The Safe Early Mobilization on CABG

NCT07276971 | Completed

• 1 other identifier: 36970
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Bypass Graft; Nursing

Keywords

Coronary artery bypass graft; Cardiovascular nursing; Early mobilization protocol; Patient outcomes

Outcome Measures

Primary Outcomes (5)

• Number of Participants With Orthostatic Hypotension

  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

  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 (%)

  Peripheral oxygen saturation (SpO₂) measured using pulse oximetry.

  Daily postoperative measurements for up to 3 days.

• State Anxiety Scale Score

  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)

  Distance walked during the Six-Minute Walk Test (0-∞ meters; higher distance indicates better functional capacity).

  Postoperative day 4.

Secondary Outcomes (1)

• Length of Hospital Stay (Days)

  From postoperative day 0 until hospital discharge (up to 30 days).

Study Arms (2)

SEMP

EXPERIMENTAL

A safe early mobilization protocol developed by the researchers was applied.

Other: The safe early mobilization protocol

Control group

ACTIVE COMPARATOR

The routine protocol used in the hospital was applied.

Other: Control Group

Interventions

Control Group OTHER

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.

Control group

The safe early mobilization protocol OTHER

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.

SEMP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hulya BULUT: lead
• Lokman Hekim University: collaborator
• Ankara Guven Hospital: collaborator

Study Sites (1)

Guven Hospital

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 11, 2025
• Study Start: October 1, 2023
• Primary Completion: December 29, 2023
• Study Completion: December 29, 2023
• Last Updated: December 11, 2025

Record last verified: 2025-11

Locations

TU (1)