Improving physical function of patients following intensive care unit admission (EMPRESS): protocol of a randomised controlled feasibility trial

Rebecca Cusack, Andrew Bates, Kay Mitchell, Zoe van Willigen, Linda Denehy, Nicholas Hart, Ahilanandan Dushianthan, Isabel Reading, Maria Chorozoglou, Gordon Sturmey, Iain Davey, Michael Grocott, Rebecca Cusack, Andrew Bates, Kay Mitchell, Zoe van Willigen, Linda Denehy, Nicholas Hart, Ahilanandan Dushianthan, Isabel Reading, Maria Chorozoglou, Gordon Sturmey, Iain Davey, Michael Grocott

Abstract

Introduction: Physical rehabilitation delivered early following admission to the intensive care unit (ICU) has the potential to improve short-term and long-term outcomes. The use of supine cycling together with other rehabilitation techniques has potential as a method of introducing rehabilitation earlier in the patient journey. The aim of the study is to determine the feasibility of delivering the designed protocol of a randomised clinical trial comparing a protocolised early rehabilitation programme including cycling with usual care. This feasibility study will inform a larger multicentre study.

Methods and analysis: 90 acute care medical patients from two mixed medical-surgical ICUs will be recruited. We will include ventilated patients within 72 hours of initiation of mechanical ventilation and expected to be ventilated a further 48 hours or more. Patients will receive usual care or usual care plus two 30 min rehabilitation sessions 5 days/week.Feasibility outcomes are (1) recruitment of one to two patients per month per site; (2) protocol fidelity with >75% of patients commencing interventions within 72 hours of mechanical ventilation, with >70% interventions delivered; and (3) blinded outcome measures recorded at three time points in >80% of patients. Secondary outcomes are (1) strength and function, the Physical Function ICU Test-scored measured on ICU discharge; (2) hospital length of stay; and (3) mental health and physical ability at 3 months using the WHO Disability Assessment Schedule 2. An economic analysis using hospital health services data reported with an embedded health economic study will collect and assess economic and quality of life data including the Hospital Anxiety and Depression Scales core, the Euroqol-5 Dimension-5 Level and the Impact of Event Score.

Ethics and dissemination: The study has ethical approval from the South Central Hampshire A Research Ethics Committee (19/SC/0016). All amendments will be approved by this committee. An independent trial monitoring committee is overseeing the study. Results will be made available to critical care survivors, their caregivers, the critical care societies and other researchers.

Trial registration number: NCT03771014.

Keywords: Critical care; cycling; physical therapy; rehabilitation.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.

Figures

Figure 1
Figure 1
Study design. CFS, Clinical Frailty Score; CPAx, Chelsea Critical Care Physical Assessment Tool; EQ-5D-5L, Euroqol-5 Dimension-5 Level; HAD, ICU, intensive care unit; IES, Impact of Event Score; WHODAS 2.0, WHO Disability Assessment Schedule 2.
Figure 2
Figure 2
Consent pathway.
Figure 3
Figure 3
Study intervention pathway. (PROM = Passive Range of Movement)

References

    1. Hospital Admitted Patient Care Activity 2018-19 . NHS England; 2019 [National stastics]. Available: [Accessed Acessed 21st Aug 2021].
    1. Esteban A, Frutos-Vivar F, Muriel A, et al. . Evolution of mortality over time in patients receiving mechanical ventilation. Am J Respir Crit Care Med 2013;188:220–30. 10.1164/rccm.201212-2169OC
    1. Kaukonen K-M, Bailey M, Suzuki S, et al. . Mortality related to severe sepsis and septic shock among critically ill patients in Australia and New Zealand, 2000-2012. JAMA 2014;311:1308–16. 10.1001/jama.2014.2637
    1. Iwashyna TJ, Netzer G. The burdens of survivorship: an approach to thinking about long-term outcomes after critical illness. Semin Respir Crit Care Med 2012;33:327–38. 10.1055/s-0032-1321982
    1. Cheung AM, Tansey CM, Tomlinson G, et al. . Two-Year outcomes, health care use, and costs of survivors of acute respiratory distress syndrome. Am J Respir Crit Care Med 2006;174:538–44. 10.1164/rccm.200505-693OC
    1. Cuthbertson BH, Roughton S, Jenkinson D, et al. . Quality of life in the five years after intensive care: a cohort study. Critical Care 2010;14:R6. 10.1186/cc8848
    1. Desai SV, Law TJ, Needham DM. Long-Term complications of critical care. Crit Care Med 2011;39:371–9. 10.1097/CCM.0b013e3181fd66e5
    1. Griffiths J, Hatch RA, Bishop J, et al. . An exploration of social and economic outcome and associated health-related quality of life after critical illness in general intensive care unit survivors: a 12-month follow-up study. Critical Care 2013;17:R100. 10.1186/cc12745
    1. Herridge MS, Tansey CM, Matté A, et al. . Functional disability 5 years after acute respiratory distress syndrome. N Engl J Med 2011;364:1293–304. 10.1056/NEJMoa1011802
    1. Iwashyna TJ, Ely EW, Smith DM, et al. . Long-Term cognitive impairment and functional disability among survivors of severe sepsis. JAMA 2010;304:1787–94. 10.1001/jama.2010.1553
    1. Lone NI, Gillies MA, Haddow C, et al. . Five-Year mortality and hospital costs associated with surviving intensive care. Am J Respir Crit Care Med 2016;194:198–208. 10.1164/rccm.201511-2234OC
    1. Allen C, Glasziou P, Del Mar C. Bed rest: a potentially harmful treatment needing more careful evaluation. Lancet 1999;354:1229–33. 10.1016/S0140-6736(98)10063-6
    1. Jolley SE, Bunnell AE, Hough CL. ICU-Acquired weakness. Chest 2016;150:1129–40. 10.1016/j.chest.2016.03.045
    1. Parry SM, Puthucheary ZA. The impact of extended bed rest on the musculoskeletal system in the critical care environment. Extrem Physiol Med 2015;4:16. 10.1186/s13728-015-0036-7
    1. Puthucheary ZA, Rawal J, McPhail M, et al. . Acute skeletal muscle wasting in critical illness. JAMA 2013;310:1591–600. 10.1001/jama.2013.278481
    1. Levine S, Nguyen T, Taylor N, et al. . Rapid disuse atrophy of diaphragm fibers in mechanically ventilated humans. N Engl J Med 2008;358:1327–35. 10.1056/NEJMoa070447
    1. Needham DM. Mobilizing patients in the intensive care unit: improving neuromuscular weakness and physical function. JAMA 2008;300:1685–90. 10.1001/jama.300.14.1685
    1. Kress JP, Hall JB. Critical care medicine ICU-Acquired weakness and recovery from critical illness. NEJM 2014;370:1626–35.
    1. Hodgson CL, Berney S, Harrold M, et al. . Clinical review: early patient mobilization in the ICU. Crit Care 2012;17:207. 10.1186/cc11820
    1. Schweickert WD, Pohlman MC, Pohlman AS, et al. . Early physical and occupational therapy in mechanically ventilated, critically ill patients: a randomised controlled trial. The Lancet 2009;373:1874–82. 10.1016/S0140-6736(09)60658-9
    1. Schujmann DS, Teixeira Gomes T, Lunardi AC, et al. . Impact of a progressive mobility program on the functional status, respiratory, and muscular systems of ICU patients: a randomized and controlled trial. Crit Care Med 2020;48:491–7. 10.1097/CCM.0000000000004181
    1. Calvo-Ayala E, Khan BA, Farber MO, et al. . Interventions to improve the physical function of ICU survivors: a systematic review. Chest 2013;144:1469–80. 10.1378/chest.13-0779
    1. Waldauf P, Jiroutková K, Krajčová A, et al. . Effects of rehabilitation interventions on clinical outcomes in critically ill patients: systematic review and meta-analysis of randomized controlled trials. Crit Care Med 2020;48:1055–65. 10.1097/CCM.0000000000004382
    1. Kayambu G, Boots R, Paratz J. Physical therapy for the critically ill in the ICU: a systematic review and meta-analysis. Crit Care Med 2013;41:1543–54. 10.1097/CCM.0b013e31827ca637
    1. Berney SC, Harrold M, Webb SA, et al. . Intensive care unit mobility practices in Australia and New Zealand: a point prevalence study. Crit Care Resusc 2013;15:260–5.
    1. Harrold ME, Salisbury LG, Webb SA, et al. . Early mobilisation in intensive care units in Australia and Scotland: a prospective, observational cohort study examining mobilisation practises and barriers. Crit Care 2015;19:336. 10.1186/s13054-015-1033-3
    1. Nydahl P, Ruhl AP, Bartoszek G, et al. . Early mobilization of mechanically ventilated patients: a 1-day point-prevalence study in Germany. Crit Care Med 2014;42:1178–86. 10.1097/CCM.0000000000000149
    1. McWilliams D, Jones C, Atkins G, et al. . Earlier and enhanced rehabilitation of mechanically ventilated patients in critical care: a feasibility randomised controlled trial. J Crit Care 2018;44:407–12. 10.1016/j.jcrc.2018.01.001
    1. Wright SE, Thomas K, Watson G, et al. . Intensive versus standard physical rehabilitation therapy in the critically ill (EPICC): a multicentre, parallel-group, randomised controlled trial. Thorax 2018;73:213–21. 10.1136/thoraxjnl-2016-209858
    1. Denehy L, Skinner EH, Edbrooke L, et al. . Exercise rehabilitation for patients with critical illness: a randomized controlled trial with 12 months of follow-up. Critical Care 2013;17:R156. 10.1186/cc12835
    1. Moss M, Nordon-Craft A, Malone D, et al. . A randomized trial of an intensive physical therapy program for patients with acute respiratory failure. Am J Respir Crit Care Med 2016;193:1101–10. 10.1164/rccm.201505-1039OC
    1. Walsh TS, Salisbury LG, Boyd J, et al. . A randomised controlled trial evaluating a rehabilitation complex intervention for patients following intensive care discharge: the recover study. BMJ Open 2012;2:e001475. 10.1136/bmjopen-2012-001475
    1. Cuthbertson BH, Rattray J, Campbell MK, et al. . The practical study of nurse led, intensive care follow-up programmes for improving long term outcomes from critical illness: a pragmatic randomised controlled trial. BMJ 2009;339:b3723–b23. 10.1136/bmj.b3723
    1. Elliott D, McKinley S, Alison J, et al. . Health-Related quality of life and physical recovery after a critical illness: a multi-centre randomised controlled trial of a home-based physical rehabilitation program. Crit Care 2011;15:R142. 10.1186/cc10265
    1. Dubb R, Nydahl P, Hermes C, et al. . Barriers and strategies for early mobilization of patients in intensive care units. Ann Am Thorac Soc 2016;13:724–30. 10.1513/AnnalsATS.201509-586CME
    1. Nydahl P, Sricharoenchai T, Chandra S, et al. . Safety of patient mobilization and rehabilitation in the intensive care unit. systematic review with meta-analysis. Ann Am Thorac Soc 2017;14:766–77. 10.1513/AnnalsATS.201611-843SR
    1. Kho ME, Martin RA, Toonstra AL, et al. . Feasibility and safety of in-bed cycling for physical rehabilitation in the intensive care unit. J Crit Care 2015;30:1419.e1–1419.e5. 10.1016/j.jcrc.2015.07.025
    1. Sricharoenchai T, Parker AM, Zanni JM, et al. . Safety of physical therapy interventions in critically ill patients: a single-center prospective evaluation of 1110 intensive care unit admissions. J Crit Care 2014;29:395–400. 10.1016/j.jcrc.2013.12.012
    1. Kho ME, Molloy AJ, Clarke FJ, et al. . TryCYCLE: a prospective study of the safety and feasibility of early In-Bed cycling in mechanically ventilated patients. PLoS One 2016;11:e0167561. 10.1371/journal.pone.0167561
    1. Camargo Pires-Neto R, Fogaça Kawaguchi YM, Sayuri Hirota A, et al. . Very early passive cycling exercise in mechanically ventilated critically ill patients: physiological and safety aspects--a case series. PLoS One 2013;8:e74182. 10.1371/journal.pone.0074182
    1. Wilkinson OM, Bates A, Cusack R. An observational feasibility study - does early limb ergometry affect oxygen delivery and uptake in intubated critically ill patients – a comparison of two assessment methods. BMC Anesthesiol 2021;21:27. 10.1186/s12871-020-01227-z
    1. Hickmann CE, Castanares-Zapatero D, Deldicque L, et al. . Impact of very early physical therapy during septic shock on skeletal muscle: a randomized controlled trial. Crit Care Med 2018;46:1436–43. 10.1097/CCM.0000000000003263
    1. Machado ADS, Pires-Neto RC, Carvalho MTX, et al. . Effects that passive cycling exercise have on muscle strength, duration of mechanical ventilation, and length of hospital stay in critically ill patients: a randomized clinical trial. J Bras Pneumol 2017;43:134–9. 10.1590/s1806-37562016000000170
    1. Takaoka A, Utgikar R, Rochwerg B, et al. . The efficacy and safety of In-Intensive care unit Leg-Cycle Ergometry in critically ill adults. A systematic review and meta-analysis. Ann Am Thorac Soc 2020;17:1289–307. 10.1513/AnnalsATS.202001-059OC
    1. van Willigen Z, Collings N, Richardson D, et al. . Quality improvement: the delivery of true early mobilisation in an intensive care unit. BMJ Qual Improv Rep 2016;5:u211734.w4726. 10.1136/bmjquality.u211734.w4726
    1. Needham DM, Korupolu R, Zanni JM, et al. . Early physical medicine and rehabilitation for patients with acute respiratory failure: a quality improvement project. Arch Phys Med Rehabil 2010;91:536–42. 10.1016/j.apmr.2010.01.002
    1. Morris PE, Goad A, Thompson C, et al. . Early intensive care unit mobility therapy in the treatment of acute respiratory failure. Crit Care Med 2008;36:2238–43. 10.1097/CCM.0b013e318180b90e
    1. McWilliams D, Weblin J, Atkins G, et al. . Enhancing rehabilitation of mechanically ventilated patients in the intensive care unit: a quality improvement project. J Crit Care 2015;30:13–18. 10.1016/j.jcrc.2014.09.018
    1. Lord RK, Mayhew CR, Korupolu R, et al. . Icu early physical rehabilitation programs: financial modeling of cost savings. Crit Care Med 2013;41:717–24. 10.1097/CCM.0b013e3182711de2
    1. Chan A-W, Tetzlaff JM, Altman DG, et al. . Spirit 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med 2013;158:200-+. 10.7326/0003-4819-158-3-201302050-00583
    1. Hoffmann TC, Glasziou PP, Boutron I, et al. . Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ 2014;348:g1687. 10.1136/bmj.g1687
    1. Act MC. Availble at 2005., 2005. Available: [Accessed 7 Dec 2021].
    1. Ely EW, Truman B, Shintani A, et al. . Monitoring sedation status over time in ICU patients: reliability and validity of the Richmond Agitation-Sedation scale (RASS). JAMA 2003;289:2983–91. 10.1001/jama.289.22.2983
    1. Sessler CN, Gosnell MS, Grap MJ, et al. . The Richmond Agitation–Sedation scale. Am J Respir Crit Care Med 2002;166:1338–44. 10.1164/rccm.2107138
    1. Ely EW, Inouye SK, Bernard GR. Delirium in mechanically ventilated patients - Validity and reliability of the Confusion Assessment Method for the intensive care unit (CAM-ICU). Jama-J Am Med Assoc 2001;286:2703–10.
    1. De Jonghe B, Sharshar T, Lefaucheur J-P, et al. . Paresis acquired in the intensive care unit: a prospective multicenter study. JAMA 2002;288:2859–67. 10.1001/jama.288.22.2859
    1. Denehy L, de Morton NA, Skinner EH, et al. . A physical function test for use in the intensive care unit: validity, responsiveness, and predictive utility of the physical function ICU test (scored). Phys Ther 2013;93:1636–45. 10.2522/ptj.20120310
    1. Skinner EH, Berney S, Warrillow S, et al. . Development of a physical function outcome measure (PFIT) and a pilot exercise training protocol for use in intensive care. Crit Care Resusc 2009;11:110–5.
    1. Fan E, Ciesla ND, Truong AD, et al. . Inter-Rater reliability of manual muscle strength testing in ICU survivors and simulated patients. Intensive Care Med 2010;36:1038–43. 10.1007/s00134-010-1796-6
    1. Hermans G, Clerckx B, Vanhullebusch T, et al. . Interobserver agreement of medical Research Council sum-score and handgrip strength in the intensive care unit. Muscle Nerve 2012;45:18–25. 10.1002/mus.22219
    1. Vanpee G, Segers J, Van Mechelen H, et al. . The interobserver agreement of handheld dynamometry for muscle strength assessment in critically ill patients. Crit Care Med 2011;39:1929–34. 10.1097/CCM.0b013e31821f050b
    1. Corner EJ, Wood H, Englebretsen C, et al. . The chelsea critical care physical assessment tool (CPAx): validation of an innovative new tool to measure physical morbidity in the general adult critical care population; an observational proof-of-concept pilot study. Physiotherapy 2013;99:33–41. 10.1016/j.physio.2012.01.003
    1. Hodgson C, Needham D, Haines K, et al. . Feasibility and inter-rater reliability of the ICU mobility scale. Heart Lung 2014;43:19–24. 10.1016/j.hrtlng.2013.11.003
    1. Bischoff HA, Stähelin HB, Monsch AU, et al. . Identifying a cut-off point for normal mobility: a comparison of the timed 'up and go' test in community-dwelling and institutionalised elderly women. Age Ageing 2003;32:315–20. 10.1093/ageing/32.3.315
    1. Ng SS, Hui-Chan CW. The timed up & go test: its reliability and association with lower-limb impairments and locomotor capacities in people with chronic stroke. Arch Phys Med Rehabil 2005;86:1641–7. 10.1016/j.apmr.2005.01.011
    1. Bagshaw M, Majumdar SR, Rolfson DB, et al. . A prospective multicenter cohort study of frailty in younger critically ill patients. Crit Care 2016;20:175. 10.1186/s13054-016-1338-x
    1. Bagshaw SM, Stelfox HT, Johnson JA, et al. . Long-Term association between frailty and health-related quality of life among survivors of critical illness: a prospective multicenter cohort study. Crit Care Med 2015;43:973–82. 10.1097/CCM.0000000000000860
    1. Rockwood K, Song X, MacKnight C, et al. . A global clinical measure of fitness and frailty in elderly people. CMAJ 2005;173:489–95. 10.1503/cmaj.050051
    1. statement ATS, ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories . Ats statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med 2002;166:111–7. 10.1164/ajrccm.166.1.at1102
    1. Ustun TB, Kostanjesek N, Chatterji S. Measuring health and disability : manual for WHO Disability Assessment Schedule (WHODAS 2.0) / edited by T.B. Üstün, N. Kostanjsek, S. Chatterji, J.Rehm. Geneva: World Health Organization, 2010.
    1. Bjelland I, Dahl AA, Haug TT, et al. . The validity of the hospital anxiety and depression scale. An updated literature review. J Psychosom Res 2002;52:69–77. 10.1016/s0022-3999(01)00296-3
    1. Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand 1983;67:361–70. 10.1111/j.1600-0447.1983.tb09716.x
    1. Herdman M, Gudex C, Lloyd A, et al. . Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res 2011;20:1727–36. 10.1007/s11136-011-9903-x
    1. Schwarzwald J, Solomon Z, Weisenberg M, et al. . Validation of the impact of event scale for psychological sequelae of combat. J Consult Clin Psychol 1987;55:251–6. 10.1037/0022-006X.55.2.251
    1. Proctor E, Silmere H, Raghavan R, et al. . Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health 2011;38:65–76. 10.1007/s10488-010-0319-7
    1. Eldridge SM, Chan CL, Campbell MJ, et al. . Consort 2010 statement: extension to randomised pilot and feasibility trials. BMJ 2016;355:i5239. 10.1136/bmj.i5239
    1. Sricharoenchai T, Parker AM, Zanni JM, et al. . Safety of physical therapy interventions in critically ill patients: a single-center prospective evaluation of 1110 intensive care unit admissions. J Crit Care 2014;29:395–400. 10.1016/j.jcrc.2013.12.012
    1. Kho ME, Molloy AJ, Clarke F, et al. . Cycle pilot: a protocol for a pilot randomised study of early cycle ergometry versus routine physiotherapy in mechanically ventilated patients. BMJ Open 2016;6:e011659. 10.1136/bmjopen-2016-011659
    1. Kayambu G, Boots RJ, Paratz JD. Early rehabilitation in sepsis: a prospective randomised controlled trial investigating functional and physiological outcomes The i-PERFORM Trial(Protocol Article). BMC Anesthesiol 2011;11:21. 10.1186/1471-2253-11-21
    1. Parry SM, Knight LD, Connolly B, et al. . Factors influencing physical activity and rehabilitation in survivors of critical illness: a systematic review of quantitative and qualitative studies. Intensive Care Med 2017;43:531–42. 10.1007/s00134-017-4685-4
    1. van Willigen Z, Gallagher L, Cusack R. New roles on ICU: the cost effectiveness of employing therapy technicians on intensive care to reduce length of stay and improve functional outcomes. Intens Care Med 2013;39:S488–S88.
    1. Skivington K, Matthews L, Simpson SA, et al. . A new framework for developing and evaluating complex interventions: update of medical Research Council guidance. BMJ;2021:n2061. 10.1136/bmj.n2061
    1. Blackwood B, Ringrow S, Clarke M, et al. . A core outcome set for critical care ventilation trials. Crit Care Med 2019;47:1324–31. 10.1097/CCM.0000000000003904

Source: PubMed

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

3
Abonnere