| CTRI Number |
CTRI/2024/04/065148 [Registered on: 03/04/2024] Trial Registered Prospectively |
| Last Modified On: |
22/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Randomized Controlled Trial to Assess And Compare The Effect Of A Combined Intervention Involving Cardiac Rehabilitation And Meditation Versus Cardiac Rehabilitation Alone In Coronary Artery Bypass Grafting (Cabg) Patient On Functional Capacity And Mental Health Component Using SF-36 |
|
Scientific Title of Study
|
Assess And Compare The Effect Of A Combined Intervention Involving Cardiac Rehabilitation And Meditation Versus Cardiac Rehabilitation Alone In Coronary Artery Bypass Grafting (CABG) Patient On Functional Capacity And Mental Health Component Using SF-36: 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 |
Dr Mohini Gadge |
| Designation |
PG Student |
| Affiliation |
Datta Meghe Institute of Higher Education and Research (Deemed to be University), Sawangi(Meghe) |
| Address |
Department of Cardiorespiratory Physiotherapy Ravi Nair Physiotherapy College Datta Meghe Institute of Higher Education and Research (Deemed to be University), Sawangi(Meghe) Wardha MAHARASHTRA 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
7774058838 |
| Fax |
|
| Email |
mohinigadge7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Lajwanti Lalwani |
| Designation |
Associate professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research (Deemed to be University), Sawangi(Meghe) |
| Address |
Department of Cardiorespiratory Physiotherapy Ravi Nair Physiotherapy College Datta Meghe Institute of Higher Education and Research (Deemed to be University) Sawangi(Meghe) Wardha MAHARASHTRA 442001
Department of Cardiorespiratory Physiotherapy Ravi Nair Physiotherapy College Datta Meghe Institute of Higher Education and Research (Deemed to be University) Sawangi(Meghe) Wardha MAHARASHTRA 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
8605234269 |
| Fax |
|
| Email |
drlalwanilajwanti@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Lajwanti Lalwani |
| Designation |
Associate professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research (Deemed to be University), Sawangi(Meghe) |
| Address |
Department of Cardiorespiratory Physiotherapy Ravi Nair Physiotherapy College Datta Meghe Institute of Higher Education and Research (Deemed to be University) Sawangi(Meghe) Wardha MAHARASHTRA 442001
Department of Cardiorespiratory Physiotherapy Ravi Nair Physiotherapy College Datta Meghe Institute of Higher Education and Research (Deemed to be University) Sawangi(Meghe) Wardha MAHARASHTRA 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
8605234269 |
| Fax |
|
| Email |
drlalwanilajwanti@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ravi Nair Physiotherapy College Cardiovascular Thoracic Surgery ICU in AVBRH, Sawangi (Meghe) wardha India |
|
|
Primary Sponsor
|
| Name |
Ravi Nair Physiotherapy College |
| Address |
Department of Cardiorespiratory Physiotherapy Ravi Nair Physiotherapy College Datta Meghe Institute of Higher Education and Research (Deemed to be University), Sawangi(Meghe) |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Mohini Sunil Gadge |
Acharya Vinoba Bhave Rural Hospital And Cvts Icu And Cvts Ward |
Department of Cardiorespiratory Physiotherapy Ravi Nair Physiotherapy College Datta Meghe Institute of Higher Education and Research (Deemed to be University), Sawangi(Meghe)
Wardha
MAHARASHTRA |
7774058838
mohinigadge7@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: I255||Ischemic cardiomyopathy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Cardiac Rehabilitation |
This group will receive Cardiac Rehabilitation |
| Intervention |
Cardiac Rehabilitation with Meditation |
This group will receive Cardiac Rehabilitation along with Meditation |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients are clinically diagnosed with Coronary arteries blockage. Operated for CABG referred to physiotherapy.
2. Age group of 35-65 years.
3. Patient who will sign the consent form.
4. Both Male and Female patient.
5. Patient with ability to understand and follow instructions.
|
|
| ExclusionCriteria |
| Details |
1. Unstable angina
2. Rib Fracture
3. Patient with neurological conditions
4. Hemodynamically unstable.
|
|
|
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 |
1. 6 Minute walk test
2. SF-36 |
Outcome will be assessed at baseline and after 2 week. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. DASS-21
2. HADS |
Outcome will be assessed at baseline & after 2 week. |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
12/04/2024 |
| 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="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
|
The aim of the study is to assess and to
compare the effect of Cardiac rehabilitation and meditation (combine) against
cardiac rehabilitation alone on functional capacity and mental health using SF-36 Scale CABG patients.
|