Effect of Early Mobilization on Length of Stay, Recovery and Readmission Rate of Patients After CABG or AVR/MVR Surgery

Study Overview
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Brief Summary
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The present study will investigate the volume and extent of the expected physiological effects of early mobilization on the prevention of the clinical illness' detrimental sequelae and on the functional recovery promotion of CABG, AVR and MVR patients. Consequently, it will investigate if the improved health outcomes may limit the number and intensity of complications and thus if it may speed up hospital discharge.

Detailed Description
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Although the effects of early mobilization have been studied mainly in the intensive care unit setting, the findings could be applied to the surgical units' patients too, since they share common physiological and clinical characteristics. In the literature the effectiveness of early mobilization in the length of hospital stay and recovery of the patients operated for coronary artery bypass graft and heart valve replacement in the cardiac surgery setting, is unknown. The term early mobilization is not restricted to a time factor procedure but contains the provision of a customized dynamic set of physical therapy techniques which in studies are variably determined in terms of duration, intensity, frequency and content. The aim of the study is to determine the clinical effectiveness of the intensive early mobilization physical therapy intervention compared with standard care of physical therapy in the cardio-thoracic surgery clinic of Papageorgiou General Hospital of Thessaloniki. The present study will investigate the volume and extend of the expected physiological effects of early mobilization on the prevention of the clinical illness' detrimental sequelae and on the functional recovery promotion, hospital mortality and readmission rate of CABG, AVR and MVR patients. Consequently, it will investigate if the improved health outcomes may limit the number and intensity of complications and thus may speed up hospital discharge. In the first group of the experimental design, patients will be treated with an intensive early mobilization protocol and the patients of the second group will receive a standard care physical therapy treatment. Controlling for the detailed baseline characteristics that will be assessed during medical history at admission, potential bias will be limited from unmeasured confounders of the study.

Official Title
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The Effect of Inpatient Intensive Early Mobilisation Intervention on Length of Hospital Stay, Medical and Functional Recovery and Readmission Rate of Patients After CABG or AVR/MVR: A Randomized Single Blind Controlled Clinical Trial.

Conditions
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Coronary Artery Disease, Aortic Valve Disease, Mitral Valve Disease

Intervention / Treatment
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* Procedure: Intensive early mobilization techniques


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Elective CABG or AVR or MVR surgery No previous CABG or valve surgery Isolated / multivessel CABG Exclusion Criteria: Current neurological disorders Previous cerebral vascular accident with residual neurological deficit significant enough to limit exercise Significant limiting comorbidities that would prevent full participation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: Prospective randomized controlled double-blind 2-group experimental design.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early mobilization group<br>Immediately after ICU extubation, enrolled patients will receive an intensive 30-45 minutes, implemented twice a day early mobilization protocol containing psychological empowerment, detailed informative education of patients and close relatives, close monitoring of the recovery course, frequent parameter protocol configuration, high intensity active progressive pulmonary and musculoskeletal exercises and mobility techniques, close monitoring for early identification and measures for prevention and treatment of complications. | Procedure: Intensive early mobilization techniques<br>* Pulmonary techniques: lung mechanics and breathing pattern restoration, mucus clearance techniques, breathing control and cough techniques. Musculoskeletal techniques: strengthening and functional exercises, active assistive moving techniques.<br>|
| Active Comparator: Standard care group<br>Enrolled patients will receive the standard hospital mobilization protocol after their admission to the ward, containing standardized basic pulmonary and mobilization techniques of 15 minutes, once a day. | Procedure: Intensive early mobilization techniques<br>* Pulmonary techniques: lung mechanics and breathing pattern restoration, mucus clearance techniques, breathing control and cough techniques. Musculoskeletal techniques: strengthening and functional exercises, active assistive moving techniques.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of postoperative hospital stay | The number of postoperative days that the patients stay in the ward after their surgery procedure and ICU discharge. | Up to 6 weeks | 
| Readmission rate | The number of discharged patients that will be readmitted in the hospital for a condition of their underlying disease in a 30 days period after surgery. | Up to 6 weeks | 
| Number of complications | The total number of medical events the patients will develop during their postoperative stay in the ward. | Up to 6 weeks | 
| Severity of complications | Classification of the complications as minor or major according to the physicians' expert opinion based on published clinical standards. | Up to 6 weeks | 
| Time to regain hemodynamic stability | The time in days that is required for the patients to be without inotrope or vasodilator drugs and remain normal and stable in arterial blood pressure, heart rate and blood gas rates. | Up to 6 weeks | 
| Two-minute walk test | The distance in meters that a patient can walk under the specific test conditions, at the day of discharge. | Up to 6 weeks | 
| Functional recovery | The time in days that is required for the patients to be autonomous in accessing and using the toilet in their ward. | Up to 6 weeks | 
| High cost medical procedures | The number of high cost medical procedures the patients will undergo during their postoperative stay in the ward. | Up to 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital mortality | The number of postsurgical hospital deaths. | Up to 6 weeks |