Pre-operative Respiratory Rehabilitation in Coronary Artery Bypass Graft Patients

Sponsor
Riphah International University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05736770
Collaborator
(none)
100
1
2
10.1
9.9

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Respiratory rehabilitation and out of bed mobilization
  • Other: conventional treatment
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Effect of Pre-operative Respiratory Rehabilitation on Post- Operative Outcomes in Coronary Artery Bypass Graft Patients
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Forced expiratory volume in one second (FEV1) [4th postoperative day of coronary artery bypass graft (CABG)]

    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.

  2. Forced Vital Capacity (FVC) [4th postoperative day of coronary artery bypass graft (CABG)]

    Forced Vital Capacity measures the total volume of air that you were able to blow forcefully into the mouthpiece following a full inhalation

  3. Ratio of Forced expiratory volume in 1 second and Forced Vital Capacity (FEV1/FVC) [4th postoperative day of coronary artery bypass graft (CABG)]

    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.

Secondary Outcome Measures

  1. 6-minute walk test (6MWT) [4th postoperative day of coronary artery bypass graft (CABG)]

    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.

  2. Borg scale [4th postoperative day of coronary artery bypass graft (CABG)]

    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".

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Muhammad ali awan Rawalpindi Punjab Pakistan

Sponsors and Collaborators

  • Riphah International University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Riphah International University
ClinicalTrials.gov Identifier:
NCT05736770
Other Study ID Numbers:
  • Riphah/RCRS/REC/ 01378
First Posted:
Feb 21, 2023
Last Update Posted:
Feb 21, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Feb 21, 2023