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

June 26, 2023 updated by: Riphah International University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Faisalabad, Punjab, Pakistan, 38000
        • Faisalabad institute of cardiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

36 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Segmental breathing exercise

segmental 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
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.
Other: 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.
Active Comparator: conventional therapy
Conventional 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in 6 minute walk test
Time Frame: baseline and week 5
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
Change in Modified Borg Dyspnea Scale
Time Frame: baseline and week 5
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
Change in short form-12 Health related quality of life questionnaire
Time Frame: baseline and week 5
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
duration of oxygen therapy.
Time Frame: week 5
For how many hours patient received oxygen therapy during hospital stay after CABG.
week 5
The length of icu stay
Time Frame: week 5
how many days patient stay in icu after CABG.The average ICU length of stay (LOS) is 3.3 days, and for every day spent in an ICU bed, the average patient spends an additional 1.5 days in a non-ICU bed.
week 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: sumera abdul hameed, Ms, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2022

Primary Completion (Actual)

August 1, 2022

Study Completion (Actual)

August 26, 2022

Study Registration Dates

First Submitted

September 15, 2022

First Submitted That Met QC Criteria

October 17, 2022

First Posted (Actual)

October 18, 2022

Study Record Updates

Last Update Posted (Actual)

June 28, 2023

Last Update Submitted That Met QC Criteria

June 26, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/0345 Munaza Tabassum

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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