| CTRI Number |
CTRI/2025/07/091574 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
23/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study to Assess the Impact of Outpatient Cardiac Rehabilitation on Exercise Tolerance and Quality of Life in Patients Undergoing Coronary Artery Bypass Grafting
|
|
Scientific Title of Study
|
The effect of cardiac rehabilitation on exercise tolerance and quality of life in patients with coronary artery bypass grafting (Coronary Artery Bypass Grafting) in outpatient phase |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rupam Sarkar |
| Designation |
Assistant Professor |
| Affiliation |
Maharashtra University of Health Sciences, Nashik, Maharashtra 422004 |
| Address |
Sri Aurobindo Super Specialty Hospital and Physiotherapy Department Indore, Madhya Pradesh
Nashik
MAHARASHTRA
453555
India |
| Phone |
9564736713 |
| Fax |
|
| Email |
dr.rupamsarkarpt@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Rajni Pawar |
| Designation |
Professor |
| Affiliation |
Sri Aurobindo Institute of Allied Health Paramedical Sciences Indore,Madhya Pradesh 453555 |
| Address |
Sri Aurobindo Super Specialty Hospital and Physiotherapy Department Indore, Madhya Pradesh
Nashik
MAHARASHTRA
453555
India |
| Phone |
09752048737 |
| Fax |
|
| Email |
rajnispawar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rupam Sarkar |
| Designation |
Assistant Professor |
| Affiliation |
Maharashtra University of Health Sciences, Nashik, Maharashtra 422004 |
| Address |
Sri Aurobindo Super Specialty Hospital and Physiotherapy Department Indore, Madhya Pradesh
Nashik
MAHARASHTRA
453555
India |
| Phone |
09564736713 |
| Fax |
|
| Email |
dr.rupamsarkarpt@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Aurobindo Institute of Allied Health Paramedical SciencesIndore-Ujjain,state Highway,near MR10 Road, Indore, Madhya Pradesh 453555 |
|
|
Primary Sponsor
|
| Name |
Rupam Sarkar |
| Address |
Maharashtra University of Health Sciences, Vani- Dindori Rd,Mhasrul Gaon, Nashik, Maharashtra 422004 |
| Type of Sponsor |
Other [[Self]] |
|
|
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 RUPAM SARKAR |
Sri Aurobindo Institute of Allied Health Paramedical Sciences Indore, Madhya Pradesh |
Physiotherapy OPD Room no.22, Sri Aurobindo Super specialty Hospital and Physiotherapy Department Indore, Madhya Pradesh
Nashik
MAHARASHTRA |
09564736713
dr.rupamsarkarpt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Indore, Madhya Pradesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: I278||Other specified pulmonary heart diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cardiac Rehabilitation |
Weeks 1–2: Aerobic Conditioning and Flexibility
Patients perform light aerobic activities and stretching to restore mobility and circulation. Sessions last 30 minutes, 5 days a week, maintaining a target heart rate of 55–70% of maximum.
Stretching includes neck, shoulder, triceps, forearm, quadriceps, and calf muscles (10 repetitions, held for 10–15 seconds each).
Active movements such as elbow extensions, arm raises, waist bends, trunk twists, and marching in place (5–20 repetitions) are used to enhance functional mobility.
Aerobic exercises include 5 minutes each of walking/treadmill and cycling, plus climbing 2 flights of stairs.
---
Weeks 3–4: Strength and Endurance
Exercise duration is increased to 45 minutes per session, still 5 days a week. Strength training begins using 0.5 kg weights for upper limb exercises (biceps curls, arm raises, triceps extensions) and 1 kg for lower limb exercises (knee extensions, leg raises, hamstring curls).
Repetitions are kept between 10–20 per set.
Aerobic endurance is enhanced with 10 minutes each of walking/treadmill and cycling, along with climbing 3–4 flights of stairs.
---
Weeks 5–6: Strength Progression and Cardiovascular Advancement
Sessions last 60 minutes, 5 times per week, maintaining the same target heart rate. Strength load is increased to 1 kg for upper limbs and 1.5–2 kg for lower limbs, keeping the repetition range between 10–20.
Aerobic training is advanced to 15 minutes each of walking/treadmill and cycling, along with climbing 4 or more flights of stairs.
The focus is on improving cardiovascular fitness and strength, with close monitoring for fatigue or overexertion. |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Post CABG Patient entering in outpatient phase
Both Genders
Cooperative subjects |
|
| ExclusionCriteria |
| Details |
Severe Cardiac disorders
Non-Cooperative patients
Differently abled patients
Any other systemic disorders |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
6 Minutes walk test and SF-12 Patients Questionnaire
|
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 2 |
|
Date of First Enrollment (India)
|
03/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
03/08/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="22"
Months="8"
Days="30" |
|
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
|
CABG is most common type of heart surgery. Cardiac Rehabilitation following CABG surgery aims to minimise post- operative pulmonary complications. Quality of life (QOL) and exercises tolerance are important factor in the prognosis of CABG as well as evaluate effects of different interventions in cardiovascular diseases. 30 sample of both male and female between age 50-80 years who fulfil inclusion criteria were selected randomly for this study. All subject were under gone Pre and Post 6MWT $ evaluated with Pre and Post QOL SF-12 Patient Questionnaire to evaluate the effect of CR Post CABG on exercises tolerance and QOL. The data was evaluated by statistical analysis which showed there is a significant improvement in exercises tolerance as well as QOL in Patient with CABG after applying cardiac rehabilitation exercises. |