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

Primary Purpose

Coronary Artery Disease, Aortic Valve Disease, Mitral Valve Disease

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Intensive early mobilization techniques
Sponsored by
Dimitris Chatzitheodorou
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Coronary Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Papageorgiou General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Early mobilization group

Standard care group

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Hospital mortality
The number of postsurgical hospital deaths.

Full Information

First Posted
May 15, 2020
Last Updated
January 3, 2021
Sponsor
Dimitris Chatzitheodorou
Collaborators
University of Macedonia, Thessaloniki, Greece
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1. Study Identification

Unique Protocol Identification Number
NCT04401397
Brief Title
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

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
June 3, 2020 (Actual)
Primary Completion Date
December 10, 2020 (Actual)
Study Completion Date
December 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dimitris Chatzitheodorou
Collaborators
University of Macedonia, Thessaloniki, Greece

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Aortic Valve Disease, Mitral Valve Disease

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Prospective randomized controlled double-blind 2-group experimental design.
Masking
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early mobilization group
Arm Type
Experimental
Arm 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.
Arm Title
Standard care group
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Intensive early mobilization techniques
Intervention Description
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.
Primary Outcome Measure Information:
Title
Length of postoperative hospital stay
Description
The number of postoperative days that the patients stay in the ward after their surgery procedure and ICU discharge.
Time Frame
Up to 6 weeks
Title
Readmission rate
Description
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.
Time Frame
Up to 6 weeks
Title
Number of complications
Description
The total number of medical events the patients will develop during their postoperative stay in the ward.
Time Frame
Up to 6 weeks
Title
Severity of complications
Description
Classification of the complications as "minor" or "major" according to the physicians' expert opinion based on published clinical standards.
Time Frame
Up to 6 weeks
Title
Time to regain hemodynamic stability
Description
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.
Time Frame
Up to 6 weeks
Title
Two-minute walk test
Description
The distance in meters that a patient can walk under the specific test conditions, at the day of discharge.
Time Frame
Up to 6 weeks
Title
Functional recovery
Description
The time in days that is required for the patients to be autonomous in accessing and using the toilet in their ward.
Time Frame
Up to 6 weeks
Title
High cost medical procedures
Description
The number of high cost medical procedures the patients will undergo during their postoperative stay in the ward.
Time Frame
Up to 6 weeks
Secondary Outcome Measure Information:
Title
Hospital mortality
Description
The number of postsurgical hospital deaths.
Time Frame
Up to 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Papageorgiou General Hospital
City
Thessaloníki
State/Province
Pavlou Mela Municipality
ZIP/Postal Code
56403
Country
Greece

12. IPD Sharing Statement

Plan to Share IPD
No
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Effect of Early Mobilization on Length of Stay, Recovery and Readmission Rate of Patients After CABG or AVR/MVR Surgery

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