AzTrials
AzTrials

Complications Due to Coronary Artery Bypass GraftNCT05585138

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

A study testing segmental breathing exercise and deep breathing in people with Complications Due to Coronary Artery Bypass Graft, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 40 to 65 years
What is being tested?
segmental breathing exercise and deep breathing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 sitePakistan
Study dates
2 May 2022to 26 Aug 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Faisalabad institute of cardiology

    Faisalabad, Punjab Province, 38000

Other trials in Pakistan

About this study

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

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.

Read the 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.

Being tested
segmental breathing exercise, deep breathing
Keywords
CABG, segmental breathing, pulmonary complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • segmental breathing exerciseOther

    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 breathingOther

    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.

Study groups in NCT05585138
Study groupRoleWhat they receive
Segmental breathing exerciseExperimentalsegmental breathing exercise (apical costal expansion exercises, lateral costal expansion exercises, posterior costal expansion exercises) combined with Conventional Treatment ( deep breathing exercise ). 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
Receives: Other: segmental breathing exercise; Other: deep breathing
conventional therapyActive comparatorConventional Treatment (deep breathing exercise). conventional treatment will be for one month 5 days a week 10 to 15 repetitions of deep breathing exercise 2times a day.
Receives: Other: deep breathing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: baseline and week 5

  2. 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.

    Measured: baseline and week 5

  3. 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.

    Measured: baseline and week 5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2022
  2. Study start2 May 2022
  3. Primary completion1 Aug 2022
  4. Study completion26 Aug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05585138
Sponsor's protocol ID
REC/0345 Munaza Tabassum
Status last verified
Jun 2023
First submitted
15 Sep 2022
Last updated
28 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31455868
  • 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.

    PubMed 31715169
  • 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.

    PubMed 32495650
  • 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.

    PubMed 29510803
  • 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.

    PubMed 29805258
  • 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.

    PubMed 27154820
  • 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.

    PubMed 27556313
  • 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.

    PubMed 34377862
  • 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.

    PubMed 32968383
  • 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.

    PubMed 31291879
  • 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.

    PubMed 30057640
  • 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.

    PubMed 21881371
  • 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.

    PubMed 23288176
  • 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.

    PubMed 21793631
  • 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.

    PubMed 30335028

Questions about this trial

What is this clinical trial studying?

A study testing segmental breathing exercise and deep breathing in people with Complications Due to Coronary Artery Bypass Graft, run by Riphah International University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in 6 minute walk test (time frame: baseline and week 5). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05585138, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2023.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in