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

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.

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Aortic Valve Disease; Mitral Valve Disease
• Intervention / Treatment: Procedure: Intensive early mobilization techniques

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Pavlou Mela Municipality
    • Thessaloníki, Pavlou Mela Municipality, Greece, 56403
      • Papageorgiou General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early mobilization group; 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.	Procedure: Intensive 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.
Active Comparator: Standard care group; 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.	Procedure: Intensive 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital mortality	The number of postsurgical hospital deaths.	Up to 6 weeks

Collaborators and Investigators

• Sponsor: Dimitris Chatzitheodorou
• Collaborators: University of Macedonia, Thessaloniki, Greece

Publications and helpful links

General Publications

• Bailey P, Thomsen GE, Spuhler VJ, Blair R, Jewkes J, Bezdjian L, Veale K, Rodriquez L, Hopkins RO. Early activity is feasible and safe in respiratory failure patients. Crit Care Med. 2007 Jan;35(1):139-45. doi: 10.1097/01.CCM.0000251130.69568.87.
• Morris PE, Goad A, Thompson C, Taylor K, Harry B, Passmore L, Ross A, Anderson L, Baker S, Sanchez M, Penley L, Howard A, Dixon L, Leach S, Small R, Hite RD, Haponik E. Early intensive care unit mobility therapy in the treatment of acute respiratory failure. Crit Care Med. 2008 Aug;36(8):2238-43. doi: 10.1097/CCM.0b013e318180b90e.
• Schweickert WD, Pohlman MC, Pohlman AS, Nigos C, Pawlik AJ, Esbrook CL, Spears L, Miller M, Franczyk M, Deprizio D, Schmidt GA, Bowman A, Barr R, McCallister KE, Hall JB, Kress JP. Early physical and occupational therapy in mechanically ventilated, critically ill patients: a randomised controlled trial. Lancet. 2009 May 30;373(9678):1874-82. doi: 10.1016/S0140-6736(09)60658-9. Epub 2009 May 14.
• Morris PE, Griffin L, Berry M, Thompson C, Hite RD, Winkelman C, Hopkins RO, Ross A, Dixon L, Leach S, Haponik E. Receiving early mobility during an intensive care unit admission is a predictor of improved outcomes in acute respiratory failure. Am J Med Sci. 2011 May;341(5):373-7. doi: 10.1097/MAJ.0b013e31820ab4f6.
• Brummel NE, Girard TD, Ely EW, Pandharipande PP, Morandi A, Hughes CG, Graves AJ, Shintani A, Murphy E, Work B, Pun BT, Boehm L, Gill TM, Dittus RS, Jackson JC. Feasibility and safety of early combined cognitive and physical therapy for critically ill medical and surgical patients: the Activity and Cognitive Therapy in ICU (ACT-ICU) trial. Intensive Care Med. 2014 Mar;40(3):370-9. doi: 10.1007/s00134-013-3136-0. Epub 2013 Nov 21.
• Needham DM, Korupolu R, Zanni JM, Pradhan P, Colantuoni E, Palmer JB, Brower RG, Fan E. Early physical medicine and rehabilitation for patients with acute respiratory failure: a quality improvement project. Arch Phys Med Rehabil. 2010 Apr;91(4):536-42. doi: 10.1016/j.apmr.2010.01.002.
• Gosselink R, Bott J, Johnson M, Dean E, Nava S, Norrenberg M, Schonhofer B, Stiller K, van de Leur H, Vincent JL. Physiotherapy for adult patients with critical illness: recommendations of the European Respiratory Society and European Society of Intensive Care Medicine Task Force on Physiotherapy for Critically Ill Patients. Intensive Care Med. 2008 Jul;34(7):1188-99. doi: 10.1007/s00134-008-1026-7. Epub 2008 Feb 19.
• Adler J, Malone D. Early mobilization in the intensive care unit: a systematic review. Cardiopulm Phys Ther J. 2012 Mar;23(1):5-13.
• Chiarici A, Andrenelli E, Serpilli O, Andreolini M, Tedesco S, Pomponio G, Gallo MM, Martini C, Papa R, Coccia M, Ceravolo MG. An Early Tailored Approach Is the Key to Effective Rehabilitation in the Intensive Care Unit. Arch Phys Med Rehabil. 2019 Aug;100(8):1506-1514. doi: 10.1016/j.apmr.2019.01.015. Epub 2019 Feb 21.
• Corcoran JR, Herbsman JM, Bushnik T, Van Lew S, Stolfi A, Parkin K, McKenzie A, Hall GW, Joseph W, Whiteson J, Flanagan SR. Early Rehabilitation in the Medical and Surgical Intensive Care Units for Patients With and Without Mechanical Ventilation: An Interprofessional Performance Improvement Project. PM R. 2017 Feb;9(2):113-119. doi: 10.1016/j.pmrj.2016.06.015. Epub 2016 Jun 23.
• Lord RK, Mayhew CR, Korupolu R, Mantheiy EC, Friedman MA, Palmer JB, Needham DM. ICU early physical rehabilitation programs: financial modeling of cost savings. Crit Care Med. 2013 Mar;41(3):717-24. doi: 10.1097/CCM.0b013e3182711de2.
• Tsuboi N, Hiratsuka M, Kaneko S, Nishimura N, Nakagawa S, Kasahara M, Kamikubo T. Benefits of Early Mobilization After Pediatric Liver Transplantation. Pediatr Crit Care Med. 2019 Feb;20(2):e91-e97. doi: 10.1097/PCC.0000000000001815.
• van Willigen Z, Collings N, Richardson D, Cusack R. Quality improvement: The delivery of true early mobilisation in an intensive care unit. BMJ Qual Improv Rep. 2016 Dec 30;5(1):u211734.w4726. doi: 10.1136/bmjquality.u211734.w4726. eCollection 2016.
• Li Z, Peng X, Zhu B, Zhang Y, Xi X. Active mobilization for mechanically ventilated patients: a systematic review. Arch Phys Med Rehabil. 2013 Mar;94(3):551-61. doi: 10.1016/j.apmr.2012.10.023. Epub 2012 Nov 2.
• Parker A, Sricharoenchai T, Needham DM. Early Rehabilitation in the Intensive Care Unit: Preventing Physical and Mental Health Impairments. Curr Phys Med Rehabil Rep. 2013 Dec;1(4):307-314. doi: 10.1007/s40141-013-0027-9.
• Mendez-Tellez PA, Nusr R, Feldman D, Needham DM. Early Physical Rehabilitation in the ICU: A Review for the Neurohospitalist. Neurohospitalist. 2012 Jul;2(3):96-105. doi: 10.1177/1941874412447631.
• Hopkins RO, Spuhler VJ, Thomsen GE. Transforming ICU culture to facilitate early mobility. Crit Care Clin. 2007 Jan;23(1):81-96. doi: 10.1016/j.ccc.2006.11.004.

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2020
• Primary Completion (Actual): December 10, 2020
• Study Completion (Actual): December 23, 2020

Study Registration Dates

• First Submitted: May 15, 2020
• First Submitted That Met QC Criteria: May 20, 2020
• First Posted (Actual): May 26, 2020

Study Record Updates

• Last Update Posted (Actual): January 5, 2021
• Last Update Submitted That Met QC Criteria: January 3, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Valve Diseases; Coronary Disease; Coronary Artery Disease; Aortic Valve Disease
• Other Study ID Numbers: PapageorgiouGH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No