| 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
|
|
|
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
|
|
|
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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