<?xml version="1.0" encoding="UTF-8"?><!DOCTYPE article PUBLIC "-//NLM//DTD JATS (Z39.96) Journal Publishing DTD v1.2 20190208//EN" "http://jats.nlm.nih.gov/publishing/1.2/JATS-journalpublishing1.dtd"><article xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" article-type="other" dtd-version="1.2" xml:lang="en">
    <front>
        <journal-meta>
            <journal-id journal-id-type="pmc">F1000Research</journal-id>
            <journal-title-group>
                <journal-title>F1000Research</journal-title>
            </journal-title-group>
            <issn pub-type="epub">2046-1402</issn>
            <publisher>
                <publisher-name>F1000 Research Limited</publisher-name>
                <publisher-loc>London, UK</publisher-loc>
            </publisher>
        </journal-meta>
        <article-meta>
            <article-id pub-id-type="doi">10.12688/f1000research.144783.1</article-id>
            <article-categories>
                <subj-group subj-group-type="heading">
                    <subject>Study Protocol</subject>
                </subj-group>
                <subj-group>
                    <subject>Articles</subject>
                </subj-group>
            </article-categories>
            <title-group>
                <article-title>Efficacy of POWERbreathe Medic Plus device on maximal inspiratory pressure, functional capacity and quality of life in coronary artery bypass graft patients: A randomized controlled trial protocol</article-title>
                <fn-group content-type="pub-status">
                    <fn>
                        <p>[version 1; peer review: awaiting peer review]</p>
                    </fn>
                </fn-group>
            </title-group>
            <contrib-group>
                <contrib contrib-type="author" corresp="no">
                    <name>
                        <surname>Vardhan</surname>
                        <given-names>Vishnu</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Conceptualization</role>
                    <role content-type="http://credit.niso.org/">Investigation</role>
                    <role content-type="http://credit.niso.org/">Methodology</role>
                    <role content-type="http://credit.niso.org/">Supervision</role>
                    <role content-type="http://credit.niso.org/">Validation</role>
                    <role content-type="http://credit.niso.org/">Visualization</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Original Draft Preparation</role>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Review &amp; Editing</role>
                    <xref ref-type="aff" rid="a1">1</xref>
                </contrib>
                <contrib contrib-type="author" corresp="yes">
                    <name>
                        <surname>Nikhade</surname>
                        <given-names>Dhanashri N.</given-names>
                    </name>
                    <role content-type="http://credit.niso.org/">Writing &#x2013; Review &amp; Editing</role>
                    <uri content-type="orcid">https://orcid.org/0009-0001-3746-3418</uri>
                    <xref ref-type="corresp" rid="c1">a</xref>
                    <xref ref-type="aff" rid="a1">1</xref>
                </contrib>
                <aff id="a1">
                    <label>1</label>Cardiorespiratory Physiotherapy Department,, Ravi nair physiotherapy college, datta meghe institute of higher education and research, Wardha, Maharashtra, 442001, India</aff>
            </contrib-group>
            <author-notes>
                <corresp id="c1">
                    <label>a</label>
                    <email xlink:href="mailto:dhanashrin001@gmail.com">dhanashrin001@gmail.com</email>
                </corresp>
                <fn fn-type="conflict">
                    <p>No competing interests were disclosed.</p>
                </fn>
            </author-notes>
            <pub-date pub-type="epub">
                <day>10</day>
                <month>5</month>
                <year>2024</year>
            </pub-date>
            <pub-date pub-type="collection">
                <year>2024</year>
            </pub-date>
            <volume>13</volume>
            <elocation-id>472</elocation-id>
            <history>
                <date date-type="accepted">
                    <day>2</day>
                    <month>5</month>
                    <year>2024</year>
                </date>
            </history>
            <permissions>
                <copyright-statement>Copyright: &#x00a9; 2024 Vardhan V and Nikhade DN</copyright-statement>
                <copyright-year>2024</copyright-year>
                <license xlink:href="https://creativecommons.org/licenses/by/4.0/">
                    <license-p>This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.</license-p>
                </license>
            </permissions>
            <self-uri content-type="pdf" xlink:href="https://f1000research.com/articles/13-472/pdf"/>
            <abstract>
                <p>Coronary artery disease (CAD) is a prominent cause of illness and mortality worldwide, with a significant amount of coronary artery bypass graft (CABG) surgeries performed each year. It is a complicated technique that results in several clinical and functional issues. While CABG is an effective treatment, it comes with clinical and functional challenges, including reduced lung volume, maximal inspiratory and expiratory pressure, and thoracic mobility after surgery. Incisional pain has been associated with a decline in postoperative lung function; however, this resolves a month following surgery. There is no documented association between respiratory muscle strength and lung function after heart surgery. The POWERbreathe Medic Plus is intended for patients who have extremely weak breathing muscles as a result of illness, hospitalization, or existing respiratory health disorders such as Chronic Obstructive Pulmonary Disease (COPD) and asthma. To address these challenges, a study will investigate the efficacy of the POWERbreathe Medic Plus device in improving maximal inspiratory pressure, functional capacity, and quality of life in CABG patients.</p>
                <p>CTRI no. &#x2013; CTRI/2023/04/052116</p>
                <p>Link-
                    <uri xlink:href="https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=ODMxNTA=&amp;Enc=&amp;userName=CTRI/2023/04/052116">https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=ODMxNTA=&amp;Enc=&amp;userName=CTRI/2023/04/052116</uri>
                </p>
                <p>CTRI registration date &#x2013; 28/04/2023</p>
            </abstract>
            <kwd-group kwd-group-type="author">
                <kwd>Powerbreathe medic plus Device</kwd>
                <kwd>Coronary Artery Bypass Graft</kwd>
                <kwd>quality of life</kwd>
                <kwd>maximal inspiratory pressure</kwd>
                <kwd>functional capacity.</kwd>
            </kwd-group>
            <funding-group>
                <funding-statement>The author(s) declared that no grants were involved in supporting this work.</funding-statement>
            </funding-group>
        </article-meta>
    </front>
    <body>
        <sec id="sec1" sec-type="intro">
            <title>Introduction</title>
            <p>Coronary artery disease is a major reason for illness and fatality worldwide. In India, every year, around 1,40,000 CABG (Coronary Artery Bypass Graft) surgeries are carried out. It is a revascularization method that involves redirecting blood flow to other arteries to enhance blood supply to the heart muscles.
                <sup>
                    <xref ref-type="bibr" rid="ref1">1</xref>
                </sup> Despite significant breakthroughs in clinical care and interventional treatments, CABG is the most widely utilized type of cardiac surgery performed globally, and an excellent therapy for reducing symptoms and mortality in individuals with coronary artery disease (CAD).
                <sup>
                    <xref ref-type="bibr" rid="ref2">2</xref>
                </sup>
                <sup>,</sup>
                <sup>
                    <xref ref-type="bibr" rid="ref3">3</xref>
                </sup> CABG, on the other hand, is a challenging procedure that causes a host of clinical and functional issues.
                <sup>
                    <xref ref-type="bibr" rid="ref4">4</xref>
                </sup> Some degree of pulmonary impairment is unavoidable in the immediate postoperative period following CABG.
                <sup>
                    <xref ref-type="bibr" rid="ref5">5</xref>
                </sup> These effects may persist, resulting in 25-30% reductions in lung volume,
                <sup>
                    <xref ref-type="bibr" rid="ref6">6</xref>
                </sup> maximal inspiratory and expiratory pressure (MIP and MEP) relative to expected values),
                <sup>
                    <xref ref-type="bibr" rid="ref7">7</xref>
                </sup> and thoracic mobility.
                <sup>
                    <xref ref-type="bibr" rid="ref8">8</xref>
                </sup>
            </p>
            <p>The patient has a sternotomy and is then connected to a cardiorespiratory bypass machine during coronary artery bypass grafting (CABG), the usual treatment for CAD.
                <sup>
                    <xref ref-type="bibr" rid="ref9">9</xref>
                </sup> However, this form of surgery has a variety of postoperative complications. Two of the most prevalent symptoms are inactivity and pulmonary impairment.
                <sup>
                    <xref ref-type="bibr" rid="ref10">10</xref>
                </sup> These concerns may be connected with socioeconomic costs such as prolonged hospital stays, substantial treatment expenditures, ICU care for the majority of patients, or even fatality if the patient is not effectively managed.
                <sup>
                    <xref ref-type="bibr" rid="ref11">11</xref>
                </sup> General anesthesia, mechanical ventilation duration, cardiopulmonary bypass, and the sternotomy incision can all have an impact on postoperative pulmonary function following heart surgery.
                <sup>
                    <xref ref-type="bibr" rid="ref12">12</xref>
                </sup> The use of cardiopulmonary bypass and general anesthesia in cardiac surgery is a crucial factor in patient outcomes.
                <sup>
                    <xref ref-type="bibr" rid="ref13">13</xref>
                </sup> PPCs have been connected to various cardiopulmonary bypass-related events, including blood exposure to artificial materials, body temperature fluctuation, organ ischemia-reperfusion, surgical trauma, and endotoxin release; all of these generate an immediate inflammatory response.
                <sup>
                    <xref ref-type="bibr" rid="ref14">14</xref>
                </sup>
                <sup>&#x2013;</sup>
                <sup>
                    <xref ref-type="bibr" rid="ref16">16</xref>
                </sup>
            </p>
            <p>Anesthesia may increase the alveolar-arterial oxygen gradient and decrease functional residual capacity and vital capacity, leading to hypoxemia and atelectasis. Anesthetic medications predispose to PPCs by producing immunological dysfunction, which leads to lung damage. Incisional discomfort has been linked to a decrease in postoperative lung function; however, this resolves within a month of surgery.
                <sup>
                    <xref ref-type="bibr" rid="ref17">17</xref>
                </sup>
            </p>
            <p>The POWERbreathe Medic Plus has the lowest initial load of any Plus device, 9 cm H
                <sub>2</sub>O. This gadget is used for low-load respiratory muscle training. The Powerbreathe Medic Plus is intended for those who have very weak breathing muscles as a result of, for example, illness, hospitalization, or existing respiratory health disorders such as COPD and asthma.</p>
            <p>
                <bold>Aim:</bold> To study the efficacy of POWERbreathe Medic Plus device on maximal inspiratory pressure, functional capacity, and quality of life in Coronary Artery Bypass Graft Patients.</p>
        </sec>
        <sec id="sec2">
            <title>Objectives</title>
            <sec id="sec3">
                <title>Primary objectives</title>
                <p>1) To assess the strength of diaphragm by measuring maximum inspiratory pressure (PImax) in Coronary Artery Bypass Graft Patients by a Power Breathe Medic Plus Device.</p>
            </sec>
            <sec id="sec4">
                <title>Secondary objectives</title>
                <p>
                    <list list-type="order">
                        <list-item>
                            <label>1)</label>
                            <p>To assess functional capacity by measuring the Six-minute walk distance.</p>
                        </list-item>
                        <list-item>
                            <label>2)</label>
                            <p>To assess quality of life using SF-36 questionnaire.</p>
                        </list-item>
                        <list-item>
                            <label>3)</label>
                            <p>Duration of hospital stay.</p>
                        </list-item>
                    </list>
                </p>
                <p>
                    <bold>Trial design</bold>
                </p>
                <p>The study will be a single-center, parallel-group, open-label, randomized controlled trial.</p>
            </sec>
        </sec>
        <sec id="sec5">
            <title>Protocol</title>
            <p>Study approval from the Ethics Committee of the Datta Meghe Institute of Higher Education and Research, study participants will be selected from the Cardiovascular and Thoracic Surgery Unit of Acharya Vinoba Bhave Rural Hospital, Sawangi (Meghe), Wardha, Maharashtra, based on inclusion and exclusion criteria. Subjects will be contacted and chosen according to the study&#x2019;s criteria. The sequentially numbered opaque sealed envelope (SNOSE) technique will be employed in a randomised strategy to assign members. This research protocol will examine the impact of the POWERbreathe Medic Plus device on peak inspiratory pressure, functional capacity, and quality of life in transplant patients through an independent two-group study. coronary bypass surgery. There will be 72 individuals in the trial (36 in each traditional group).</p>
            <sec id="sec6">
                <title>Eligibility criteria</title>
                <p>
                    <bold>
                        <italic toggle="yes">Inclusion criteria</italic>
                    </bold>
                    <list list-type="order">
                        <list-item>
                            <label>1.</label>
                            <p>Patients who will sign the written informed consent form.</p>
                        </list-item>
                        <list-item>
                            <label>2.</label>
                            <p>Both male and female patients.</p>
                        </list-item>
                        <list-item>
                            <label>3.</label>
                            <p>Patients who have undergone a coronary artery bypass graft with an age range of 40-70 years.</p>
                        </list-item>
                    </list>
                </p>
                <p>
                    <bold>
                        <italic toggle="yes">Exclusion criteria</italic>
                    </bold>
                    <list list-type="order">
                        <list-item>
                            <label>1.</label>
                            <p>Patients who had developed hemodynamic complications (e.g., preoperative Myocardial Infarction, Lung Congestion, Post-operative renal failure, patients on Intra-aortic balloon pump or arrhythmia needed for a pacemaker).</p>
                        </list-item>
                        <list-item>
                            <label>2.</label>
                            <p>CABG patient on postoperative mechanical ventilation (more than 24 hours).</p>
                        </list-item>
                        <list-item>
                            <label>3.</label>
                            <p>No previous neurological complications in the last 6 months.</p>
                        </list-item>
                        <list-item>
                            <label>4.</label>
                            <p>Unstable angina.</p>
                        </list-item>
                    </list>
                </p>
            </sec>
            <sec id="sec7">
                <title>Interventions</title>
                <p>
                    <bold>
                        <italic toggle="yes">Experimental group</italic>
                    </bold>
                </p>
                <p>The strength of inspiratory muscles will be assessed by a maximal inspiratory pressure device (PImax) device. POWERbreathe Medic plus the device will be given. The patient will be made to sit in a comfortable position with back supported, shoulders relaxed and handle grip of the device in the hand. The mouthpiece will be placed fully into the mouth so that the outer shield will be between lips and gums and a nose clip will be placed on the nose to close both nostrils. Once comfortable, the patient will be asked to take normal-sized, relaxed breaths in and out through the device and will start with the lowest resistance setting and gradually progress to a high 30% of the current PImax. After POWERbreathe Medic Plus device, conventional chest physiotherapy exercises are provided twice a day for two weeks. Two weeks later, participants will be reassessed using the same outcome measures of conditioning effects of the intervention.</p>
                <p>
                    <bold>
                        <italic toggle="yes">Control group</italic>
                    </bold>
                </p>
                <p>Conventional Chest Physiotherapy exercises will be given in the form of Diaphragmatic breathing exercises, Thoracic expansion exercises, and Incentive spirometry. Exercises are provided twice a day for two weeks. Two weeks later, participants will be reassessed using the same outcome measures of conditioning effects of the intervention.</p>
            </sec>
            <sec id="sec8">
                <title>Outcomes</title>
                <p>
                    <bold>
                        <italic toggle="yes">Primary outcome</italic>
                    </bold>
                </p>
                <p>
                    <underline>Change in Maximal Inspiratory Pressure (PImax)</underline>
                </p>
                <p>Micro-RPM calculates the strength of respiratory muscle by calculating the respiratory pressure exerted by patients. To force all breathing to occur through the mouth, the patient must sit in a comfortable position and fasten the nose clip to the nose. The patient must make a tight seal with their lips around the mouthpiece. They must breathe in more deeply than usual, but not all the way, and exhale gently while maintaining an inhalation-to-exhalation ratio of 1:1 or 1:2 (exhale for a lengthier period than they inhale).</p>
                <p>
                    <bold>
                        <italic toggle="yes">Secondary outcome</italic>
                    </bold>
                </p>
                <p>
                    <underline>To change the six-minute walk distance</underline>
                </p>
                <p>Functional capacity is determined by a six-minute walk distance. The 6MWD is a simple and inexpensive submaximal exercise test that the patient tolerates well. It is a field test that is used to measure functional capacity after exercise in persons who have a range of cardiac and pulmonary issues.
                    <sup>
                        <xref ref-type="bibr" rid="ref18">18</xref>
                    </sup>
                </p>
                <p>
                    <underline>Change in quality of life</underline>
                </p>
                <p>The SF-36 surveys,
                    <sup>
                        <xref ref-type="bibr" rid="ref19">19</xref>
                    </sup> which assess quality of life, has 36 sections (questions) that examine physical, psychological, and social functioning. In health research, the SF-36 is the most used quality of life questionnaire. With 36 items encompassing eight areas (social functioning (SF), general health (GH), vitality (VT), physical functioning (PF), physical role functioning (RP), physical pain (BP), and physical functioning (PF), it is a multidimensional questionnaire including both emotional role functioning and mental wellness. The combined findings of the first four areas and the last four areas are a physical health assessment (PCS) and a mental health assessment (MCS), respectively.
                    <sup>
                        <xref ref-type="bibr" rid="ref19">19</xref>
                    </sup>
                </p>
                <p>
                    <underline>Changes in duration of hospital stay</underline>
                </p>
                <p>The length of stay is calculated from the date of admission and date of discharge.</p>
            </sec>
        </sec>
        <sec id="sec9" sec-type="methods">
            <title>Method</title>
            <p>Study Design: Randomised control trial.</p>
            <p>Study Setting: This study will be carried out in Cardiovascular and Thoracic Surgery Unit, Acharya Vinoba Bhave Rural Hospital, Sawangi (Meghe), Wardha, Maharashtra.</p>
            <p>Targeted population: CABG patients from age group of 30-60 years.</p>
            <p>Sampling technique: Simple Random Sampling Technique.</p>
            <p>Allocation
                <bold>:</bold> Sequentially numbered opaque sealed envelope (SNOSE) technique</p>
            <p>Sample size calculation.</p>
            <p>Formula Using Mean difference
                <disp-formula id="e1">
                    <mml:math display="block">
                        <mml:mi mathvariant="normal">n</mml:mi>
                        <mml:mn>1</mml:mn>
                        <mml:mo>=</mml:mo>
                        <mml:mi mathvariant="normal">n</mml:mi>
                        <mml:mn>2</mml:mn>
                        <mml:mo>=</mml:mo>
                        <mml:mn>2</mml:mn>
                        <mml:mfrac>
                            <mml:mrow>
                                <mml:msup>
                                    <mml:mrow>
                                        <mml:mo stretchy="true">(</mml:mo>
                                        <mml:msub>
                                            <mml:mi mathvariant="normal">Z</mml:mi>
                                            <mml:mi mathvariant="normal">&#x03b1;</mml:mi>
                                        </mml:msub>
                                        <mml:mo>+</mml:mo>
                                        <mml:msub>
                                            <mml:mi mathvariant="normal">Z</mml:mi>
                                            <mml:mi mathvariant="normal">&#x03b2;</mml:mi>
                                        </mml:msub>
                                        <mml:mo stretchy="true">)</mml:mo>
                                    </mml:mrow>
                                    <mml:mn>2</mml:mn>
                                </mml:msup>
                                <mml:msup>
                                    <mml:mi mathvariant="normal">&#x03c3;</mml:mi>
                                    <mml:mn>2</mml:mn>
                                </mml:msup>
                            </mml:mrow>
                            <mml:msup>
                                <mml:mrow>
                                    <mml:mo stretchy="true">(</mml:mo>
                                    <mml:mi mathvariant="normal">&#x03b4;</mml:mi>
                                    <mml:mo stretchy="true">)</mml:mo>
                                </mml:mrow>
                                <mml:mn>2</mml:mn>
                            </mml:msup>
                        </mml:mfrac>
                    </mml:math>
                </disp-formula>
            </p>
            <p>Z
                <sub>&#x03b1;</sub> = 1.96</p>
            <p>&#x03b1; = Type l error at 5% at both sides two tailed</p>
            <p>Z
                <sub>&#x03b2;</sub> = 1.645 Power at 95%.</p>
            <p>Difference (Mean) result in 6MWT for conventional chest therapy = 125 (As per ref. article).</p>
            <p>Considering Std. Dev = 145.8</p>
            <p>According to reference articles.
                <disp-formula id="e2">
                    <mml:math display="block">
                        <mml:mtext>N1</mml:mtext>
                        <mml:mo>=</mml:mo>
                        <mml:mn>2</mml:mn>
                        <mml:mo>&#x2217;</mml:mo>
                        <mml:mrow>
                            <mml:mo stretchy="true">[</mml:mo>
                            <mml:msup>
                                <mml:mrow>
                                    <mml:mo stretchy="true">(</mml:mo>
                                    <mml:mn>1.96</mml:mn>
                                    <mml:mo>+</mml:mo>
                                    <mml:mn>1.645</mml:mn>
                                    <mml:mo stretchy="true">)</mml:mo>
                                </mml:mrow>
                                <mml:mn>2</mml:mn>
                            </mml:msup>
                            <mml:msup>
                                <mml:mrow>
                                    <mml:mo stretchy="true">(</mml:mo>
                                    <mml:mn>1.96</mml:mn>
                                    <mml:mo stretchy="true">)</mml:mo>
                                </mml:mrow>
                                <mml:mn>2</mml:mn>
                            </mml:msup>
                            <mml:mo stretchy="true">]</mml:mo>
                        </mml:mrow>
                        <mml:mo>/</mml:mo>
                        <mml:msup>
                            <mml:mrow>
                                <mml:mo stretchy="true">(</mml:mo>
                                <mml:mn>1.65</mml:mn>
                                <mml:mo stretchy="true">)</mml:mo>
                            </mml:mrow>
                            <mml:mn>2</mml:mn>
                        </mml:msup>
                        <mml:mo>=</mml:mo>
                        <mml:mn>32</mml:mn>
                    </mml:math>
                </disp-formula>
            </p>
            <p>Total samples required = 36 per Group.</p>
            <p>Considering 10% drop out = 4</p>
            <p>The total sample size = 72</p>
            <p>Ref Article: - Moderate-to-high intensity inspiratory muscle training improves the effects of combined training on exercise capacity in patients after coronary artery bypass graft surgery: A randomized clinical trial.
                <sup>
                    <xref ref-type="bibr" rid="ref20">20</xref>
                </sup>
            </p>
            <p>
                <bold>Study duration:</bold> The study duration will be one year. The flowchart of consort diagram is shown in 
                <xref ref-type="fig" rid="f1">Figure 1</xref>.</p>
            <fig fig-type="figure" id="f1" orientation="portrait" position="float">
                <label>Figure 1. </label>
                <caption>
                    <title>Flowchart of consort diagram.</title>
                </caption>
                <graphic id="gr1" orientation="portrait" position="float" xlink:href="https://f1000research-files.f1000.com/manuscripts/158628/45e80e48-15da-4782-8f7c-dfe9881e0ff9_figure1.gif"/>
            </fig>
            <sec id="sec10">
                <title>Statistical analysis</title>
                <p>
                    <ext-link ext-link-type="uri" xlink:href="https://posit.co/downloads/">RStudio</ext-link> software version 4.3 will be used to determine the final result. Descriptive statistics (age, BMI) will be produced based on a quantitative examination of the variables` mean, standard deviation, maximum, minimum, and median. For the qualitative assessment, frequency and percentage will be calculated across the variables (lifestyle, gender, and comorbidities). Every inferential statistical result will be generated and analyzed for significance at the 5% level, represented by P = less than 0.05. The outcome variable (MicroRPM for PImax measurement) will be the primary variable, and the supplementary variables (6MWT, SF-36, and length of hospital stay) will be compared between pre- and post-results using paired-t tests. The Kolmogorov-Smirnov test is first performed to determine the normality of the outcome variable data. Information that deviates from common sense.</p>
            </sec>
            <sec id="sec11">
                <title>Dissemination</title>
                <p>The authors are planning to present the research article at a conference.</p>
            </sec>
            <sec id="sec12">
                <title>Study status</title>
                <p>The study is yet to be started.</p>
            </sec>
            <sec id="sec13">
                <title>Ethical considerations</title>
                <p>This study was approved by Datta Meghe Institute of Higher Education on 21 March 2023 (DMIHER (DU)/IEC/2023/545).</p>
                <p>Written informed consent will be obtained from the participants.</p>
            </sec>
        </sec>
        <sec id="sec14" sec-type="discussion">
            <title>Discussion</title>
            <p>Reduced respiratory muscle tone has been linked with decreased functional capacity in cardiac operations patients, which leads to a protracted period of lung function recovery as well as the commencement of physical deconditioning that can last several weeks.
                <sup>
                    <xref ref-type="bibr" rid="ref21">21</xref>
                </sup> Changes in lung sizes and capabilities, alveolar dysfunction, depression of central respiratory stimulation, and mechanical disorders of thoracic function all contribute to RMS changes.
                <sup>
                    <xref ref-type="bibr" rid="ref22">22</xref>
                </sup>
                <sup>,</sup>
                <sup>
                    <xref ref-type="bibr" rid="ref23">23</xref>
                </sup>
            </p>
            <p>Furthermore, it is well known that the majority of cardiac surgery patients have preoperative bouts of muscular weakness, which is increased after the surgery.
                <sup>
                    <xref ref-type="bibr" rid="ref24">24</xref>
                </sup> However, although the respiratory muscles are similarly passive, they are weaker than the peripheral muscles.
                <sup>
                    <xref ref-type="bibr" rid="ref24">24</xref>
                </sup>
                <sup>,</sup>
                <sup>
                    <xref ref-type="bibr" rid="ref25">25</xref>
                </sup> Following coronary artery bypass graft (CABG) surgery, patients may experience postoperative pulmonary complications (PPCs) are a significant cause of morbidity and death, as well as an increase in hospital stay and resource utilization.
                <sup>
                    <xref ref-type="bibr" rid="ref26">26</xref>
                </sup>
                <sup>,</sup>
                <sup>
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                </sup>
            </p>
            <p>Adele Cook et al. (2023) studied the effect of Preoperative threshold inspiratory muscle training in adults undergoing cardiac surgery. According to the study, preoperative threshold inspiratory muscle training has the potential to minimize the postoperative duration of hospital stay and pulmonary complications following heart surgery.
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            <p>Xiaoyu Chen et al. (2019) undertook a study to see if short-term rigorous preoperative inspiratory muscle training could reduce the occurrence of postoperative pulmonary problems in patients undergoing heart surgery. The study concluded that a 5-day intense schedule of preoperative inspiratory muscle training reduced the frequency and duration of postoperative hospitalization in patients undergoing heart surgery.
                <sup>
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            <p>Thayse Campos de Menezes et al. (2018) conducted a study to evaluate the effect of respiratory and peripheral muscle strength after cardiac surgery. According to study findings after cardiac surgery, there is a decline in respiratory and peripheral muscle strength.
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                    <xref ref-type="bibr" rid="ref30">30</xref>
                </sup>
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            <p>Alquaimi M et al. (2017) conducted a study on pulmonary rehabilitation program (PRP) in ILD patients. This study revealed that IMT in ILD patients improved 6MWD, Fatigue severity scale (FSS) and MIP.
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            <p>Kazuki Okura et al. (2016) conducted a study on the efficacy of moderate-intensity, short-duration inspiratory muscle training in COPD patients. According to the study finding it enhances PImax and exercise capacity in older COPD patients.
                <sup>
                    <xref ref-type="bibr" rid="ref32">32</xref>
                </sup>
            </p>
            <p>B&#x00e1;rbara Maria Hermes et al. (2015) studied the effects of a short-term inspiratory muscle training program combined with aerobic and resistance exercise on respiratory muscle strength, functional capacity, and quality of life in patients who had coronary artery bypass surgery. This concludes that inspiratory muscle training used for shorter periods had the potential to improve respiratory muscle strength, and functional capacity in coronary artery bypass surgery.
                <sup>
                    <xref ref-type="bibr" rid="ref21">21</xref>
                </sup>
            </p>
            <sec id="sec15">
                <title>Ethical considerations</title>
                <p>This study was approved by Datta Meghe Institute of Higher Education on 21 March 2023 (DMIHER (DU)/IEC/2023/545).</p>
                <p>Written informed consent will be obtained from the participants.</p>
            </sec>
        </sec>
    </body>
    <back>
        <sec id="sec18" sec-type="data-availability">
            <title>Data availability</title>
            <sec id="sec19">
                <title>Underlying data</title>
                <p>No data are associated with this article.</p>
            </sec>
            <sec id="sec20">
                <title>Reporting guidelines</title>
                <p>Figshare: SPIRIT checklist for &#x2018;Efficacy of POWERbreathe Medic Plus device on maximal inspiratory pressure, functional capacity and quality of life in coronary artery bypass graft patients: A randomized controlled trial protocol&#x2019;,

                    <ext-link ext-link-type="uri" xlink:href="https://doi.org/10.6084/m9.figshare.24504175.v1">10.6084/m9.figshare.24504175.v1</ext-link>.
                    <sup>

                        <xref ref-type="bibr" rid="ref33">33</xref>
</sup>
                </p>
                <p>Data are available under the terms of the 
                    <ext-link ext-link-type="uri" xlink:href="https://creativecommons.org/licenses/by/4.0/">Creative Commons Attribution 4.0 International license</ext-link> (CC-BY 4.0).</p>
            </sec>
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