Clinical trial NCT05585138: Effects of Segmental Breathing Exercise in Patients Awaiting Coronary Artery Bypass Graft Surgery (CABG)
Official title: Effects of Preoperative Segmental Breathing Exercise on Postoperative Pulmonary Complications in Patients Awaiting Coronary Artery Bypass Graft Surgery (CABG)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complications Due to Coronary Artery Bypass Graft
Keywords: CABG, segmental breathing, pulmonary complications
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-10-18
Enrollment: 44
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the effects of preoperative segmental breathing exercise on postoperative pulmonary complications in patients awaiting coronary artery bypass graft surgery (CABG).

This study will be a randomized controlled trial. This study will be conducted in cardiac surgery department at Faisalabad institute of cardiology. sample size will be 44including both male and female. Non- probability purposive sampling technique will be used.

Modified healthy heart questionnaire will be used as a screening tool. Baseline, postoperatively before discharge at week 5 assessment will be done by 6-minute walk test. Subjects in group A (interventional group) will be treated using segmental breathing exercises combined with Conventional Treatment (deep breathing exercise ) and the group B (control group) will be treated with only conventional treatment. Group-A (interventional group) will receive segmental breathing exercises for one month 5 days a week and 2 sessions per day for 15 minutes for each patient. conventional treatment will be for one month 5 days a week 10 to 15 repetitions of deep breathing exercise 2times a day. Dyspnea will be checked baselineand at week5 by modified Borg scale.Sputum cup was used for expectoration of sputum . Quality of life will be checked baseline and at week 5by SF-12 Questionnaire. Outcome variables will be 6MWT, dyspnea, quality of life, oxygen saturation, heart rate, blood pressure and expectoration of sputum. Data will be analyzed on SPSS-25.

Detailed description: This study will be a randomized controlled trial. This study will be conducted in cardiac surgery department at Faisalabad institute of cardiology. sample size will be 44including both male and female. Non- probability purposive sampling technique will be used.

Modified healthy heart questionnaire will be used as a screening tool. Baseline, postoperatively before discharge at week 5 assessment will be done by 6-minute walk test. Subjects in group A (interventional group) will be treated using segmental breathing exercises combined with Conventional Treatment (deep breathing exercise ) and the group B (control group) will be treated with only conventional treatment. Group-A (interventional group) will receive segmental breathing exercises for one month 5 days a week and 2 sessions per day for 15 minutes for each patient. conventional treatment will be for one month 5 days a week 10 to 15 repetitions of deep breathing exercise 2times a day. Dyspnea will be checked baselineand at week5 by modified Borg scale.Sputum cup was used for expectoration of sputum . Quality of life will be checked baseline and at week 5by SF-12 Questionnaire. Outcome variables will be 6MWT, dyspnea, quality of life, oxygen saturation, heart rate, blood pressure and expectoration of sputum. Data will be analyzed on SPSS-25.

Eligibility criteria: Inclusion Criteria:

* patients who will be willing to participate in study
* Patient having age 40 to 65 years of age both male and female
* Diagnosed patients of Double vessel coronary artery disease and Triple vessel coronary artery disease
* Controlled diabetic and hypertensive patients.

Exclusion Criteria:

* patient on bronchodilators.
* Left ventricular ejection fraction\< 40 %.
* Valvular disease.
* Patient having dysrhythmias or pacemaker dependent.
* Anemic patient.
* Patient having asthma, chronic obstructive pulmonary disease and interstitial lung disease
* Patient with neurological disorder.

Primary outcomes:
measure: Change in 6 minute walk test
timeFrame: baseline and week 5
measure: Change in Modified Borg Dyspnea Scale
timeFrame: baseline and week 5
measure: Change in short form-12 Health related quality of life questionnaire
timeFrame: baseline and week 5
Secondary outcomes:
Other outcomes:
Locations:
city: Faisalabad
country: Pakistan
facility: Faisalabad institute of cardiology
state: Punjab
Study officials:
affiliation: Riphah International University
name: Sumera Abdul Hameed, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Caliskan E, de Souza DR, Boning A, Liakopoulos OJ, Choi YH, Pepper J, Gibson CM, Perrault LP, Wolf RK, Kim KB, Emmert MY. Saphenous vein grafts in contemporary coronary artery bypass graft surgery. Nat Rev Cardiol. 2020 Mar;17(3):155-169. doi: 10.1038/s41569-019-0249-3. Epub 2019 Aug 27.
citation: Yang J, Biery DW, Singh A, Divakaran S, DeFilippis EM, Wu WY, Klein J, Hainer J, Ramsis M, Natarajan P, Januzzi JL, Nasir K, Bhatt DL, Di Carli MF, Blankstein R. Risk Factors and Outcomes of Very Young Adults Who Experience Myocardial Infarction: The Partners YOUNG-MI Registry. Am J Med. 2020 May;133(5):605-612.e1. doi: 10.1016/j.amjmed.2019.10.020. Epub 2019 Nov 9.
citation: Pooria A, Pourya A, Gheini A. Postoperative complications associated with coronary artery bypass graft surgery and their therapeutic interventions. Future Cardiol. 2020 Sep;16(5):481-496. doi: 10.2217/fca-2019-0049. Epub 2020 Jun 4.
citation: Thybo Karanfil EO, Moller AM. Preoperative inspiratory muscle training prevents pulmonary complications after cardiac surgery - a systematic review. Dan Med J. 2018 Mar;65(3):A5450.
citation: Chen JO, Liu JF, Liu YQ, Chen YM, Tu ML, Yu HR, Lin MC, Lin CC, Liu SF. Effectiveness of a perioperative pulmonary rehabilitation program following coronary artery bypass graft surgery in patients with and without COPD. Int J Chron Obstruct Pulmon Dis. 2018 May 16;13:1591-1597. doi: 10.2147/COPD.S157967. eCollection 2018.
citation: Gomes Neto M, Martinez BP, Reis HF, Carvalho VO. Pre- and postoperative inspiratory muscle training in patients undergoing cardiac surgery: systematic review and meta-analysis. Clin Rehabil. 2017 Apr;31(4):454-464. doi: 10.1177/0269215516648754. Epub 2016 Jul 10.
citation: Cordeiro AL, de Melo TA, Neves D, Luna J, Esquivel MS, Guimaraes AR, Borges DL, Petto J. Inspiratory Muscle Training and Functional Capacity in Patients Undergoing Cardiac Surgery. Braz J Cardiovasc Surg. 2016 Apr;31(2):140-4. doi: 10.5935/1678-9741.20160035.
citation: Alaparthi GK, Amin R, Gatty A, Raghavan H, Bairapareddy KC, Vaishali K, Borghi-Silva A, Hegazy FA. Contrasting effects of three breathing techniques on pulmonary function, functional capacity and daily life functional tasks in patients following valve replacement surgery- A pilot randomized clinical trial. Heliyon. 2021 Jul 22;7(7):e07643. doi: 10.1016/j.heliyon.2021.e07643. eCollection 2021 Jul.
citation: Sahar W, Ajaz N, Haider Z, Jalal A. Effectiveness of Pre-operative Respiratory Muscle Training versus Conventional Treatment for Improving Post operative Pulmonary Health after Coronary Artery Bypass Grafting. Pak J Med Sci. 2020 Sep-Oct;36(6):1216-1219. doi: 10.12669/pjms.36.6.2899.
citation: Moradian ST, Heydari AA, Mahmoudi H. What is the Role of Preoperative Breathing Exercises in Reducing Postoperative Atelectasis after CABG? Rev Recent Clin Trials. 2019;14(4):275-279. doi: 10.2174/1574887114666190710165951.
citation: Zolfaghari M, Mirhosseini SJ, Baghbeheshti M, Afshani A, Moazzam S, Golabchi A. Effect of physiotherapy on quality of life after coronary artery bypass graft surgery: A randomized study. J Res Med Sci. 2018 Jun 6;23:56. doi: 10.4103/jrms.JRMS_96_17. eCollection 2018.
citation: Pehlivan E, Turna A, Gurses A, Gurses HN. The effects of preoperative short-term intense physical therapy in lung cancer patients: a randomized controlled trial. Ann Thorac Cardiovasc Surg. 2011;17(5):461-8. doi: 10.5761/atcs.oa.11.01663. Epub 2011 Jul 13.
citation: Matheus GB, Dragosavac D, Trevisan P, Costa CE, Lopes MM, Ribeiro GC. Inspiratory muscle training improves tidal volume and vital capacity after CABG surgery. Rev Bras Cir Cardiovasc. 2012 Jul-Sep;27(3):362-9. doi: 10.5935/1678-9741.20120063. English, Portuguese.
citation: Savci S, Degirmenci B, Saglam M, Arikan H, Inal-Ince D, Turan HN, Demircin M. Short-term effects of inspiratory muscle training in coronary artery bypass graft surgery: a randomized controlled trial. Scand Cardiovasc J. 2011 Oct;45(5):286-93. doi: 10.3109/14017431.2011.595820. Epub 2011 Jul 27.
citation: Chen YC, Chen KC, Lu LH, Wu YL, Lai TJ, Wang CH. Validating the 6-minute walk test as an indicator of recovery in patients undergoing cardiac surgery: A prospective cohort study. Medicine (Baltimore). 2018 Oct;97(42):e12925. doi: 10.1097/MD.0000000000012925.
citation: Failde I, Medina P, Ramirez C, Arana R. Construct and criterion validity of the SF-12 health questionnaire in patients with acute myocardial infarction and unstable angina. J Eval Clin Pract. 2010 Jun;16(3):569-73. doi: 10.1111/j.1365-2753.2009.01161.x. Epub 2010 Apr 21.
citation: Pacaric S, Turk T, Eric I, Orkic Z, Petek Eric A, Milostic-Srb A, Farcic N, Barac I, Nemcic A. Assessment of the Quality of Life in Patients before and after Coronary Artery Bypass Grafting (CABG): A Prospective Study. Int J Environ Res Public Health. 2020 Feb 22;17(4):1417. doi: 10.3390/ijerph17041417.
citation: Reychler G, Beaumont M, Latiers AC, Pieters T, Fremault A. Dyspnea could be accurately assessed by a caregiver in hospitalized patients with respiratory diseases: Interrater reliability and agreement study. Braz J Phys Ther. 2021 Nov-Dec;25(6):735-740. doi: 10.1016/j.bjpt.2021.04.010. Epub 2021 May 24.