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CTRI Number  CTRI/2024/04/065502 [Registered on: 10/04/2024] Trial Registered Prospectively
Last Modified On: 09/04/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Single Arm Study 
Public Title of Study   Understanding How Repeat 6MWT Practice Impacts Walking Ability in CABG Patients 
Scientific Title of Study   Learning Effect of 6-Minute Walk Test on Walking Distance During Phase I Rehabilitation in Patient with CABG: 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  Rishabh Shah 
Designation  Undergraduate Student  
Affiliation  MGM Institute of Physiotherapy 
Address  Department of Cardiovascular and respiratory Physiotherapy, MGM Institute of Physiotherapy, Chhatrapati Sambhaji Nagar
12, Amizarna AApartment, Tilakwadi, Sharanpur road
Nashik
MAHARASHTRA
431003
India 
Phone  8149173711  
Fax    
Email  shahrishabh332@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Manish P Shukla 
Designation  Associate Professor 
Affiliation  MGM Institute of Physiotherapy 
Address  Department of Cardiovascular and respiratory Physiotherapy, MGM Institute of Physiotherapy, Chhatrapati Sambhaji Nagar
Jai Serenity Apartment, Gadiya Vihar Road, Shahnoorwadi, Chhatrapati Sambhaji Nagar
Aurangabad
MAHARASHTRA
431003
India 
Phone  9960290614  
Fax    
Email  manish.shukla20@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Rishabh Shah 
Designation  Undergraduate Student  
Affiliation  MGM Institute of Physiotherapy 
Address  MGM INSTITUTE OF PHYSIOTHERAPY Department of Cardiovascular and respiratory Physiotherapy, MGM Institute of Physiotherapy, Chhatrapati Sambhaji Nagar
12, Amizarna AApartment, Tilakwadi, Sharanpur road
Nashik
MAHARASHTRA
431003
India 
Phone  8149173711  
Fax    
Email  shahrishabh332@gmail.com  
 
Source of Monetary or Material Support  
MGM medical College, Chhatrapati Sambhaji Nagar, Maharashtra, India 
 
Primary Sponsor  
Name  MGM Institute of Physiotherapy  
Address  N6,Cidco,Aurangabad, 431003  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Rishabh Amit Shah  MGM Medical College, Chhatrapati Sambhaji Nagar  Male Medicine Ward, Ward Number 360. MGM Hospital, N-6 Cidco, Chhatrapati Sambhaji Nagar
Aurangabad
MAHARASHTRA 
08149173711

shahrishabh332@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committe, MGM Institute of Physiotherapy, Aurangabad  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I240||Acute coronary thrombosis not resulting in myocardial infarction,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Learning effect of 6 Minute Walk test   6 Minute walk test is used for study where repeatability of the test is done so as to see whether there occurs increase in the walking distance as the patients gets to know the test by which it helps in incraesing the physical capacity o the patient after discharge from the hospital thus helping in Activity of Daily Life(ADLs) . So it helps to prove that the by doing successive test the walking distance increases due to the learning effect. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients undergone CABG Surgery within Phase I of Rehabilitation  
 
ExclusionCriteria 
Details  Unstable Angina, MI , Resting heart rate >120 beats/min , Blood pressure >180mm/hg
(systolic) >100mm/hg(diastolic), Respiratory Distress , Osteoarthritis, Rheumatoid Arthritis, Severe Hypoxemia , Acute Respiratory Failure 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Walking Distance measurement
Saturation of oxygen
Rate of perceived Exersion 
Before 6 Minute walk test and Immediately after 6 Minute walk test. 
 
Secondary Outcome  
Outcome  TimePoints 
Heart Rate, Respiratory Rate  Before 6 Minute walk test & Immediately after 6 Minute walk test. 
 
Target Sample Size   Total Sample Size="54"
Sample Size from India="54" 
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)   20/04/2024 
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 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 bypass grafting (CABG) is a major surgical operation where atheromatous 
blockages in a patient’s coronary arteries are bypassed with harvested venous or arterial 
conduits. In general, on-pump and off-pump are the 2 types of CABG surgical procedures 
with the difference being the use of a cardiopulmonary bypass circuit and an arrested heart to 
operate during an on-pump CABG. The World Health Organization has reported coronary 
artery disease the major cause of death in developing countries. It accounts about 13.7% of 
total number of deaths. Current burden of coronary artery disease in India stands >32 million 
patients. Unhealthy lifestyle is associated with risk factor for chronic disease such as 
Hypertension, Diabetes Mellitus and Obesity which is in turn major risk factor of coronary 
artery disease.
CABG was first performed in India in 1975 about 13 years after its advent in 1962. The 
annual number of Coronary Artery Bypass Grafting Surgeries carried out in India stands out 
at 60,000. Exercise capacity and quality of life are the main outcomes in cardiac 
rehabilitation (CR). Exercise capacity is one of the important prognostic and diagnostic 
measures acquired by ETT that is an estimate of VO2max, measured in units of metabolic 
equivalents (MET) . One MET is the amount of oxygen consumption required in a resting 
state, and equals 3.5 ml of oxygen per kilogram of body weight per minute for an average 
adult .
The 6-min walking test (6MWT) is a simple test, which does not require expensive 
equipment or advanced training. It has been used in heart failure patients to assess exercise 
tolerance, the effects of therapy and prognosis.
2 The 6-min walk test (6MWT), as a functional 
walking test, is another tool for assessing exercise capacity that nowadays with the growing 
attention to functional and inexpensive outcome measures in therapeutic interventions, and 
for its ease of performance, has become a more applicable approach. The primary outcome 
in the 6MWT is the 6-min walk distance (6MWD), which can be used for exercise 
prescription and is also suitable for pre- and post-CR outcome assessment . Maintaining 
adequate physical endurance in later year is important to prevent Frailty and loss of 
independence, Considering the typical decline of aerobic power (Vo2 peak) of approximately 
5 ml kg/min per decade. Many inactive older adults will reach or surpass the threshold 
required for independent living by their 70s or 80s unless steps are taken to reduce the rate of 
decline
 
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