title: Extra Physiotherapy in Critical Care (EPICC) Trial Protocol: a randomised controlled trial of intensive versus standard physical rehabilitation therapy in the critically ill.
abstract: BACKGROUND
  Patients discharged from Critical Care suffer from excessive longer term morbidity and mortality. Physical and mental health measures of quality of life show a marked and immediate fall after admission to Critical Care with some recovery over time. However, physical function is still significantly reduced at 6 months. The National Institute for Health and Care Excellence clinical guideline on rehabilitation after critical illness, identified the need for high-quality randomised controlled trials to determine the most effective rehabilitation strategy for critically ill patients at risk of critical illness-associated physical morbidity. In response to this, we will conduct a randomised controlled trial, comparing physiotherapy aimed at early and intensive patient mobilisation with routine care. We hypothesise that this intervention will improve physical outcomes and the mental health and functional well-being of survivors of critical illness.
  
  
  METHODS
  308 adult patients who have received more than 48 h of non-invasive or invasive ventilation in Critical Care will be recruited to a patient-randomised, parallel group, controlled trial, comparing two intensities of physiotherapy. Participants will be randomised to receive either standard or intensive physiotherapy for the duration of their Critical Care admission. Outcomes will be recorded on Critical Care discharge, at 3 and 6 months following initial recruitment to the study. The primary outcome measure is physical health at 6 months, as measured by the SF-36 Physical Component Summary. Secondary outcomes include assessment of mental health, activities of daily living, delirium and ventilator-free days. We will also include a health economic analysis.
  
  
  BACKGROUND
  The trial has ethical approval from Newcastle and North Tyneside 2 Research Ethics Committee (11/NE/0206). There is a Trial Oversight Committee including an independent chair. The results of the study will be submitted for publication in peer-reviewed journals and presented at national and international scientific meetings.
  
  
  BACKGROUND
  ISRCTN20436833.
authors.affiliation: Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.
authors.forename: Kirsty
authors.identifier: http://orcid.org/0000-0002-3822-2050
authors.initials: K
authors.lastname: Thomas
authors.affiliation: Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.
authors.forename: Stephen E
authors.initials: SE
authors.lastname: Wright
authors.affiliation: Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK.
authors.forename: Gillian
authors.initials: G
authors.lastname: Watson
authors.affiliation: Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.
authors.forename: Catherine
authors.initials: C
authors.lastname: Baker
authors.affiliation: Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.
authors.forename: Victoria
authors.initials: V
authors.lastname: Stafford
authors.affiliation: Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.
authors.forename: Clare
authors.initials: C
authors.lastname: Wade
authors.affiliation: Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK.
authors.forename: Thomas J
authors.initials: TJ
authors.lastname: Chadwick
authors.affiliation: Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.
authors.forename: Leigh
authors.initials: L
authors.lastname: Mansfield
authors.affiliation: Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Wilkinson
authors.affiliation: Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK.
authors.forename: Jing
authors.initials: J
authors.lastname: Shen
authors.affiliation: Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK.
authors.forename: Mark
authors.initials: M
authors.lastname: Deverill
authors.affiliation: South Tees Hospitals NHS Foundation Trust, Middlesbrough, UK.
authors.forename: Stephen
authors.initials: S
authors.lastname: Bonner
authors.affiliation: South Tees Hospitals NHS Foundation Trust, Middlesbrough, UK.
authors.forename: Keith
authors.initials: K
authors.lastname: Hugill
authors.affiliation: South Tees Hospitals NHS Foundation Trust, Middlesbrough, UK.
authors.forename: Philip
authors.initials: P
authors.lastname: Howard
authors.affiliation: South Tees Hospitals NHS Foundation Trust, Middlesbrough, UK.
authors.forename: Andrea
authors.initials: A
authors.lastname: Henderson
authors.affiliation: City Hospitals Sunderland NHS Foundation Trust, Sunderland, UK.
authors.forename: Alistair
authors.initials: A
authors.lastname: Roy
authors.affiliation: City Hospitals Sunderland NHS Foundation Trust, Sunderland, UK.
authors.forename: Julie
authors.initials: J
authors.lastname: Furneval
authors.affiliation: Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.
authors.forename: Simon V
authors.initials: SV
authors.lastname: Baudouin
mesh_terms: D000203:Activities of Daily Living; D000328:Adult; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D003422:Critical Care / Q000379:methods*; D016638:Critical Illness / Q000534:rehabilitation*; D005081:Exercise Therapy / Q000379:methods*; D006801:Humans; D051346:Mobility Limitation; D010351:Patient Discharge; D026741:Physical Therapy Modalities; D011788:Quality of Life; D012107:Research Design; D059039:Standard of Care
keywords: INTENSIVE & CRITICAL CARE; Physiotherapy