| CTRI Number |
CTRI/2025/04/084272 [Registered on: 07/04/2025] Trial Registered Prospectively |
| Last Modified On: |
06/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [CARDIAC REHABILITATION] |
| Study Design |
Other |
|
Public Title of Study
|
what are the effects of rehabilitation in health of patients recovered from an acute episode of heart attack. |
|
Scientific Title of Study
|
Effect Of Early Cardiac Rehabilitation On Functional Capacity In Patients With Acute Myocardial Infarction. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sruthi Ravi |
| Designation |
PG Resident |
| Affiliation |
VMMC & Safdharjung Hospital, Indraprastha university, Delhi Medical Council |
| Address |
PMR Department
VMMC & Safdharjung Hospital
New Delhi
H5/10
Malaviya Nagar
Near Hitesh Mehta Park
New Delhi
South
DELHI
110029
India |
| Phone |
8590247431 |
| Fax |
|
| Email |
sruthiravi96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Suman Badhal |
| Designation |
consultant |
| Affiliation |
VMMC & Safdharjung Hospital |
| Address |
PMR Department
VMMC & Safdharjung Hospital
New Delhi
South
DELHI
110029
India |
| Phone |
9958289313 |
| Fax |
|
| Email |
drsuman_badhal@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Sruthi Ravi |
| Designation |
PG Resident |
| Affiliation |
VMMC & Safdharjung Hospital |
| Address |
PMR DEPARTMENT
VMMC & Safdharjung Hospital
New Delhi
South
DELHI
110029
India |
| Phone |
8590247431 |
| Fax |
|
| Email |
sruthiravi96@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NOT APPLICABLE |
| Address |
NOT APPLICABLE |
| Type of Sponsor |
Other [NOT APPLICABLE] |
|
|
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 Sruthi Ravi |
Department of Cardiology, VMMC & Safdharjung Hospital , New Delhi |
Room number- 351
Cardiology Department
super speciality block
VMMC & Safdharjung Hospital
New Delhi
South
DELHI |
8590247431
sruthiravi96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I21A||Other type of myocardial infarction, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
cardiac rehabilitation |
cardiac rehabilitation exercises will be given to patients according to phases as intervention and its effects will be studied in further follow ups using tests and questionnaires. |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Clinically and hemodynamically stable post acute myocardial infarction patients of age group between 18-65 years. |
|
| ExclusionCriteria |
| Details |
clinically and hemodynamically unstable patients and musculoskeletal conditions that prevent adequate participation in exercise. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to assess the effect of early cardiac rehabilitation on functional capacity |
functional capacity assessed at time of baseline, 4th week and 6th week post discharge. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to assess the effect of early cardiac rehabilitation on quality of life, left ventricular ejection fraction & body mass index |
assessed at time of baseline & at 6th week post discharge |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
06/05/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Early Cardiac rehabilitation will be given for patients who were diagnosed with acute myocardial infarction who underwent revascularization and are hemodynamically stable and will be assessed for effects of early cardiac rehabilitation on functional capacity, left ventricular ejection fraction, quality of life and body mass index during phase 1 cardiac rehabilitation then after phase 2 cardiac rehabilitation and finally after 6 weeks during phase 3 cardiac rehabilitation. |