| CTRI Number |
CTRI/2024/10/075426 [Registered on: 17/10/2024] Trial Registered Prospectively |
| Last Modified On: |
15/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Buteyko Breathing Technique with
Incentive Spirometry versus Progressive Muscle Relaxation
Technique with Incentive Spirometry on Anxiety and Depression
in Hospitalized Post CABG Patiens |
|
Scientific Title of Study
|
To Compare the Effects of Buteyko Breathing Technique with
Incentive Spirometry versus Progressive Muscle Relaxation
Technique with Incentive Spirometry on Anxiety and Depression
in Hospitalized Post CABG Patients
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rani Kumari |
| Designation |
MPT student |
| Affiliation |
Mahatma Gandhi University of Medical Scineces and Technology |
| Address |
Cardiopulmonary Physiotherapy Lab, Mahatma Gandhi Physiotherapy College, Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
08809378263 |
| Fax |
|
| Email |
rani1972@mgumst.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yuthika Rao |
| Designation |
Associate Professor |
| Affiliation |
Mahatma Gandhi University of Medical Scineces and Technology |
| Address |
Cardiopulmonary Physiotherapy Lab, Mahatma Gandhi Physiotherapy College, Jaipur
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 Scineces and Technology |
| Address |
Cardiopulmonary Physiotherapy Lab, Mahatma Gandhi Physiotherapy College, Jaipur
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, RIICO institutional area, sitapura,tonk raod ,jaipur, Rajasthan(India) , 302022 |
|
|
Primary Sponsor
|
| Name |
Rani Kumari |
| Address |
Near Rajendra College More, Bharati Lodge Lane, Kashi Bazar, Main Road, Chapra, Saran, Bihar - 841301 |
| 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 Hospital Jaipur |
CTVS Department, SRCC Building ,3rd Floor Mahatma Gandhi Hospital ,jaipur
Jaipur
RAJASTHAN |
9530096172
physioyuths@gamil.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 |
Buteyko Breathing Technique |
Control pause (CP)
The patient will be sitting upright in a good posture with relaxed shoulders and rested lower back.
The patient will not change breathing before taking CP. Patient will be asked to take a small breath IN (inspire for two seconds) and a small breath OUT (expire for three seconds). Hold the nose on the “OUT†breath, it will empty lungs but not too empty.
Holding nose is necessary to prevent air entering into the airways. Count how many seconds the patient can comfortably last before there is a need to
breathe in again. Hold your breath until you feel the first need to breathe in. Release the
nose and breathe in through it.
The first intake of breath after the Control Pause will not be greater than breath before
taking measurements; will not hold your breath for too long as this may cause you to take
a big breath after measuring the CP. It will be done 3 times and will take the mean of three trialsSTEP 2- Shallow breathing
To monitor the amount of air flowing through the patient‟s nostrils by placing the
patient‟s finger under the nose in a horizontal position.
Then, breathe air slightly into the tip of the patient‟s nostrils. For example, just take
enough air to fill the nostrils and no more. Breathe in a flicker of air with each breath.
The patient will be asked to exhale to pretend that the patient‟s finger is a feather and to
breathe out gently onto the patient‟s finger so that the feather does not move.
Breathe out and concentrate on calming the patients breath to reduce the amount of warm
air the patient feels on the finger.
As the patient reduces the amount of warm air on the patient finger, the patient will begin
to feel a need or want for air.STEP 3- Putting it together
Take control pause
Reduced breathing for 3 mins.
Incentive spirometry (IS) training will be taught to the patient:-
The patient will be asked to sit and relax quietly for a few mins. and pay attention to their
present breathing. Then the patient will hold the spirometer in one hand and the
mouthpiece in the other hand.
The patient will take three to four slow, easy breaths and maximally exhale with the
fourth breath.
Then, the patient will be asked to place the IS in the patients mouth and maximally inhale
through the spirometer to try to raise the ball in the chamber as high as possible the
patient will then hold the inspiration for 1-2 sec, before exhaling normally. |
| Comparator Agent |
Progressive Muscle Relaxation Technique |
Progressive muscle relaxation technique will be taught to the patient. The progressive muscle relaxation technique will be followed by incentive spirometry.
|
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patient willing to participate
Able to follow command Subjects with ejection fraction ranging from 50% and more |
|
| ExclusionCriteria |
| Details |
Patient with previous neurological conditions
Hemodynamically unstable patient
Patients who are unwilling to participate
Epileptic patient |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Hospital Anxiety and Depression Scale (HADS)
2.Visual Analogue Scale (VAS) |
6 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Visual Analogue Scale (VAS) |
2nd day , 4th 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
|
Phase 3 |
|
Date of First Enrollment (India)
|
04/11/2024 |
| 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
|
Buteyko breathing technique with incentive spiromerty will be performed on 20 subjects.The buteyko breathing will be tought to the patient-
STEP 1- control phases STEP 2- Shallow breathing STEP 3- Putting it together
Incentive spirometry training will be tought- 1. the patients will hold the spirometry on one hand and the mouthpiece in the other hand. 2. the patients will take to four slow , easy breaths and maximally exhale with fourth breath 3.then, the patents will be asked to place the IS in the patients mouth and maximally inhale through the spirometry to try to raise the ball in the chamber as high as possible the patient will then hold the inspiration for 1-2 sec ,before exhaling normally.
Progressive Muscle Relaxation with incentive spirometry will be performed 20 subjects. - progressive muscle relaxation Techinque will be tought to the patients .the progressive muscle relaxation technique will be followed by incentive spirometry.
|