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CTRI Number  CTRI/2025/07/091028 [Registered on: 16/07/2025] Trial Registered Prospectively
Last Modified On: 16/07/2025
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   Physiotherapy for faster recovery after Heart Surgery 
Scientific Title of Study   Effect of Physiotherapeutic Clavipectoral and Sternoclavicular Fascia Release on Cardiopulmonary Parameters Post Cardiac valve replacement Surgery A Randomized Clinical 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  Aishwarya Aishwarya 
Designation  MPT Student 
Affiliation  Delhi Pharmaceutical Sciences and Research University 
Address  Room no 605, 6th floor, School of Physiotherapy, Delhi Pharmaceutical Sciences and Research University (DPSRU), Pushp Vihar, Sector 3, New Delhi - 110017, India

South
DELHI
110017
India 
Phone  9319754504  
Fax    
Email  draishwaryapt@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Richa Hirendra Rai 
Designation  Professor 
Affiliation  Delhi Pharmaceutical Sciences and Research University 
Address  Room no 605, 6th floor, School of Physiotherapy, Delhi Pharmaceutical Sciences and Research University (DPSRU), Pushp Vihar, Sector 3, New Delhi - 110017, India

South
DELHI
110017
India 
Phone  9350267077  
Fax    
Email  richarai@dpsru.edu.in  
 
Details of Contact Person
Public Query
 
Name  AishwaryaAishwarya 
Designation  MPT student 
Affiliation  Delhi Pharmaceutical Sciences and Research University 
Address  Room no 605, 6th floor, School of Physiotherapy, Delhi Pharmaceutical Sciences and Research University (DPSRU), Pushp Vihar, Sector 3, New Delhi - 110017, India

South
DELHI
110017
India 
Phone  9319754504  
Fax    
Email  draishwaryapt@gmail.com  
 
Source of Monetary or Material Support  
Ground floor, DPSRU OPD(Delhi Pharmaceutical Sciences and Research University) 
 
Primary Sponsor  
Name  Delhi Pharmaceutical Sciences and Research University 
Address  Room no 605, 6th floor, New building, School of Physiotherapy, Delhi Pharmaceutical Sciences and Research University (DPSRU), Pushp Vihar, Sector 3, New Delhi - 110017, India 
Type of Sponsor  Research institution 
 
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 Sheetal Kalra  Ground floor, DPSRU Physiotherapy OPD  Room no 605, 6th floor, New building, School of Physiotherapy, Delhi Pharmaceutical Sciences and Research University (DPSRU), Pushp Vihar, Sector 3, New Delhi - 110017, India
South
DELHI 
9990003410

sheetalkalra@dpsru.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I089||Rheumatic multiple valve disease,unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control Group  This group will receive conventional cardiac rehabilitation starting from postoperative day 1 to day 10, once daily for 15–20 minutes. The intervention will continue for a total of 10 days. 
Intervention  Fascia release Technique  The process will include conventional cardiac rehabilitation for the first 5 postoperative days. From postoperative day 6 to day 10, fascial release technique will be added once daily for 15–20 minutes, comprising 10 strokes per session per fascia release, along with continued conventional rehab. 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  patients aged 40–65 years, medically stable and referred by a cardiac surgeon, of either sex (male or female), undergoing elective surgical cases for cardiac rehabilitation with stable vitals, uncomplicated cases of surgery referred by a cardiothoracic surgeon, classified as NYHA class 1 to 3, with LVEF greater than 30%, and subjects who understand the Hindi language and are willing to participate. 
 
ExclusionCriteria 
Details  Unstable angina pectoris, uncontrolled arrhythmias, intermittent mandatory ventilation (IMV) on or after the 0th day, any life-threatening co-morbidities, any locomotor, neurological, or systemic disorder, use of medications apart from valve replacement surgical treatment that can affect the outcome of the study, and a history of prior cardiac surgery, stroke, or pulmonary diseases that can affect the outcome of the study.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Respiratory Rate in breaths/min,
SPO2 (oxygen saturation) in %,
Chest expansion in centimeters,
Heart rate in beats/min,
Blood pressure in mm hg.
 
Baseline (before intervention) preoperatively
Post operatively on 5th day
Post operatively on 10th day 
 
Secondary Outcome  
Outcome  TimePoints 
CVA (Craniovertebral angle) in degrees
Balance score by berg balance scale
PEFR(peak expiratory flow rate)
Functional capacity by 6MWD in metres
Psychological score by DASS-21 (depression anxiety stress scale)
Pain by Visual Analogue Scale (VAS) score
 
Baseline (before intervention) preoperatively
Post operatively on 5th day
Post operatively on 10th day 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   01/08/2025 
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="4"
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  

The study titled "Effect of Physiotherapeutic Clavipectoral and Sternoclavicular Fascia Release on Cardiopulmonary Parameters in Post Cardiac Valve Replacement Surgery: A Randomized Clinical Trial" will be conducted to assess the impact of fascial release techniques on cardiopulmonary and other functional outcomes in patients undergoing cardiac valve replacement surgery. Subjects will be selected based on defined inclusion and exclusion criteria. Patients aged between 40 to 80 years, of either sex, who will undergo uncomplicated elective cardiac surgery and are medically stable, will be included. Those with unstable angina, uncontrolled heart rhythm abnormalities, serious coexisting illnesses, or a prior history of cardiac or lung disease will be excluded. All participants will provide informed consent after receiving a detailed explanation of the procedure.

A total of 64 patients will initially be assessed, with some expected to be excluded or refuse participation. The remaining subjects will be randomly allocated into two groups. Group A will receive conventional cardiac rehabilitation, while Group B will receive additional physiotherapeutic intervention involving clavipectoral and sternoclavicular fascial release. The study will follow a randomized controlled trial design, and subjects will be selected using convenience sampling followed by random allocation. Data will be collected at three different time points: preoperatively on day zero, and postoperatively on day five and day ten. Variables to be measured will include respiratory parameters such as respiratory rate, oxygen saturation, chest expansion at various thoracic levels, and peak expiratory flow rate; cardiac functions like heart rate and blood pressure; and other outcomes such as craniovertebral angle, balance, functional capacity, pain, and psychological parameters including depression, anxiety, and stress. The study will be carried out over a four-month period at a reputed hospital in Delhi and aims to determine whether fascial release techniques provide additional benefits over standard rehabilitation alone.


 
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