Pre-operative Respiratory Rehabilitation in Coronary Artery Bypass Graft Patients

Respiratory Rehabilitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05736770
• Other study ID #: Riphah/RCRS/REC/ 01378
• Status: Completed
• Phase: N/A
• Start date: March 15, 2023
• Est. completion date: August 21, 2023

Study information

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

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: August 21, 2023
• Est. primary completion date: June 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Respiratory Rehabilitation

Intervention

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
• conventional treatment
The conventional exercise program group will perform :Flow based Incentive spirometery, Chest percussion if needed

Locations

Country	Name	City	State
Pakistan	Muhammad ali awan	Rawalpindi	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)