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IRCT20151004024342N9 IRCT 2025-11-14 Mazandaran University of Medical Sciences Effect of Early Mobilization after Coronary Artery Bypass Graft surgery The effect of an Early Mobilization program on Functional capacity, Kinesiophobia and Quality of Recovery in patients undergoing Coronary Artery Bypass Graft surgery 2025-12-22 anticipated 60 Recruiting https://irct.ir/trial/87343 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: Post-randomization withdrawal criteria: Hemodynamic instability (requiring simultaneous use of more than one type of inotropic drug, use of intra-aortic balloon pump (IABP), or presence of second- or third-degree AV block), need for reoperation, unstable angina after surgery, cardiac arrest after surgery, unwillingness to continue participation, transfer to another hospital, death of the patient, Randomization description: Randomization will be performed at the individual level using block randomization. After selecting eligible patients through convenience sampling, the random allocation sequence will be generated using the Random Allocation software. The number and size of the blocks will also be determined randomly by the software, based on multiples of 4, 6, and 8.The final randomization list will be prepared before the start of the study, and patients will be allocated to the intervention or control group according to their order of enrollment and in accordance with this sequence, Blinding description: Due to the nature of the intervention, it is not possible to blind the participants and the therapist; however, the assessor responsible for measuring the study outcomes, including functional capacity, kinesiophobia, and quality of recovery, will be blinded and will have no knowledge of the group allocation of the patients. N/A Coronary artery bypass graft (CABG). Intervention 1: Intervention group: Patients in the intervention group, in addition to receiving standard hospital care and routine physiotherapy (including respiratory physiotherapy, limb physiotherapy, incentive spirometry, and use of a vibrator), will participate in an early mobilization program twice daily (morning and evening) from 24 hours after surgery until discharge. On the first day, patients will perform passive range of motion exercises for both upper and lower limbs (8–10 repetitions for each movement) and will sit on the bed for 15 minutes during each session. On the second day, patients will perform active range of motion exercises and sit at the edge of the bed with legs dangling for 10 minutes during each session. On the third day, in addition to the previous activities, after disconnecting monitoring lines and clamping the drains, patients—while being monitored with a portable pulse oximeter and supported by the researcher—will sit on a chair beside the bed for 15 minutes, and if their heart rate and respiratory status are stable, they will walk 20–50 meters beside the bed. On the fourth day, under similar conditions, patients will walk 50–100 meters with the researcher’s support. On the fifth day, patients will walk 100–200 meters independently under the researcher’s supervision and will also climb 3–5 stairs with support. From the sixth day until discharge, patients will, according to their tolerance, increase the walking distance and the number of stairs climbed during each session. Each intervention session will last an average of 30 minutes. Before starting each session, vital signs and pain level will be assessed using the Visual Analogue Scale (VAS) and recorded in the daily intervention checklist. If the patient reports a pain intensity of 4 or higher on the VAS, the researcher will request an analgesic prescription from the physician. After the medication is administered, a waiting period corresponding to the onset of action or, if necessary, half-life duration (based on the pharmacological characteristics of the drug) will be observed. Subsequently, the pain intensity will be reassessed, and if it decreases to below 4, the exercise session will begin. The type, dosage, and frequency of analgesic use, along with the reported pain intensity, will be documented for comparison between groups. The exercise intensity during all sessions will be maintained between 11 and 13 on the Borg Rating of Perceived Exertion (RPE) scale (6–20), corresponding to a light to somewhat hard level of effort. During mobilization out of bed, patients will be monitored using a portable pulse oximeter. If the heart rate increases by more than 20% from baseline or if the oxygen saturation (SpO₂) drops below 90%, the intervention will be terminated for that session. Intervention 2: Control group: Patients in the control group will receive standard hospital care and routine physiotherapy (including respiratory physiotherapy, limb physiotherapy, incentive spirometry, and the use of a vibrator) once daily from the first working day after surgery until hospital discharge. During their stay in the ICU-OH, these patients will not receive any structured or systematic exercise program for gradual mobilization, and getting out of bed will begin only after their transfer to the ward. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information.
public Vida Shafipour
Nasibeh School of Nursing and Midwifery, Vesal Shirazi Street, Amir Mazandarani Boulevard
Sari Iran (Islamic Republic of) 4816715793 +98 11 3379 5552 vidashafipour@yahoo.com Mazandaran University of Medical Sciences scientific Vida Shafipour
Nasibeh School of Nursing and Midwifery, Vesal Shirazi Street, Amir Mazandarani Boulevard
Sari Iran (Islamic Republic of) 4816715793 +98 11 3379 5552 vidashafipour@yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Undergoing coronary artery bypass graft (CABG) surgery Age between 18 and 70 years Completion of the informed consent form Ability to follow the researcher’s instructions 18 years 70 years Both History of previous cardiac surgery History of performing the 6-minute walk test (6MWT) Left ventricular ejection fraction (LVEF) less than 35% Patient being CBR before surgery Presence of known pulmonary disease (chronic obstructive pulmonary disease (COPD), severe refractory asthma, or respiratory failure) presence of movement disorders (limb amputation, balance or gait disturbance, limb weakness, rheumatoid arthritis, or other severe joint diseases severely limiting movement) Presence of neurological problems (uncontrolled epilepsy or neurodegenerative diseases such as Parkinson’s disease or multiple sclerosis) Severe visual or hearing impairment and inability to communicate Renal failure Need for emergency surgery Duration of cardiac surgery more than 6 hours Low level of consciousness (GCS <15) 24 hours after surgery Mechanical ventilation lasting more than 24 hours T82 Complications of cardiac and vascular prosthetic devices, implants and grafts Rehabilitation Rehabilitation Intervention group: Patients in the intervention group, in addition to receiving standard hospital care and routine physiotherapy (including respiratory physiotherapy, limb physiotherapy, incentive spirometry, and use of a vibrator), will participate in an early mobilization program twice daily (morning and evening) from 24 hours after surgery until discharge. On the first day, patients will perform passive range of motion exercises for both upper and lower limbs (8–10 repetitions for each movement) and will sit on the bed for 15 minutes during each session. On the second day, patients will perform active range of motion exercises and sit at the edge of the bed with legs dangling for 10 minutes during each session. On the third day, in addition to the previous activities, after disconnecting monitoring lines and clamping the drains, patients—while being monitored with a portable pulse oximeter and supported by the researcher—will sit on a chair beside the bed for 15 minutes, and if their heart rate and respiratory status are stable, they will walk 20–50 meters beside the bed. On the fourth day, under similar conditions, patients will walk 50–100 meters with the researcher’s support. On the fifth day, patients will walk 100–200 meters independently under the researcher’s supervision and will also climb 3–5 stairs with support. From the sixth day until discharge, patients will, according to their tolerance, increase the walking distance and the number of stairs climbed during each session. Each intervention session will last an average of 30 minutes. Before starting each session, vital signs and pain level will be assessed using the Visual Analogue Scale (VAS) and recorded in the daily intervention checklist. If the patient reports a pain intensity of 4 or higher on the VAS, the researcher will request an analgesic prescription from the physician. After the medication is administered, a waiting period corresponding to the onset of action or, if necessary, half-life duration (based on the pharmacological characteristics of the drug) will be observed. Subsequently, the pain intensity will be reassessed, and if it decreases to below 4, the exercise session will begin. The type, dosage, and frequency of analgesic use, along with the reported pain intensity, will be documented for comparison between groups. The exercise intensity during all sessions will be maintained between 11 and 13 on the Borg Rating of Perceived Exertion (RPE) scale (6–20), corresponding to a light to somewhat hard level of effort. During mobilization out of bed, patients will be monitored using a portable pulse oximeter. If the heart rate increases by more than 20% from baseline or if the oxygen saturation (SpO₂) drops below 90%, the intervention will be terminated for that session. Control group: Patients in the control group will receive standard hospital care and routine physiotherapy (including respiratory physiotherapy, limb physiotherapy, incentive spirometry, and the use of a vibrator) once daily from the first working day after surgery until hospital discharge. During their stay in the ICU-OH, these patients will not receive any structured or systematic exercise program for gradual mobilization, and getting out of bed will begin only after their transfer to the ward. Functional capacity. Timepoint: ChatGPT said:The assessment of functional capacity will be performed in the first stage one day before surgery, prior to the start of the intervention, and in the second stage on the day of hospital discharge. Method of measurement: 6-minute walk test. Kinesiophobia. Timepoint: The level of kinesiophobia will be assessed at four time points: 24 hours after surgery (before the start of the intervention), on the third and fifth postoperative days, and on the day of hospital discharge. Method of measurement: Kinesiophobia will be assessed using the Tampa Scale for Kinesiophobia (TSK). Quality of recovery. Timepoint: The quality of recovery will be assessed at two time points: 24 hours after surgery (before the start of the intervention) and on the day of hospital discharge. Method of measurement: The quality of recovery will be assessed using the 40-item Quality of Recovery questionnaire (QoR-40). Mazandaran University of Medical Sciences Approved 2025-10-29 Ethics Committee of Mazandaran University of Medical Sciences Building No. 2, Vice Chancellor for Research, Mazandaran University of Medical Sciences, Moallem Square Sari Mazandaran Iran (Islamic Republic of)