The Safe Early Mobilization on CABG (NCT07276971) | Clinical Trial Compass
CompletedNot Applicable
The Safe Early Mobilization on CABG
Turkey (Türkiye)60 participantsStarted 2023-10-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Orthostatic Hypotension
Timeframe: Daily postoperative measurements for up to 3 days.
2
Number of Participants With Orthostatic Intolerance
Timeframe: Daily postoperative assessments for up to 3 days.
3
Oxygen Saturation Level (%)
Timeframe: Daily postoperative measurements for up to 3 days.
4
State Anxiety Scale Score
Timeframe: Postoperative day 1 and postoperative day 4.