Effects of Segmental Breathing Exercise in Patients Awaiting Coronary Artery Bypass Graft Surgery (CABG)

Complications Due to Coronary Artery Bypass Graft Clinical Trial

Official title:

Effects of Preoperative Segmental Breathing Exercise on Postoperative Pulmonary Complications in Patients Awaiting Coronary Artery Bypass Graft Surgery (CABG)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05585138
• Other study ID #: REC/0345 Munaza Tabassum
• Status: Completed
• Phase: N/A
• Start date: May 2, 2022
• Est. completion date: August 26, 2022

Study information

• Verified date: June 2023
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: August 26, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Complications Due to Coronary Artery Bypass Graft
• Respiratory Aspiration

Intervention

Other:
• segmental breathing exercise
Group-A (interventional group) will receive segmental breathing exercises and deep breathing. segmental breathing exercise will be performed by taking a deep and long breath from nose patient inhale air in to lungs and in exhalation therapist will apply pressure on intercostal spaces at apical, lateral and posterior 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 2 times a day.
• deep breathing
conventional treatment will be for one month 5 days a week 10 to 15 repetitions of deep breathing exercise 2 times a day. . deep breathing exercise will be performed by taking a deep and long breath from nose patient inhale air in to lungs and will exhale through mouth.

Locations

Country	Name	City	State
Pakistan	Faisalabad institute of cardiology	Faisalabad	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (18)

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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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in 6 minute walk test	The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.It measures the walking distance of subjects within a fixed time to quantify the functional capacity of the subjects, which refers to the total distance the subjects walked within 6 minutes.	baseline and week 5
Primary	Change in Modified Borg Dyspnea Scale	The Modified Borg Dyspnea Scale (MBS) is a 0 to 10 rated numerical score used to measure dyspnea as reported by the patient during submaximal exercise and is routinely administered during six-minute walk testing (6MWT). It starts at number 0 where your breathing is causing you no difficulty at all and progresses through to number 10 where your breathing difficulty is maximal.	baseline and week 5
Primary	Change in short form-12 Health related quality of life questionnaire	It is a self-reported outcome measure assessing the impact of health on an individual's everyday life. The SF-12v2 is a health-related quality-of-life questionnaire consisting of twelve questions that measure eight health domains to assess physical and mental health. Physical health-related domains include General Health (GH), Physical Functioning (PF), Role Physical (RP), and Body Pain (BP). short form-12 questionnaire will be used to measure quality of life in CABG patients. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.	baseline and week 5