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

Dimitris Chatzitheodorou

Status: Completed

Conditions: Mitral Valve Disease; Coronary Artery Disease; Aortic Valve Disease

Treatments: Procedure: Intensive early mobilization techniques

Study type: Interventional

Funder types: Other

Identifiers

NCT04401397

PapageorgiouGH

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Early mobilization group

Experimental group

Description:

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.

Treatment:

Procedure: Intensive early mobilization techniques

Standard care group

Active Comparator group

Description:

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.

Treatment:

Procedure: Intensive early mobilization techniques