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CompletedNCT05736770Updated Sep 1, 2023

Pre-operative Respiratory Rehabilitation in Coronary Artery Bypass Graft Patients

An interventional study of Respiratory rehabilitation and out of bed mobilization and conventional treatment in Respiratory Rehabilitation, sponsored by Riphah International University. Completed at 1 site in Pakistan. Open to participants aged 40 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-09-01.

Sponsored by Riphah International University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
86
Allocation
Randomized
Ages
40 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Respiratory Rehabilitation
03

In context

Lead sponsor

Riphah International University is the lead sponsor of 2,133 studies on the registry; 633 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 65 Years
Sexes eligible
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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
86 participants (actual)

Study arms

  • 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

  • Active comparator
    Conventional exercise program group

    The conventional exercises program will perform conventional exercises

    Other: conventional treatment

Interventions

  • OtherRespiratory 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

  • Otherconventional treatment

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 4th postoperative day of coronary artery bypass graft (CABG)

  2. 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

    Time frame: 4th postoperative day of coronary artery bypass graft (CABG)

  3. 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.

    Time frame: 4th postoperative day of coronary artery bypass graft (CABG)

Secondary outcomes

  1. 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.

    Time frame: 4th postoperative day of coronary artery bypass graft (CABG)

  2. 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".

    Time frame: 4th postoperative day of coronary artery bypass graft (CABG)

07

Study locations

1 site
  • Muhammad ali awan
    Rawalpindi, Punjab, Pakistan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05736770
Lead sponsor
Riphah International University
Responsible party
Sponsor
First posted
Feb 21, 2023
Start date
Mar 15, 2023
Primary completion
Jun 10, 2023
Completion
Aug 21, 2023
Last update
Sep 1, 2023

Study contacts

Muhammad Ali Awan, MS-CPPT
principal investigator · Riphah International University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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