Incentive Spirometry Versus Inspiratory Muscle Training After Coronary Artery Bypass Grafting (IS/ IMT)

January 20, 2026 updated by: Eman Abdelmohsen Ismail Hassan, Cairo University

Effect of Incentive Spirometry Versus Inspiratory Muscle Training on Arterial Blood Gases After Coronary Artery Bypass Grafting

This study will be conducted to compare between incentive spirometry verses inspiratory muscle training preoperatively on (ABG) after coronary artery bypass graft surgery.

Is there any significant difference of preoperative incentive spirometry verses inspiratory muscle training on Arterial blood gases (ABG) after coronary artery bypass graft surgery?

Participants will:

Group A (incentive spirometry group ) Group B (Inspiratory muscle trainer group ) for 5 days before operative Group C (control group) and group a , b will have routinely postoperative

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Egypt
    • Alsharqia
      • Zagazig, Alsharqia, Egypt, 44519
        • Zagazig university hospitals
        • Contact:
          • principle investigator
          • Phone Number: +200552304832
          • Email: info@zu.edu.eg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 45 male patients will be included in this study.
  • Patients with age from 50 to 60 years old (undergoing coronary artery bypass graft surgery) through median sternotomy.
  • Their body mass index from 25 to 29.9 kg/m2
  • Patients will be alert and able to follow instruction.

Exclusion Criteria:

  • Who are expected not to be able to conduct or comply with IS and IMT.
  • Patients with cognitive or neurological deficits.
  • Patients with coexisting acute or chronic respiratory disorders.
  • Patients unable to understand or show the proper use of the incentive spirometer and Inspiratory muscle training .
  • Patients who cannot be instructed or supervised to assure appropriate use of the device patients in whom cooperation is absent or patients unable to understand or demonstrate proper use of the devices (inspiratory muscle training and incentive spirometry).
  • Patients who are confused or delirious.
  • Patients undergoing any other surgery along with CABG.
  • Patients undergoing emergency CABG surgery.
  • Chronic obstructive pulmonary disease (COPD), asthma, restrictive lung disease, preoperative major chest infection e.g. pulmonary tuberculosis, chest deformities such as pectus carinatum, pectus excavatum, thoracolumbar scoliosis, diaphragmatic hernias diagnosed on history.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: IS
This group will include 15 patients, Incentive spirometry was utilized by the patient with ten breaths, six sets per day for a period of 10 min within patient tolerance in every session for five days with routinely physical therapy program (education and explanation) preoperatively, And postoperatively treatment (breathing treatment, deep-breathing applications, guided coughing, early mobilization).
Device: Incentive spirometry
This group will include 15 patients, Incentive spirometry was utilized by the patient with ten breaths, six sets per day for a period of 10 min within patient tolerance in every session for five days with routinely physical therapy program (education and explanation) preoperatively, And postoperatively treatment (breathing treatment, deep-breathing applications, guided coughing, early mobilization).
Other Names:
  • IS
Experimental: IMT
This group will include 15 patients, each session consisted of 30 minutes of inspiratory muscle training. The patients were trained to use an inspiratory threshold-loading device (Threshold Inspiratory Muscle Training) for five days with routinely physical therapy program (education and explanation) preoperatively, And postoperatively treatment (breathing treatment, deep-breathing applications, guided coughing, early mobilization).
Device: Inspiratory muscle trainer
This group will include 15 patients, each session consisted of 30 minutes of inspiratory muscle training. The patients were trained to use an inspiratory threshold-loading device (Threshold Inspiratory Muscle Training) for five days with routinely physical therapy program (education and explanation) preoperatively, And postoperatively treatment (breathing treatment, deep-breathing applications, guided coughing, early mobilization).
Other Names:
  • IMT
Active Comparator: Control group
15 patients will receive for 5 days routinely physical therapy program (education and explanation) preoperatively, And postoperatively treatment (breathing treatment, deep-breathing applications, guided coughing, early mobilization).
Other: Routine physical therapy
15 patients will receive for 5 days routinely physical therapy program (education and explanation) preoperatively, And postoperatively treatment (breathing treatment, deep-breathing applications, guided coughing, early mobilization).
Other Names:
  • Control group

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Arterial Blood gas Parameters (PaO2 and SaO2)
Time Frame: Baseline 5 days pre-surgery , Immediately after the surgery within 48 hours , and through study completion an average of 8 days.
Assessment of arterial oxygenation changes by measuring PaO2 and SaO2 . data will be collected at Baseline pre-surgery (5 days ) , Immediately after the surgery (within 48 hours) , and through study completion an average of 8 days.to evaluate the recovery trend and the effectiveness of respiratory interventions.
Baseline 5 days pre-surgery , Immediately after the surgery within 48 hours , and through study completion an average of 8 days.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Atelactasis
Time Frame: Baseline 5 days pre-surgery, Immediately after the surgery within 48 hours, and through study completion an average of 8 days.
Assessment of lung collapse using chest X-ray and CT or clinical findings.
Baseline 5 days pre-surgery, Immediately after the surgery within 48 hours, and through study completion an average of 8 days.
Functional capacity (2- minute walk test)
Time Frame: Baseline 5 days pre-surgery, and through study completion an average of 8 days.
measuring the maximum distance a patient can walk on a flat surface in 2-minutes to evaluate functional exercise capacity.
Baseline 5 days pre-surgery, and through study completion an average of 8 days.
Physical function ICU test - scored (PFIT-s)
Time Frame: Immediately after the surgery within 48 hours.
Assessment of physical function in the ICU through four components ( sit -to- stand, marching, shoulder flexion, and knee extension ) Scored (0 - 10).
Immediately after the surgery within 48 hours.
Mechanical Ventilation duration
Time Frame: from the end of surgery until successful extubation .
the total number of hours the patient required mechanical ventilation support after CABG surgery
from the end of surgery until successful extubation .

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 6, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 26, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 26, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P.T.REC/012/006065

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

data is available with a corresponding offer on reasonable request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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