|
Public Title of Study
|
Early Exercise-Based Rehabilitation for Patients After Heart Attack |
|
Scientific Title of Study
|
Impact of Early Cardiac Rehabilitation on patients with Acute Myocardial Infarction: A Prospective Observational 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 |
Abnip Kaur |
| Designation |
Student |
| Affiliation |
Christian Medical College and Hospital Ludhiana Punjab |
| Address |
Department of Physiotherapy, Ground floor, Christian Medical College and Hospital, Ludhiana, Punjab
Ludhiana
PUNJAB
141008
India |
| Phone |
9814522240 |
| Fax |
|
| Email |
abnipkaur@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandeep Singh Saini |
| Designation |
Professor |
| Affiliation |
Christian Medical College and Hospital Ludhiana Punjab |
| Address |
Department of Physiotherapy, Ground floor, Christian Medical College and Hospital Ludhiana Punjab
Ludhiana
PUNJAB
141008
India |
| Phone |
9463666668 |
| Fax |
|
| Email |
principalcop@cmcludhiana.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Osheen Bhandari |
| Designation |
Assistant Professor |
| Affiliation |
Christian Medical College and Hospital Ludhiana Punjab |
| Address |
Department of Physiotherapy, ground floor, Christian Medical College and Hospital Ludhiana, Punjab
Ludhiana
PUNJAB
141008
India |
| Phone |
8289008397 |
| Fax |
|
| Email |
osheenbhandari1@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Abnip Kaur |
| Address |
Patti Puran, Fazilka, Punjab, India- 152123 |
| Type of Sponsor |
Other [Self paid] |
|
|
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 |
| Abnip Kaur |
Department of Cardiology, Christian Medical College and Hospital, Ludhiana |
Department of physiotherapy, ground floor, Christian Medical College and Hospital, Ludhiana, Punjab, India
Ludhiana
PUNJAB |
9814522240
abnipkaur@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Christian Medical College and Hospital, Ludhiana |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I219||Acute myocardial infarction, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All patients newly diagnosed with Acute Myocardial Infarction aged more than 18 years.
Patients cleared for Cardiac Rehabilitation from the cardiologist within 7 days of their admission. |
|
| ExclusionCriteria |
| Details |
Patients having Severe Respiratory Distress.
Patients on full Inotropic support.
Any musculoskeletal alterations limiting the proposed exercises.
Comorbidities including: Neurological conditions with sensory deficit, Severe cognitive impairment, Active bleeding, Pulmonary Embolism, Severe Anemia and Active infection or Sepsis
Patients in Hypotension i.e. Systolic Blood Pressure less than 90mmHg.
Acute Coronary Syndrome patients on Intra-Aortic Balloon Pump (IABP) support.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The 6 minute wak test, The Barthel Index and The Borg CR-10 Scale |
Measured on the date of discharge from the hospital |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Any symptoms of exercise induced ischemia or complications and the duration of the hospital stay |
Measured on the date of discharge from the hospital |
|
|
Target Sample Size
|
Total Sample Size="133"
Sample Size from India="133"
Final Enrollment numbers achieved (Total)= "133"
Final Enrollment numbers achieved (India)="133" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
29/12/2025 |
| Date of Study Completion (India) |
27/01/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
27/01/2026 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
The effects of using Early Cardiac Rehabilitation in Intensive Coronary Care Units (ICCUs) are unclear for patients being admitted after Acute Myocardial Infarction (AMI). There is scarcity of data on the effects which has inspired the objective of this study to evaluate the effectiveness of Early Cardiac Rehabilitation on patients with Acute Myocardial Infarction. This will be a Prospective Observational Study conducted on patients newly diagnosed with Acute Myocardial Infarction admitted in the Intensive Coronary Care Unit in the Department of Cardiology, Christian Medical College and Hospital, Ludhiana. Patients will be screened and eligible patients would be recruited following the clearance from the Cardiologist. After a complete General Examination and NYHA Functional Classification, a protocol guide based cardiac rehabilitation plan will be implemented within seven days of their admission, monitored by the target heart rate readings calculated by using the Karvonen Formula and RPE readings noted using the Borg CR-10 Scale. Effectiveness would be assessed using the Exercise Testing (The 6-minute walk test), the Barthel Index Scores and Borg CR-10 Scale, noting any changes in the functional status. Additionally any symptoms of exercise induced ischemia and complications with the protocol would be recorded along with the hospital stay duration. A sample size of 133 has been considered for the study based on the prevalence of acute myocardial infarction.
|