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CTRI Number  CTRI/2025/08/093470 [Registered on: 22/08/2025] Trial Registered Prospectively
Last Modified On: 22/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of pulmonary rehabilitation and shoulder exercise on post-CABG patients’ quality of life 
Scientific Title of Study   Effect of pulmonary rehabilitation and shoulder exercise in post CABG patients and QOL 
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 Ambreen Fatima 
Designation  Assistant Professor 
Affiliation  Galgotias University 
Address  Room No.- B228, B Block, Galgotias University, Plot No.2, Sector 17-A Yamuna Expressway, Opposite Buddha International Circuit, Greater Noida

Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  9760084221  
Fax    
Email  ambreen.fatima@galgotiasuniversity.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Gangesh Maheshwari 
Designation  BPT Student 
Affiliation  Galgotias University 
Address  Room No.- B228, B Block, Galgotias University, Plot No.2, Sector 17-A Yamuna Expressway, Opposite Buddha International Circuit, Greater Noida

Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  9520387911  
Fax    
Email  dr.nainamaheshwari@gmail.com  
 
Details of Contact Person
Public Query  
Name  Gangesh Maheshwari 
Designation  BPT Student 
Affiliation  Galgotias University 
Address  Room No.- B228, B Block, Galgotias University, Plot No.2, Sector 17-A Yamuna Expressway, Opposite Buddha International Circuit, Greater Noida

Gautam Buddha Nagar
UTTAR PRADESH
203201
India 
Phone  9520387911  
Fax    
Email  dr.nainamaheshwari@gmail.com  
 
Source of Monetary or Material Support  
galgotias university 
 
Primary Sponsor  
Name  nil 
Address  nil 
Type of Sponsor  Other [nil] 
 
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 
Dr shravan kumar gupta  Galgotias University  Room No- B228, B block, Galgotias University,near yamuna expressway, sector-17A, gautambuddh nagar
Gautam Buddha Nagar
UTTAR PRADESH 		 8115048804

npr9247@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Departmental Research Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I251||Atherosclerotic heart disease of native coronary artery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control Group - Usual Care / Standard Post-CABG Rehabilitation  Type: Routine physiotherapy care. Details: General mobility exercises and cardiovascular endurance training without specific shoulder-focused rehabilitation. 
Intervention  Experimental - Pulmonary Rehabilitation with Structured Shoulder Exercise Program  Pulmonary rehabilitation + structured shoulder exercise program, 3 sessions/week for 4 weeks. ROM exercises (flexion, abduction, external rotation). Strengthening (isometrics, theraband). Scapular stability drills. Breathing techniques (diaphragmatic, pursed-lip, incentive spirometry). Aerobic walking progression.  
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Adults aged 45 to 70 years

CABG done within past 1 to 3 months

Shoulder stiffness or limited mobility post-CABG

Cleared for rehab by cardiologist
 
 
ExclusionCriteria 
Details  Pre-existing shoulder injuries

Unstable cardiac conditions or medical complications

Cognitive impairments 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Shoulder Range of Motion (ROM)-goniometer
Pain – Visual Analog Scale (VAS)
Functional ability – SPADI (Shoulder Pain and Disability Index)

 		 4 weeks (Day 28)
 
 
Secondary Outcome  
Outcome  TimePoints 
Shoulder Range of Motion (Goniometer)
Shoulder Pain and Disability Index (SPADI)
Pain severity (Visual Analog Scale)
Cardiovascular endurance (6-Minute Walk Test)
Pulmonary function (incentive spirometry performance) 		 Baseline and after 6 weeks of intervention. 
 
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   N/A 
Date of First Enrollment (India)   15/09/2025 
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="0"
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  

Coronary Artery Bypass Grafting (CABG) is a common surgical procedure for coronary artery disease. While life-saving, patients frequently experience post-operative complications such as shoulder dysfunction, pain, restricted mobility, and impaired pulmonary function due to sternotomy and prolonged immobility. These factors negatively affect functional recovery and quality of life (QOL).

This randomized controlled trial aims to evaluate the effect of a structured pulmonary rehabilitation and shoulder exercise program on QOL, shoulder mobility, pain reduction, and functional recovery in post-CABG patients. A total of 30 participants, aged 45–70 years and within 1–3 months post-surgery, will be recruited and randomly allocated into two groups. The experimental group will receive pulmonary rehabilitation and a structured shoulder exercise program, while the control group will undergo usual care without targeted shoulder rehabilitation.

The intervention for the experimental group will include breathing exercises (diaphragmatic, pursed-lip breathing, incentive spirometry), progressive range of motion (ROM) exercises, scapular stability training, and light strengthening with resistance bands, performed under physiotherapist supervision for 4 weeks (3 sessions per week).

Outcome measures will include Quality of Life (SF-36/MacNew questionnaire) as the primary outcome, and secondary outcomes such as shoulder ROM (goniometer), pain (Visual Analog Scale), functional ability (Shoulder Pain and Disability Index – SPADI), cardiovascular endurance (6-Minute Walk Test), and pulmonary function. Assessments will be done at baseline and after 6 weeks.

It is hypothesized that pulmonary rehabilitation combined with shoulder-specific exercises will significantly improve QOL, reduce pain, enhance shoulder mobility, and promote faster recovery compared to usual care. Findings from this study are expected to provide evidence for integrating structured physiotherapy protocols into standard post-CABG rehabilitation programs, thereby enhancing patient outcomes and reducing long-term disability.

 
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