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Completed

NCT Number: NCT07276971

The Safe Early Mobilization on CABG

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Guven Hospital

Ankara, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Distance walked during postoperative mobilization

    Time frame: Postoperative Days 1, 2, and 3.

    Distance walked (meters) during routine postoperative mobilization in the hospital corridor, measured using a standardized corridor distance measurement protocol. Greater distances indicate better postoperative mobility.

Secondary outcomes

  1. 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.

  2. 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.

  3. Oxygen Saturation Level (%)

    Time frame: Daily postoperative measurements for up to 3 days.

    Peripheral oxygen saturation (SpO₂) measured using pulse oximetry.

  4. 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).

  5. 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).

  6. 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.

Sponsors and collaborators

Lead sponsor

Hulya BULUT

Other

Collaborators

  • Ankara Guven Hospital
  • Lokman Hekim University

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Dec 11, 2025
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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