Effect of Early Mobilization on Length of Stay, Recovery and Readmission Rate of Patients After CABG or AVR/MVR Surgery
NCT ID: NCT04401397
Last Updated: 2021-01-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2020-06-03
2020-12-23
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* No previous CABG or valve surgery
* Isolated / multivessel CABG
Exclusion Criteria
* Previous cerebral vascular accident with residual neurological deficit significant enough to limit exercise
* Significant limiting comorbidities that would prevent full participation
18 Years
ALL
No
Sponsors
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University of Macedonia, Thessaloniki, Greece
OTHER
Dimitris Chatzitheodorou
OTHER
Responsible Party
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Dimitris Chatzitheodorou
Principal Investigator, Senior Physical Therapist
Locations
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Papageorgiou General Hospital
Thessaloniki, Pavlou Mela Municipality, Greece
Countries
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References
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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.
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.
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.
Adler J, Malone D. Early mobilization in the intensive care unit: a systematic review. Cardiopulm Phys Ther J. 2012 Mar;23(1):5-13.
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.
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.
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.
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, 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.
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.
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.
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.
Other Identifiers
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PapageorgiouGH
Identifier Type: -
Identifier Source: org_study_id
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