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Completed

NCT Number: NCT05736770

Pre-operative Respiratory Rehabilitation 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.

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Key information

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Muhammad ali awan

Rawalpindi, Punjab Province, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Respiratory rehabilitation and out of bed mobilization

Other

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

Other

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

Primary outcomes

  1. Forced expiratory volume in one second (FEV1)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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 outcomes

  1. 6-minute walk test (6MWT)

    Time frame: 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

    Time frame: 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".

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 21, 2023
Registry last updated
Sep 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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