Coronary Artery Bypass GraftNCT07276971
The Safe Early Mobilization on CABG
A study testing The safe early mobilization protocol in people with Coronary Artery Bypass Graft and Nursing, run by Hulya BULUT at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Bypass Graft, Nursing
- What is being tested?
- The safe early mobilization protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2023to 29 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Coronary Artery Bypass Graft, Nursing
- Being tested
- The safe early mobilization protocol, Control Group
- Keywords
- Coronary artery bypass graft, Cardiovascular nursing, Early mobilization protocol, Patient outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The safe early mobilization protocolOther
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 GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| SEMP | Experimental | A safe early mobilization protocol developed by the researchers was applied. Receives: Other: The safe early mobilization protocol |
| Control group | Active comparator | The routine protocol used in the hospital was applied. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance walked during postoperative mobilization
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.
Measured: Postoperative Days 1, 2, and 3.
Secondary outcomes (6)
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.
Measured: 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.
Measured: Daily postoperative assessments for up to 3 days.
Oxygen Saturation Level (%)
Peripheral oxygen saturation (SpO₂) measured using pulse oximetry.
Measured: 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).
Measured: 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).
Measured: Postoperative day 4.
Length of Hospital Stay (Days)
Total duration of postoperative hospitalization, including ICU and ward stay.
Measured: From postoperative day 0 until hospital discharge (up to 30 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start1 Oct 2023
- Primary completion29 Dec 2023
- Study completion29 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Bypass GraftStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hulya BULUT
- Sponsor type
- University, hospital or other
- Collaborators
- Lokman Hekim University, Ankara Guven Hospital
- Responsible party
- Sponsor-investigator, Hulya BULUT, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07276971
- Sponsor's protocol ID
- 36970
- Status last verified
- Jul 2026
- First submitted
- 18 Nov 2025
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be shared when the study is published.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Safe Early Mobilization Protocol Developed for Patients Underwent Coronary Artery Bypass Graft Surgery on Patient Outcomes
- ClinicalTrials.gov ID
- NCT07276971
- Acronym / sponsor ID
- 36970
- Conditions
- Coronary Artery Bypass Graft, Nursing
- Keywords
- Coronary artery bypass graft, Cardiovascular nursing, Early mobilization protocol, Patient outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hulya BULUTUniversity, hospital or other
- Collaborators
- Lokman Hekim University, Ankara Guven Hospital
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 29 Dec 2023 (actual)
- Study completion
- 29 Dec 2023 (actual)
- First posted
- 11 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SEMP | Experimental | Other: The safe early mobilization protocolA safe early mobilization protocol developed by the researchers was applied. |
| Control group | Active comparator | Other: Control GroupThe routine protocol used in the hospital was applied. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (13 listed)
- Requirement for intra-aortic balloon pump (IABP) support
- Postoperative cerebrovascular events
- Dopamine ≥10 mcg/kg/min
- Norepinephrine ≥0.5 mcg/kg/min
- Concurrent dopamine and norepinephrine infusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The safe early mobilization protocolThis 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. | Other | SEMP |
| Control GroupPatients 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. | Other | Control group |
Primary outcome
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.
6 secondary outcomes
Number of Participants With Orthostatic Hypotension
Time frame: Daily postoperative measurements for up to 3 days.
Number of Participants With Orthostatic Intolerance
Time frame: Daily postoperative assessments for up to 3 days.
Oxygen Saturation Level (%)
Time frame: Daily postoperative measurements for up to 3 days.
State Anxiety Scale Score
Time frame: Postoperative day 1 and postoperative day 4.
Six-Minute Walk Test Distance (Meters)
Time frame: Postoperative day 4.
Length of Hospital Stay (Days)
Time frame: From postoperative day 0 until hospital discharge (up to 30 days).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: Undecided. Data will be shared when the study is published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The safe early mobilization protocol in people with Coronary Artery Bypass Graft and Nursing, run by Hulya BULUT at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distance walked during postoperative mobilization (time frame: Postoperative Days 1, 2, and 3.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.