| CTRI Number |
CTRI/2025/07/090231 [Registered on: 04/07/2025] Trial Registered Prospectively |
| Last Modified On: |
03/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Breath Stacking Technique on Pulmonary Capacity and Daily Life functional Tasks after Mitral Valve Replacement surgery |
|
Scientific Title of Study
|
Evaluating the impact of Breath Stacking Technique on Enhancing Pulmonary Capacity
and Daily Life Functional Tasks in the Early Post Operative Phase of Mitral Valve Replacement Surgery 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 |
Dr Heena Jain |
| Designation |
MPT Student |
| Affiliation |
Mahatma Gandhi College Of Physiotherapy, MGUMST , Jaipur |
| Address |
Cardiopulmonary Lab, Mahatma Gandhi College of Physiotherapy, Mahatma Gandhi University of Medical Science and Technology, RIICO Industrial Area, RIICO Institutional Area, Sitapura
Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
7740977276 |
| Fax |
|
| Email |
heena@mgumst.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yuthika Rao |
| Designation |
Associate Professor |
| Affiliation |
Mahatma Gandhi College of Physiotherapy, MGUMST, Jaipur |
| Address |
Cardiopulmonary Lab, Mahatma Gandhi College of Physiotherapy, Mahatma Gandhi University of Medical Science and Technology, RIICO Industrial Area, RIICO Institutional Area, Sitapura
Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
9530096172 |
| Fax |
|
| Email |
dryuthikarao@mgumst.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yuthika Rao |
| Designation |
Associate Professor |
| Affiliation |
Mahatma Gandhi College of Physiotherapy, MGUMST, Jaipur |
| Address |
Cardiopulmonary Lab, Mahatma Gandhi College of Physiotherapy, Mahatma Gandhi University of Medical Science and Technology, RIICO Industrial Area, RIICO Institutional Area, Sitapura
Jaipur
Jaipur
RAJASTHAN
302022
India |
| Phone |
9530096172 |
| Fax |
|
| Email |
dryuthikarao@mgumst.org |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi College Of Physiotherapy, MGUMST, Mahatma Gandhi Road, RIICO Industrial Area, RIICO Institutional Area, Sitapura, Ramchandpura , Jaipur |
|
|
Primary Sponsor
|
| Name |
Dr Heena Jain |
| Address |
Cardiopulmonary Physiotherapy Lab, Mahatma Gandhi Physiotherapy College, Mahatma Gandhi University of Medical Sciences and Technology, Jaipur |
| Type of Sponsor |
Private medical college |
|
|
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 Heena Jain |
Mahatma Gandhi Hospital , Jaipur |
Cardiopulmonary Lab, Department of Physiotherapy , Mahatma Gandhi College of Physiotherapy, MGUMST, RIICO Institutional Area, Sitapura, Jaipur, Ramchandpura, Rajasthan 302022
Jaipur
RAJASTHAN
Jaipur
RAJASTHAN |
7740977276
heena@mgumst.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Mahatma Gandhi College and Hospital, MGUMST,Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I059||Rheumatic mitral valve disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Breath Stacking Technique |
Patient will be positioned in a lying or long sitting position on the bed with continuous monitoring of hemodynamic parameters.
1. Before initiating the breath stacking technique, deep breathing exercise will be taught to patient, steps will be :
Close your eyes
Close your eyes to help focus on your attention on your breathing. Breathe in slowly through your nose
Take a slow, deep breath in through your nose , focus on filling your lungs completely, allowing your abdomen to rise as you breath in , count to 4 as you inhale. Exhale slowly through your mouth
Exhale slowly through your mouth letting the air out gently. Make a “whoosing” sound if you like. Count to 6 or 8 as you exhale. Repeat the process
Repeat the breathing cycle for about 5 to 10 breaths per minute . Aim for focusing on deep relaxed breathing. 2. To initiate the Breath Stacking Technique, we will take the following steps :-
Patient Position : Long sitting and comfortable position with relaxed shoulder , head and neck .
Breath stack : Instruct patient to take a deep breath and 3-4 breath one over another till the fullness of chest experienced.
Breath holding : Ask patient to hold the breath for a maximum 10 seconds.
Expiration : and then expire by pursed lip breathing.
Pause : There will be a gap of 15-30 seconds in each repetitions to allow relaxations.
Repeat the process : 10 repetition of breath stacking technique |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Subjects who underwent mitral valve replacement surgery, in the hospital.
Only mechanical valve, specifically those used in mitral valve replacement surgery , will be
included .
Age will be ranging from 30 – 55 years old subjects of both sex.
Baseline pulmonary function (TV,IRV,IC) within interpretable limits as per American Thoracic
Society Guidelines.
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.
Patients with reduced pulmonary function post surgery.
Subject must not have been on a ventilator for longer than 24 hour.
Patients should be conscious and oriented. |
|
| ExclusionCriteria |
| Details |
Subjects who had develop hemodynamic complications (e.g. lung congestion , subjects on intra-
aortic balloon, pre-operative myocardial infarction).
Patients with cognitive impairment, reduced cardiac output, recent stroke, respiratory failure
Subjects who undergone major cardiac, pulmonary or abdominal surgery in the last three month.
Patients with physical limitations preventing assessment/exercises.
Patient with history of pulmonary disease or infection such as chronic obstructive pulmonary
disease (COPD) or tuberculosis (TB).
Patients with uncontrolled hypertension.
Patient with neurological / musculoskeletal disorders that could affect the functional capacity or
pulmonary function such as parkinsonism, ankylosing spondylitis, scoliosis etc. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Volume oriented spirometer for pulmonary capacity specifically tidal volume (TV), inspiratory reserve volume (IRV) and
inspiratory capacity (IC).
Functional Difficulties questionnare (FDQ) for Daily life functional tasks. |
Pulmonary capacity specifically tidal volume (TV), inspiratory reserve volume (IRV) and
inspiratory capacity (IC) will be measured by volume oriented spirometer from POD 1 to POD 7
Daily Life Functional Tasks will be measured by Functional Difficulties questionnare (FDQ) on POD 1 and POD 7. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
25/07/2025 |
| 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="1"
Months="0"
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 eligibility of the candidate will be taken on the basis of inclusion criteria . 30 patients will be taken which has undergone mitral valve replacement surgery. Breath Stacking Technique will be applied to see the impact on these outcome measures.
Outcome Measures Pulmonary capacity- specifically tidal volume (TV), inspiratory reserve volume(IRV) and inspiratory capacity(IC) by volume oriented spirometer . Functional difficulties questionnaire (FD-Q) for Daily Life Functional Tasks Treatment Plan Patient will be positioned in a lying / long sitting position on the bed with continuous monitoring of hemodynamic parameters. 1. Before initiating the breath stacking technique, deep breathing exercise will be taught to patient, steps will be : Close your eyes : Close your eyes to help focus on your attention on your breathing. Breathe in slowly through your nose : Take a slow, deep breath in through your nose , focus on filling your lungs completely, allowing your abdomen to rise as you breath in , count to 4 as you inhale. Exhale slowly through your mouth : Exhale slowly through your mouth letting the air out gently. Make a “whooshing” sound if you like. Count to 6 or 8 as you exhale. Repeat the process : Repeat the breathing cycle for about 5 to10 breaths per minute . Aim for focusing on deep relaxed breathing.
2. To initiate the Breath Stacking Technique, we will take the following steps :- Patient Position : Long sitting and comfortable position with relaxed shoulder , head and neck . Breath stack : Instruct patient to take a deep breath and 3-4 breath one over another till the fullness of chest experienced. Breath holding : Ask patient to hold the breath for a maximum 10 seconds. Expiration : and then expire by pursed lip breathing. Pause : There will be a gap of 15-30 seconds in each repetitions to allow relaxations. Repeat the process : 10 repetition of breath stacking technique. |