Pre-operative Respiratory Rehabilitation in Coronary Artery Bypass Graft Patients

Effect of Pre-operative Respiratory Rehabilitation on Post- Operative Outcomes in Coronary Artery Bypass Graft Patients

To compare the effects of conventional preoperative respiratory rehabilitation and specific preoperative respiratory rehabilitation program on pulmonary functions in coronary artery bypass graft patients.

Study Overview

• Status: Completed
• Conditions: Respiratory Rehabilitation
• Intervention / Treatment: Other: Respiratory rehabilitation and out of bed mobilization; Other: conventional treatment

Detailed Description

After cardiac surgeries many postoperative changes occur that lead to pulmonary complication such as respiratory changes, functional capacity of lungs and gaseous changes that leads to hypoxemia and ischemic injury of lungs. CABG, although a successful procedure, post operative pulmonary complications still pursue a big challenge to the health and fitness of the patients. Although post operative complications have been managed in in-patient setup post CABG, there are pre-operative measures on the rise to prevent the complications to occur after CABG.

This study will contribute in describing the rate of improvement in pulmonary functions with rehabilitation program including preoperative out of bed mobilization, active cycle breathing techniques, forced expiratory technique and volume-based incentive spirometry as compared to the conventional treatment of flow-based incentive spirometry and chest percussion in prevention of post operative pulmonary complications occurring after CABG leading to delayed recovery of patients.

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Muhammad ali awan, MS-CPPT; Phone Number: +92-333-9131556; Email: ali.awan@riphah.edu.pk
• Study Contact Backup: Name: Aqsa Iqbal, MS-CPPT; Phone Number: +92-318-7058501; Email: aig4075@gmail.com

Study Locations

• Pakistan
  • Punjab
    • Rawalpindi, Punjab, Pakistan
      • Muhammad ali awan
      • Contact: Muhammad ali awan, MS-CPPT; Phone Number: +92-333-9131556; Email: ali.awan@riphah.edu.pk
      • Contact: Aqsa Iqbal, MS-CPPT; Phone Number: +92-318-7058501; Email: aig4075@gmail.com
      • Principal Investigator: Muhammad ali awan, MS-CPPT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients undergoing elective Coronary Artery Bypass Grafting (CABG) surgery for Triple vessel coronary artery disease (TVCAD), double vessel coronary artery disease (DVCAD), single vessel coronary artery disease (SVCAD) and left main stem (LMS) disease.
• Patients who cover at least 400 steps on 6-minute walk test.
• Patients with ejection fraction 45% or more

Exclusion Criteria:

• Acute ailments i.e., patient's cardiac condition deteriorating.
• Cardiac emergency (shock, acute MI)
• Presence of neurological disorders e.g., altered state of consciousness, paralysis.
• Redo surgeries
• Any musculoskeletal disorder e.g., amputation of limb, problems of balance and risks of fall, muscles weakness grade 3 or less, osteoporosis; leading to limitation in exercise.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Respiratory rehabilitation and out of bed mobilization group; The Respiratory rehabilitation and out of bed mobilization group will perform 4 exercises.	Other: Respiratory rehabilitation and out of bed mobilization; The Respiratory rehabilitation and out of bed mobilization group will perform following exercises: pre operative out of bed mobilization, active cycle breathing techniques, forced expiratory technique and volume based incentive spirometery
Active Comparator: Conventional exercise program group; The conventional exercises program will perform conventional exercises	Other: conventional treatment; The conventional exercise program group will perform :Flow based Incentive spirometery, Chest percussion if needed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Forced expiratory volume in one second (FEV1)	The Forced Expiratory Volume in 1 Second parameter measures the volume of air that was exhaled into the mouthpiece in the first second after a full inhalation. The normal test values range between 80% and 120% of the average (predicted) values.	4th postoperative day of coronary artery bypass graft (CABG)
Forced Vital Capacity (FVC)	Forced Vital Capacity measures the total volume of air that you were able to blow forcefully into the mouthpiece following a full inhalation	4th postoperative day of coronary artery bypass graft (CABG)
Ratio of Forced expiratory volume in 1 second and Forced Vital Capacity (FEV1/FVC)	FEV1/FVC: The FEV1/FVC Ratio (FEV1%) parameter is calculated by dividing the measured FEV1 value by the measured FVC value. In healthy adults of the same gender, height, and age, the normal Predicted percentage should be between 70% and 85.	4th postoperative day of coronary artery bypass graft (CABG)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6-minute walk test (6MWT)	six minutes walk test (6MWT) is test used to measure functional exercise capacity of patients with cardiovascular and/or pulmonary disease. In this test, patient performs walk for 6 minutes while time being counted on stopwatch. The patient can take rest between the walk, but the timer keeps on running and the rest period is counted. At the end of the test, patient's level of exertion is noted, and the distance measured is recorded. The 6MWT distance values for a healthy person are 400-700m.	4th postoperative day of coronary artery bypass graft (CABG)
Borg scale	The Borg Rating of Perceived Exertion (RPE) scale is a tool for measuring an individual's effort and exertion, breathlessness and fatigue during physical work. Patients are asked to tell the whole feeling of exertion including leg pain and shortness of breath and it is marked on a number from 6-20, where 6 indicates "no exertion at all" and 20 indicates "maximal exertion".	4th postoperative day of coronary artery bypass graft (CABG)

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Muhammad Ali Awan, MS-CPPT, Riphah International University

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2023
• Primary Completion (Actual): June 10, 2023
• Study Completion (Actual): August 21, 2023

Study Registration Dates

• First Submitted: January 13, 2023
• First Submitted That Met QC Criteria: February 20, 2023
• First Posted (Actual): February 21, 2023

Study Record Updates

• Last Update Posted (Actual): September 1, 2023
• Last Update Submitted That Met QC Criteria: August 31, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: Riphah/RCRS/REC/ 01378

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