| CTRI Number |
CTRI/2024/09/073617 [Registered on: 09/09/2024] Trial Registered Prospectively |
| Last Modified On: |
22/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness of Benson’s Relaxation Technique with Arm Ergometer in Patients after Coronary Artery Bypass Surgery |
|
Scientific Title of Study
|
Effectiveness of Benson’s Relaxation Technique with Arm Ergometer to Improve Lung Efficiency, Pain Intensity and Quality of Life in Patients After Coronary Artery Bypass Grafting |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Barvi Bandral |
| Designation |
MPT Student |
| Affiliation |
Mahatma Gandhi University of Medical Sciences and Technology, Jaipur |
| Address |
Mahatma Gandhi Physiotherapy College, Mahatma Gandhi University of Medical Sciences and Technology, RIICO Institutional Area, Sitapura, Tonk Road, Jaipur
Jaipur RAJASTHAN 302022 India |
| Phone |
6006475305 |
| Fax |
|
| Email |
barvi1975@mgumst.org |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Yuthika Rao |
| Designation |
Associate Professor |
| Affiliation |
Mahatma Gandhi University of Medical Sciences and Technology, Jaipur |
| Address |
Cardiopulmonary Physiotherapy Lab, Mahatma Gandhi Physiotherapy College, Mahatma Gandhi University of Medical Sciences and Technology, RIICO Institutional Area, Sitapura, Tonk Road, Japiur
Jaipur RAJASTHAN 302022 India |
| Phone |
9530096172 |
| Fax |
|
| Email |
physioyuths@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Yuthika Rao |
| Designation |
Associate Professor |
| Affiliation |
Mahatma Gandhi University of Medical Sciences and Technology, Jaipur |
| Address |
Cardiopulmonary Physiotherapy Lab, Mahatma Gandhi Physiotherapy College, Mahatma Gandhi University of Medical Sciences and Technology, RIICO Institutional Area, Sitapura, Tonk Road, Japiur
Jaipur RAJASTHAN 302022 India |
| Phone |
9530096172 |
| Fax |
|
| Email |
physioyuths@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Physiotherapy College, Mahatma Gandhi University of Medical Sciences and Technology, Jaipur |
|
|
Primary Sponsor
|
| Name |
Barvi Bandral |
| Address |
Ward no 1, Near GMS Ramkot, Billawar, Ramkot, Kathua, Jammu and Kashmir |
| 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 Yuthika Rao |
Mahatma Gandhi Physiotherapy College, MGUMST, Jaiipur |
Mahatma Gandhi University of Medical Sciences & Technology, RIICO Institutional Area, Sitapura, Tonk Road, Jaipur, 302022 Jaipur RAJASTHAN |
9530096172
physioyuths@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Mahatma Gandhi Medical College and Hospital, MGUMST, Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I258||Other forms of chronic ischemic heart disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Benson’s Relaxation Technique with Arm Ergometer |
Warm-up exercises: Breathing exercises (Diaphragmatic breathing and pursed lip breathing) followed by gentle movements of upper limb (shoulder shrugs, elbow movements, wrist pumps).
To initiate the arm ergometer post-operative day 1, we will follow the FITT principle for exercise prescription as follows:
Frequency: We will give two sessions per day.
Intensity: The intensity will be low to moderate with no resistance. Monitor heart rate (aim for 40-50% of heart rate reserve) and ensure it stays within the prescribed limits.
Time: We will begin with exercise using arm ergometer as tolerable to the patient.
Type: We will use an arm ergometer for cardiovascular exercise and emphasize controlled and smooth movements to avoid excessive strain. We will include both forward and backward pedalling as well as proper body positioning.
To initiate the Benson Relaxation Response, we will take the following steps:
Take a comfortable seat and sit quietly.
Close your eyes.
Let all of your muscles relax fully.
Inhale via your nose. Pay attention to how you breathe. Say the word "ONE" to yourself in silence as you exhale. Take a breath, for instance, IN—OUT, "ONE": IN—OUT, "ONE": etc. Inhale smoothly and instinctively.
Keep going for ten to twenty minutes. To check the time, you can open your eyes, but avoid setting an alarm. After youre done, take a few minutes to sit quietly, first with your eyes closed and then with them open. Keep down your feet for a few minutes. |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Subjects who underwent CABG in the hospital.
Subjects with ejection fraction ranging from 50% and more.
Subjects that will be medically and clinically stable after surgery will be taken.
Subjects willing to participate in the study.
Subjects able to provide verbal and written consent. |
|
| ExclusionCriteria |
| Details |
Subjects who had developed hemodynamic complications (e.g. lung congestion, subjects on intra-aortic balloon, preoperative myocardial infarction).
Subjects with ejection fraction less than 50%.
Post-operative renal failure.
Post-operative arrhythmia needed for a pacemaker.
Post-operative mechanical ventilation (more than 24 hours).
Previous history of cardiac surgery. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Numeric Pain Rating Scale (NPRS)
Incentive Spirometer
36-Item Short Form Survey (SF-36) |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incentive Spirometer |
2nd day, 5th 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 |
|
Date of First Enrollment (India)
|
30/09/2024 |
| 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
Modification(s)
|
The eligibility of the participants will be taken on the basis of the inclusion criteria of this research study. The informed consent will be taken from 60 subjects that will be selected according to the inclusion criteria. Pre-Operative Procedure:- All the patients who will be involved in the study will be given consent form for their willingness to participate in the study. The demographic data of the patient will be taken pre-operatively. The patients will be instructed and taught about the Bensons relaxation technique that contains all the breathing techniques. The patients will be taught about arm ergometer and its significance. Post-Operative Procedure:- Post-operative program will be started after the patient will be extubated from the mechanical ventilator. The patient must be hemodinamically stable from the first day till the day of discharge from CTVS at least for 7 days after the surgery (post-operatively) The pain levels of the patient will be assessed using Numeric Pain Rating Scale (NPRS) after surgery at day 1 and day 7. The patient’s inspiratory and expiratory capacity will be measured using 3-ball incentive spirometer and quality of life will be assessed using SF-36 questionnaire on day 1 and then on day 7. Treatment Protocol: Warm-up exercises: Breathing exercises (Diaphragmatic breathing and pursed lip breathing) followed by gentle movements of upper limb (shoulder shrugs, elbow movements, wrist pumps). To initiate the arm ergometer post-operative day 1, we will follow the FITT principle for exercise prescription as follows: Frequency: We will give two sessions per day. Intensity: The intensity will be low to moderate with no resistance. Monitor heart rate (aim for 40-50% of heart rate reserve) and ensure it stays within the prescribed limits. Time: We will begin with exercise using arm ergometer as tolerable to the patient. Type: We will use an arm ergometer for cardiovascular exercise and emphasize controlled and smooth movements to avoid excessive strain. We will include both forward and backward pedalling as well as proper body positioning. To initiate the Benson Relaxation Response, we will take the following steps: Take a comfortable seat and sit quietly. Close your eyes. Let all of your muscles relax fully. Inhale via your nose. Pay attention to how you breathe. Say the word "ONE" to yourself in silence as you exhale. Take a breath, for instance, IN and OUT, "ONE": IN and OUT, "ONE": etc. Inhale smoothly and instinctively. Keep going for ten to twenty minutes. To check the time, you can open your eyes, but avoid setting an alarm. After you are done, take a few minutes to sit quietly, first with your eyes closed and then with them open. Keep down your feet for a few minutes. |