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

Primary Purpose

Complications Due to Coronary Artery Bypass Graft

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
segmental breathing exercise
deep breathing
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Complications Due to Coronary Artery Bypass Graft focused on measuring CABG, segmental breathing, pulmonary complications

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Faisalabad institute of cardiology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Segmental breathing exercise

conventional therapy

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
September 15, 2022
Last Updated
June 26, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05585138
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
May 2, 2022 (Actual)
Primary Completion Date
August 1, 2022 (Actual)
Study Completion Date
August 26, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complications Due to Coronary Artery Bypass Graft
Keywords
CABG, segmental breathing, pulmonary complications

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Segmental breathing exercise
Arm Type
Experimental
Arm Description
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
Arm Title
conventional therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
segmental breathing exercise
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
deep breathing
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in 6 minute walk test
Description
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.
Time Frame
baseline and week 5
Title
Change in Modified Borg Dyspnea Scale
Description
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.
Time Frame
baseline and week 5
Title
Change in short form-12 Health related quality of life questionnaire
Description
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.
Time Frame
baseline and week 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sumera Abdul Hameed, MS
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faisalabad institute of cardiology
City
Faisalabad
State/Province
Punjab
ZIP/Postal Code
38000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
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Effects of Segmental Breathing Exercise in Patients Awaiting Coronary Artery Bypass Graft Surgery (CABG)

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