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Clinical Trials/CTRI/2025/07/090231
CTRI/2025/07/090231
Not yet recruiting
Not Applicable

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

Dr Heena Jain1 site in 1 country30 target enrollmentStarted: July 25, 2025Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Dr Heena Jain
Enrollment
30
Locations
1
Primary Endpoint
Volume oriented spirometer for pulmonary capacity specifically tidal volume (TV), inspiratory reserve volume (IRV) and

Overview

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.

  1. 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.

Study Design

Study Type
Interventional
Allocation
Na
Masking
Outcome Assessor Blinded

Eligibility Criteria

Ages
30.00 Year(s) to 55.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Volume oriented spirometer for pulmonary capacity specifically tidal volume (TV), inspiratory reserve volume (IRV) and

Time Frame: 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.

inspiratory capacity (IC).

Time Frame: 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.

Functional Difficulties questionnare (FDQ) for Daily life functional tasks.

Time Frame: 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 Outcomes

No secondary outcomes reported

Investigators

Sponsor
Dr Heena Jain
Sponsor Class
Private medical college
Responsible Party
Principal Investigator
Principal Investigator

Dr Heena Jain

Mahatma Gandhi College Of Physiotherapy, MGUMST , Jaipur

Study Sites (1)

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