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

Not Applicable

Completed

• Conditions: Coronary Artery Disease; Mitral Valve Disease; Aortic Valve Disease
• Interventions: Procedure: Intensive early mobilization techniques

• Registration Number: NCT04401397
• Lead Sponsor: Dimitris Chatzitheodorou

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2020-05-15
• Study First Submitted QC: 2020-05-20
• Study First Posted: 2020-05-26
• Study Start: 2020-06-03
• Primary Completion: 2020-12-10
• Study Completion: 2020-12-23
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-03
• Last Update Posted: 2021-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Early mobilization group	Intensive early mobilization techniques	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.
Standard care group	Intensive early mobilization techniques	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.

Primary Outcome Measures

Name	Time	Method
Length of postoperative hospital stay	Up to 6 weeks	The number of postoperative days that the patients stay in the ward after their surgery procedure and ICU discharge.
Number of complications	Up to 6 weeks	The total number of medical events the patients will develop during their postoperative stay in the ward.
Severity of complications	Up to 6 weeks	Classification of the complications as "minor" or "major" according to the physicians' expert opinion based on published clinical standards.
High cost medical procedures	Up to 6 weeks	The number of high cost medical procedures the patients will undergo during their postoperative stay in the ward.
Readmission rate	Up to 6 weeks	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.
Two-minute walk test	Up to 6 weeks	The distance in meters that a patient can walk under the specific test conditions, at the day of discharge.
Functional recovery	Up to 6 weeks	The time in days that is required for the patients to be autonomous in accessing and using the toilet in their ward.
Time to regain hemodynamic stability	Up to 6 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Hospital mortality	Up to 6 weeks	The number of postsurgical hospital deaths.

Trial Locations

Locations (1)

Papageorgiou General Hospital; 🇬🇷 Thessaloníki, Pavlou Mela Municipality, Greece