NCT07367945

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2026

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 26, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

September 1, 2026

Status Verified

December 1, 2025

Enrollment Period

3 months

First QC Date

January 6, 2026

Last Update Submit

August 28, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Arterial Blood gas Parameters (PaO2 and SaO2)

    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.

  • Numerical rating pain scale

    Pain Scale for Pain Assessment. 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 Outcomes (2)

  • Functional capacity (2- minute walk test)

    Baseline 5 days pre-surgery, and through study completion an average of 8 days.

  • Physical function ICU test - scored (PFIT-s)

    Immediately after the surgery within 48 hours.

Study Arms (3)

IS

EXPERIMENTAL

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

IMT

EXPERIMENTAL

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, two times per day. And postoperatively treatment (breathing treatment, deep-breathing applications, guided coughing, early mobilization).

Device: Inspiratory muscle trainer

Control group

ACTIVE COMPARATOR

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

Interventions

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).

Also known as: IS
IS

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).

Also known as: IMT
IMT

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).

Also known as: Control group
Control group

Eligibility Criteria

Age50 Years - 60 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zagazig University Hospitals

Zagazig, Alsharqia, 44519, Egypt

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
physical therapist

Study Record Dates

First Submitted

January 6, 2026

First Posted

January 26, 2026

Study Start

February 1, 2026

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

September 1, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

data is available with a corresponding offer on reasonable request

Locations