The Safe Early Mobilization on CABG

November 28, 2025 updated by: Hulya BULUT

The Effect of the Safe Early Mobilization Protocol Developed for Patients Underwent Coronary Artery Bypass Graft Surgery on Patient Outcomes

Aim: This study aimed to evaluate the effect of a Safe Early Mobilization Protocol (SEMP) developed for patients undergoing coronary artery bypass graft (CABG) surgery on patient outcomes.

Design: A single-center, parallel-group, randomized controlled trial. Methods: The study was conducted with 60 patients in 2023. The intervention group received a Safe Early Mobilization Protocol including bedside elevation, deep breathing and coughing exercises, sitting upright in bed, sitting on the edge of the bed, standing, ambulation, and sitting in a bedside chair from the day of surgery until the fourth postoperative day. The control group received routine mobilization care. Respiratory parameters, orthostatic hypotension (OH), orthostatic intolerance (OI), mobilization distance, anxiety level, and hospital stay were evaluated.

Study Overview

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • 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 Locations

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Hemodynamic stability, defined as:

Resting heart rate <110/min

Mean arterial pressure between 60-110 mmHg

Oxygen saturation (SpO₂) >88%

Receiving dopamine infusion ≤5 mcg/kg/min at the time of enrollment

No auditory, speech, or visual impairments

No neurological contraindications (e.g., cerebrovascular accident [CVA], ataxia, multiple sclerosis [MS])

No orthopedic contraindications that prevent mobilization (e.g., fractures or sequelae)

Provided informed consent to participate in the study

Age ≥18 years

Able to speak Turkish

Literate patients

Exclusion Criteria:

Requirement for intra-aortic balloon pump (IABP) support

Postoperative cerebrovascular events

High-dose inotropic drug infusion in the early postoperative period:

Dopamine ≥10 mcg/kg/min

Norepinephrine ≥0.5 mcg/kg/min

Concurrent dopamine and norepinephrine infusion

Severe arrhythmias preventing mobilization, including:

Sinus tachycardia ≥120/min

Rapid atrial fibrillation

Ventricular tachycardia

Ventricular fibrillation

Advanced chronic obstructive pulmonary disease (COPD) or bronchiectasis

Diagnosed anxiety disorders

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SEMP
A safe early mobilization protocol developed by the researchers was applied.
This protocol was developed to guide the early postoperative mobilization of patients undergoing coronary artery bypass graft surgery, covering the period from the day of surgery to the fourth postoperative day. Prior to mobilization, patients are evaluated using a checklist ensuring physical and environmental safety. On the day of surgery, following extubation by the responsible physician, six stages are applied: bed head elevation, deep breathing exercises, incentive spirometry, passive range of motion (ROM) exercises, sitting upright (90°), and sitting on the edge of the bed. On postoperative days 1-3, standing at the bedside, ambulation, and sitting on a chair are added. Target walking distances are 100-150 m on day 1, 200-250 m on day 2, and 300-350 m on day 3. Distances are measured by the researcher using a meter. The protocol concludes on the 4th postoperative day when the patient can ambulate independently.
Active Comparator: Control group
The routine protocol used in the hospital was applied.
Patients in the control group were informed about the current mobilization practices applied in the clinic before surgery. The morning after the surgery (the first day after the surgery), the patient is first seated in the bed, and in the second stage, he is made to sit on the edge of the bed with his feet touching the floor and is observed. In the third stage, the patient stands in an upright position and if there is no dizziness or blackout, the patient is seated on a chair next to the bed. The duration of sitting in the chair is determined depending on the general condition of the patient (pain, dizziness, blackout, nausea). On the 2nd and 3rd postoperative day, patients were contacted by nurses and care support staff while they had a chest tube; Then, the patient is mobilized only with his/her relative. There is no standard practice regarding how long patients should be mobilized during the day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Orthostatic Hypotension
Time Frame: Daily postoperative measurements for up to 3 days.
Orthostatic hypotension defined as a ≥20 mmHg decrease in systolic BP and/or ≥10 mmHg decrease in diastolic BP.
Daily postoperative measurements for up to 3 days.
Number of Participants With Orthostatic Intolerance
Time Frame: Daily postoperative assessments for up to 3 days.
Orthostatic intolerance defined as the presence of dizziness, nausea, weakness, blurred vision, or syncope.considered as OI.
Daily postoperative assessments for up to 3 days.
Oxygen Saturation Level (%)
Time Frame: Daily postoperative measurements for up to 3 days.
Peripheral oxygen saturation (SpO₂) measured using pulse oximetry.
Daily postoperative measurements for up to 3 days.
State Anxiety Scale Score
Time Frame: Postoperative day 1 and postoperative day 4.
The State Anxiety Inventory (STAI-S) will be used (score range: 20-80; higher scores indicate worse anxiety).
Postoperative day 1 and postoperative day 4.
Six-Minute Walk Test Distance (Meters)
Time Frame: Postoperative day 4.
Distance walked during the Six-Minute Walk Test (0-∞ meters; higher distance indicates better functional capacity).
Postoperative day 4.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of Hospital Stay (Days)
Time Frame: From postoperative day 0 until hospital discharge (up to 30 days).
Total duration of postoperative hospitalization, including ICU and ward stay.
From postoperative day 0 until hospital discharge (up to 30 days).

Collaborators and Investigators

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

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 (Actual)

October 1, 2023

Primary Completion (Actual)

December 29, 2023

Study Completion (Actual)

December 29, 2023

Study Registration Dates

First Submitted

November 18, 2025

First Submitted That Met QC Criteria

November 28, 2025

First Posted (Actual)

December 11, 2025

Study Record Updates

Last Update Posted (Actual)

December 11, 2025

Last Update Submitted That Met QC Criteria

November 28, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data will be shared when the study is published.

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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