Aortic Valve Disease, Coronary Artery Disease, Mitral Valve Disease
Conditions
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.
Interventions
PROCEDUREIntensive early mobilization techniques
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.
Sponsors
University of Macedonia, Thessaloniki, Greece
Dimitris Chatzitheodorou
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Patients and outcomes assessor will be blinded to the protocol each patient will be treated with. Both intervention and standard care protocols will be implemented by a third party.
Intervention model description
Prospective randomized controlled double-blind 2-group experimental design.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital mortality | Up to 6 weeks | The number of postsurgical hospital deaths. |
Countries
Greece
Outcome results
None listed