Clinical trial NCT04401397: Effect of Early Mobilization on Length of Stay, Recovery and Readmission Rate of Patients After CABG or AVR/MVR Surgery
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Aortic Valve Disease
Mitral Valve Disease
Lead sponsor: Papageorgiou General Hospital
Sponsor class: OTHER
Collaborators: name: University of Macedonia, Thessaloniki, Greece
First posted: 2020-05-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Prospective randomized controlled double-blind 2-group experimental design.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Length of postoperative hospital stay
timeFrame: Up to 6 weeks
measure: Readmission rate
timeFrame: Up to 6 weeks
measure: Number of complications
timeFrame: Up to 6 weeks
measure: Severity of complications
timeFrame: Up to 6 weeks
measure: Time to regain hemodynamic stability
timeFrame: Up to 6 weeks
measure: Two-minute walk test
timeFrame: Up to 6 weeks
measure: Functional recovery
timeFrame: Up to 6 weeks
measure: High cost medical procedures
timeFrame: Up to 6 weeks
Secondary outcomes:
measure: Hospital mortality
timeFrame: Up to 6 weeks
Other outcomes:
Locations:
city: Thessaloníki
country: Greece
facility: Papageorgiou General Hospital
state: Pavlou Mela Municipality
Study officials:
References:
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