| CTRI Number |
CTRI/2024/12/078832 [Registered on: 31/12/2024] Trial Registered Prospectively |
| Last Modified On: |
30/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of modified and Standard Cardiac Rehabilitation program on Bio- Psycho-physiological Parameters among Acute Coronary Syndrome patients |
|
Scientific Title of Study
|
Effect of modified Cardiac Rehabilitation and Standard Cardiac Rehabilitation program on Bio- Psycho-physiological Parameters among Acute Coronary Syndrome patients at tertiary care institute: 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 |
Mr Maneesh Sharma |
| Designation |
Assitant Professor |
| Affiliation |
AIIMS, Rishikesh, Uttarakhand |
| Address |
Building no 45, Level II, Faculty room 1, College of Nurisng, AIIMS, Rishikesh
Building no 45, Level II, Faculty room 1, College of Nurisng, AIIMS, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9001689135 |
| Fax |
|
| Email |
manishsharma740@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Rakesh Sharma |
| Designation |
Assitant Professor |
| Affiliation |
AIIMS, Rishikesh, Uttarakhand |
| Address |
Building no 45, Level II, Faculty room II, College of Nurisng, AIIMS, Rishikesh
Building no 45, Level II, Faculty room II, College of Nurisng, AIIMS, Rishikesh
Dehradun
UTTARANCHAL
249202
India |
| Phone |
9639553333 |
| Fax |
|
| Email |
rakesh553333@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Maneesh Sharma |
| Designation |
Assitant Professor |
| Affiliation |
AIIMS, Rishikesh, Uttarakhand |
| Address |
Building no 45, Level II, Faculty room 1, College of Nurisng, AIIMS, Rishikesh
Building no 45, Level II, Faculty room 1, College of Nurisng, AIIMS, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9001689135 |
| Fax |
|
| Email |
manishsharma740@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hospital block, 255 B, Deparartment of CTVS, Level V, AIIMS, Rishikesh, Uttarakhand, India
Pin 249203 |
|
|
Primary Sponsor
|
| Name |
Mr Maneesh Sharma Self funded |
| Address |
Building no 45, Level II, Faculty room 1, College of Nurisng, AIIMS, Rishikesh |
| Type of Sponsor |
Other [Self funded ] |
|
|
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 Maneesh Sharma |
All India Institute of Medical Sciences |
Room no 3, Hospital block, 255 B, Deparartment of CTVS, Level V, AIIMS, Rishikesh, Uttarakhand, India Pin 249203
Dehradun
UTTARANCHAL |
9001689135
Manishsharma740@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I00-I99||Diseases of the circulatory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Modifed cardiac rehabilitation program |
Number of participants allocated to the experimental group will undergo modified cardiac rehabilitation program at the time of discharge, at 4-6 weeks & 10-12 weeks of follow-up. Also a information booklet will be given to follow instructions and log book to record daily adherence to MCRP program. The total duration of intervention will be of 8-10 weeks i.e 2 to 2 & half months for a single participant. |
| Comparator Agent |
Standard cardiac rehabiltation program |
Participants will undergo standard cardiac rehabiltation program at dicharge, 4-6 and 10-12 weeks.The total duration will be of 8-10 weeks i.e 2 to 2 & half months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria for study participants : Between 18-70 yrs Age .
Able to read, write & understand Hindi and or English language.
Able to perform the exercise & willing to attend rehabilitation programme.
|
|
| ExclusionCriteria |
| Details |
Diagnosed as a case of STMI
History of mental illness
Pregnant patients
Ejection fraction less than 40
Having any physical disability interfere in rehabilitation process such as vision or hearing defect, neurological, musculoskeletal conditions
Refuse to participate and not signing the consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary out come will be 6 min walk test which will be assessed at discharge, 4-6 and 8-10 weeks of follow up. |
At dischage, 4-6 weeks and 10-12 weeks of follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Biological variables : Lipid profile & HbA1c
Physiological variables : Heart rate, blood pressure
Physical variables : Weight, BMI, Waist circumference
Psychological variables : Anxiety & Depression, quality of life
Other variable : Mortality |
At dischage, 4-6 weeks and 10-12 weeks of follow up |
|
|
Target Sample Size
|
Total Sample Size="154"
Sample Size from India="154"
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)
|
16/01/2025 |
| 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="2"
Months="6"
Days="15" |
|
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
|
Coronary artery disease is the most common cause of death from cardiovascular disease, which is the leading cause of mortality world wide. India has high burden of cardiovascular disease result in high cost incurred to patients, with many of them being unable to afford even the basic preventive medications. Thus there is need for cost effective measures for controlling CVD. Evidences from different parts of the world indicates that structured approaches to secondary prevention such as cardiac rehabilitation (CR) have health favoring impacts on quality of life (QOL), morbidity, and mortality. The purpose of present study to assess the impact of modified CR program i.e CR + breathing exercises (documented in literature but not practiced) on bio-physio-psychological parameters. |