| CTRI Number |
CTRI/2026/01/101495 [Registered on: 19/01/2026] Trial Registered Prospectively |
| Last Modified On: |
17/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effect of Simple Positioning and Exercise on Breathing and Movement in Patients After Coronary Angioplasty. |
|
Scientific Title of Study
|
Combined Efficacy of Lateral Positioning and Core Stability Exercises on Cardio-Respiratory Function and Mobility in Patients underwent Coronary Angioplasty– A quasi experimental 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 |
Archit Shetty |
| Designation |
post graduate physiotherapy student |
| Affiliation |
Institute of physiotherapy |
| Address |
Department of cardiovascular and respiratory science institute of physiotherapy srinivas university dakshina kannada mangalore
Dakshina Kannada KARNATAKA 575001 India |
| Phone |
6363198260 |
| Fax |
|
| Email |
archit09shetty@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr M Premkumar |
| Designation |
Professor |
| Affiliation |
Institute of physiotherapy |
| Address |
Department of cardiovascular and respiratory science institute of physiotherapy srinivas university dakshina kannada mangalore
Dakshina Kannada KARNATAKA 575001 India |
| Phone |
9442508754 |
| Fax |
|
| Email |
premkumar.ipt@srinivasuniversity.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Archit Shetty |
| Designation |
Professor |
| Affiliation |
Institute of physiotherapy |
| Address |
Department of cardiovascular and respiratory science institute of physiotherapy srinivas university dakshina kannada mangalore
Dakshina Kannada KARNATAKA 575001 India |
| Phone |
6363198260 |
| Fax |
|
| Email |
archit09shetty@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Archit Shetty |
| Address |
Institute of physiotherapy srinivas university pandeshwar mangalore 575001 |
| 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 Archit Shetty |
Srinivas Institute of medical science and research centre |
cardiac ICU department, ground floor, Srinivas institute of medical science and health research, mukka, suratkal, manguluru Dakshina Kannada KARNATAKA |
6363198260
archit09shetty@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL REVIEW BOARD AND ETHICAL COMMITTEE (IRBEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I208||Other forms of angina pectoris, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
core stability exercises
lateral positioning |
Core stability exercises in sitting position will be given daily during the patient’s ICU stay, approximately 48–72 hours. |
| Comparator Agent |
normal conservative exercises
|
Patients will receive Phase I cardiac rehabilitation from the first post-procedure day until discharge from the ICU approximately 2–3 days |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
NYHA classification I, II, III
Patients undergone angioplasty
Patients having stable vitals
Patient having GCS level greater than or equal to 13 |
|
| ExclusionCriteria |
| Details |
Pacemaker implantation
Amputation
Heart Failure
Haemodynamic instability at rest
Prolonged pyrexia |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| ICU mobility scale |
Baseline
3rd day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 2 min walk test |
baseline
3rd day |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
02/02/2026 |
| 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 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
|
This is a quasi-experimental clinical study evaluating the combined effect of lateral positioning and core-stability exercises during Phase-I cardiac rehabilitation in post-coronary angioplasty patients. Thirty-six patients (35–60 years, NYHA I–III, stable vitals) will be recruited and allocated into two groups using purposive sampling at Srinivas Institue of medical science. The intervention group will receive lateral positioning plus core-stability exercises as part of Phase-I rehabilitation, while the control group will receive conventional Phase-I cardiac rehabilitation. The primary outcomes are mobility and functional exercise tolerance, measured using the ICU Mobility Scale and Talk Test. The study aims to determine whether this combined intervention leads to faster recovery, improved functional capacity, and reduced ICU-acquired weakness and hospital stay compared with standard care. The findings are expected to support evidence-based Phase-I rehabilitation protocols for post-angioplasty patients in routine cardiac care. |