NCT05684679

Brief Summary

The rate of pulmonary complications following Coronary artery bypass graft (CABG) is high. Early pulmonary exercises are important in preventing this complication following cardiac surgery. This study aimed to investigate the effectiveness of incentive spirometer (IS) and diaphragmatic breathing exercise (DBE) on the alteration of arterial blood gas (ABG) measures. The study was based on a two-arm, parallel-group, randomized comparative design. Thirty patients who underwent CABG enrolled in the study based on inclusion and exclusion criteria, randomly allocated into either of the groups, IS Group or DBE Group. IS Group and DBE Group underwent chest physiotherapy with IS and DBE, respectively. ABG measures, including PH of blood, partial pressure of arterial oxygen molecule (PaO2), and partial pressure of arterial carbon dioxide (PaCO2), was assessed using an ABG analyzer at baseline (pre-operation), day1 post-operation, and day2 post-operation. The significance level was kept constant for all statistical analyses at 95%.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2019

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2019

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2019

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

January 4, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 13, 2023

Completed
Last Updated

January 18, 2023

Status Verified

January 1, 2023

Enrollment Period

4 months

First QC Date

January 4, 2023

Last Update Submit

January 13, 2023

Conditions

Post Coronary Artery Bypass Grafting

Keywords

Chest PhysiotherapyIncentive spirometerDiaphragmatic breathing

Outcome Measures

Primary Outcomes (3)

  • PH of Blood

    PH of blood was assessed using an ABG analyzer machine

    3 Days

  • Partial pressure of Arterial Oxygen molecule (PaO2)

    PaO2 was assessed using an ABG analyzer machine

    3 Days

  • Partial pressure of Arterial Carbon dioxide molecule (PaCO2)

    PaCO2 was assessed using an ABG analyzer machine

    3 Days

Study Arms (2)

IS Group

EXPERIMENTAL

• Patients were instructed to utilize an incentive spirometer in the sitting or half lying position as taught preoperatively. * 3 to 5 consecutive breath with the spirometer were interspersed between period of quite breathing. * Duration 10-15 minutes/session.

Other: Incentive spirometer plus Chest physiotherapy

DBE Group

EXPERIMENTAL

• Patients were advised to do diaphragmatic breathing exercise in the sitting or half lying position as taught preoperatively. * 3 to 5 consecutive deep breath were interspersed between period of quite breathing. * Duration 10-15 minutes/session.

Other: Diaphragmatic breathing exercise plus Chest physiotherapy

Interventions

Incentive spirometer plus Chest physiotherapyOTHER

Incentive spirometer was given to IS group. However, a conventional chest physiotherapy was given to both groups in the optimal position.

Also known as: Huffing, Coughing, Upper and lower limbs active exercises
IS Group
Diaphragmatic breathing exercise plus Chest physiotherapyOTHER

Diaphragmatic breathing exercise was given to DBE group. In addition, a conventional chest physiotherapy was given in the optimal position.

Also known as: Huffing, Coughing, Upper and lower limbs active exercises
DBE Group

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • The patient with post-CABG,
  • Aged between 40 and 60 years,
  • Had forced expiratory volume in 1 second (FEV1) \<70% of predicted value,
  • Showed FEV1/forced vital capacity (FVC) ratio \>0.8,
  • Weight equal or exceeded the ideal body weight by less than 20%, and
  • Patient co-operation.

You may not qualify if:

  • Aged more than 60 years,
  • Weight equal or exceeded the ideal body weight by more than 20%,
  • Post-operative respiratory treatment exceeding 20 hours,
  • History of Chronic obstructive pulmonary disease (COPD) /thoracic surgery including CABG,
  • had thoracic anomalies/unstable angina,
  • Developed hemodynamic complication, and
  • Non-cooperative/neurological debilitated patient.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rehabilitation Research Chair, Department of Rehabilitation Sciences, king Saud University

Riyadh, Riyadh 11433, 10219, Saudi Arabia

Location

Study Officials

  • AMIR IQBAL, MPT

    King Saud University, Riyadh, Saudi Arabia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prinicipal Investigator

Study Record Dates

First Submitted

January 4, 2023

First Posted

January 13, 2023

Study Start

April 15, 2019

Primary Completion

July 30, 2019

Study Completion

August 25, 2019

Last Updated

January 18, 2023

Record last verified: 2023-01

Locations

SA(1)