EPICC

Intensive versus standard physical rehabilitation therapy in the critically ill (EPICC): a multicentre, parallel-group, randomised controlled trial

Wright. 2017. Thorax 2017: 0:1–9. doi:10.1136/thoraxjnl-2016-209858

Clinical Question

  • Does an increased intensity of ICU based physical rehabilitation therapy improve improve long-term physical quality of life compared with a standard intensity of physical rehabilitation?

Background

  • Physical and psychological recovery after a period of critical illness is slow and often incomplete
  • Current evidence informs us that patients report ongoing physical and psychological problems, and a decreased quality of life, for up to 5 years after their original illness
  • Whilst the aetiology of critical illness neuromyopathy is multifactorial, limiting the period of immobility and promoting movement and exercise are intuitively attractive strategies to prevent muscle weakness and enhance recovery

Design

  • Randomised controlled trial
  • Patients were randomised to increased intensity or standard physiotherapy in a 1:1 ratio, stratified by admitting ICU, admission type and level of independence (Katz Index)
  • Allocation-concealed
  • Participants, research physiotherapists and the wider clinical team were not blinded to the treatment group
  • Participants were followed until hospital discharge and invited to attend a follow-up at their hospital 3 and 6months after randomisation. Follow-up questionnaires could be completed by telephone if participants were unable to attend in person
  • A sample size calculation based on a difference of five points in the primary outcome (mean Physical Component Summary (PCS) measure of the 36 item Short Form Survey (SF-36)), 80% power and a significance level of 0.05 required 77 patients to contribute primary outcome data at 6 months. Allowing for a mortality rate of 40% and a further 10% loss to follow-up required 154 in each group. At 6 months 116 patients (of 308 randomised) contributed primary outcome data (99 had died, 16 had withdrawn and 77 were lost to follow up)

Setting

  • 4 mixed medical-surgical ICUs in 4 UK hospitals
  • Jan 2012 – Dec 2014

Population

  • Inclusion: 18 years or older and had received 48 hours or more of either invasive or non-invasive ventilation
  • Exclusion: End-of-life care; acute brain or spinal cord injury (or admitted following brain or spinal cord surgery); multiple trauma if mobilisation therapy was judged unlikely to be possible; burns; rapidly progressive neuromuscular disease; patients enrolled in another clinical trial without a co-enrolment agreement in place; and patients previously enrolled in this trial. Patients could be recruited following a cardiac arrest if the clinical team believed there was a possibility of recovery
  • 308 patients
  • Similar baseline characteristics in both study groups although the proportion of males in the intensive group (54%) was lower than in the standard group (63%). Most patients were emergency admissions with similar illness severity scores (mean APACHE II was 19) and high pre-hospital independence
    • Mean duration of ICU ventilation (days) was 4 in both groups
    • Almost all patients received invasive ventilation (>98%)
    • ICU length of stay was similar: mean 5-6 days

Intervention

  • Intensive physical rehabilitation
  • Target delivery of 90 min of physical rehabilitation per day (Monday to Friday), split between at least two sessions

Control

  • Standard care physical rehabilitation
  • Target of 30 min of physical rehabilitation per day (Monday to Friday)

Management common to both groups

  • All physical rehabilitation sessions were preceded by a sedation hold (or titration) with a target Richmond Agitation-Sedation Scale (RASS) of −1, 0 or +1
    • Patients were considered safe enough to undertake a sedation hold (or titration) in 88% (n= 4079) of the intensive group and 85% (n=2141) of the standard care group
    • 51% of the intensive group vs 53% of standard care group had a successful sedation hold (or titration) and passed the safety screen
  • The physical rehabilitation therapy included functional training and individually tailored exercise programmes and was delivered by experienced critical care physiotherapists
  • Following discharge from ICU, both groups received routine ward-based physiotherapy and an exercise diary to continue independently on discharge from hospital
  • Any participant readmitted to ICU received standard physical rehabilitation during their first and any subsequent readmissions

Outcome

  • Primary outcome: Mean Physical Component Summary (PCS) measure of the 36 item Short Form Survey (SF-36) Quality of Life questionnaire at 6 months was similar in both groups
    • 37 (SD 12.2) in the intervention group vs 37 (SD 11.3) in the standard care group
  • Secondary outcome: all similar between groups (intervention vs standard care) across all follow-up time points apart from the Functional Independence Measure at 3 months
    • Mean Mental Health Component Summary (MCS) measure of the SF-36
      • 40 vs 39 at hospital discharge
      • 47 vs 45 at 3 months
      • 47 vs 48 at 6 months
    • Mean physical ability at ICU discharge (Modified Rivermead Mobility Index)
      • 19 vs 16 at ICU discharge
    • Median length of ICU stay (alive at ICU discharge)
      • 13 vs 15 days
    • Median hospital length of stay (alive at hospital discharge)
      • 28 vs 28 days
    • Exercise capacity based on median metres for 6 min walk test
      • 195 vs 173 at hospital discharge
      • 293 vs 255 at 3 months
      • 374 vs 321 at 6 months
    • Mean Functional status (Functional Independence Measure)
      • 70 vs 64 at ICU discharge
      • 113 vs 108 at hospital discharge
      • 116 vs 111 at 3 months
      • 118 vs 117 at 6 months
    • Mean hand grip strength
      • 14 vs 15 at ICU discharge
      • 19 vs 22 at hospital discharge
      • 25 vs 24 at 3 months
      • 29 vs 24 at 6 months
  • Other
    • Median (IQR) no of days from enrolment to the first day when physical rehabilitation was received was 3 (1-6 days) in both groups
    • Median time (IQR) receiving physical rehabilitation on ICU: intervention group 161 minutes (67-273) vs standard care group 86 (31-139)

Authors’ Conclusions

  • In this study, ICU based physical rehabilitation did not appear to improve physical outcomes at 6 months compared with standard physical rehabilitation

Strengths

  • Registered with ISRCTN (20436833)
  • Protocol published a priori
  • Pretrial power calculation
  • Large range of general critical care patients included
  • Multi-centre study (although limited to 3 centres in the north of England)
  • Delivery of rehabilitation in the control group
  • Prolonged follow up of 6 months
  • Study outcomes at hospital discharge and at 3 and 6-month follow-up were assessed by research nurses who were blinded to the treatment group
  • Timings for characteristics of physical rehabilitation (functional retraining, strengthening and both) were recorded

Weaknesses

  • Number of sites
  • Lack of 7-day rehabilitation interventions
  • Study outcomes at ICU discharge were assessed by the research physiotherapists who were unblinded to the treatment group
  • The original (and registered) version of the protocol listed 48–72 hours for the inclusion time but the upper limit was removed 2 months into recruitment as the time window proved too narrow and eligible patients were being missed, especially at weekends
  • The majority of treatment days in the standard care group included less than the target of 30 min physical rehabilitation, with 82% of treatment days including 20 min or less
  • The PCS measure of the SF-36 may not have been sensitive to change as it includes scoring coefficients from all 8 domains of the SF-36, including the negative scoring coefficients ‘role emotional’ and ’emotional well-being’, which may not have been affected by the intervention
  • 77 patients (25% of total participants) were lost to follow up
  • Over 2 years from follow up data being available to publication. Practice may have changed during this period

The Bottom Line

  • In this study, delivering more ICU-based physical rehabilitation did not appear to improve physical outcomes at 6 months
  • Patient tolerance, a non 7-day ICU rehabilitation service, poor compliance with the minimum time for sessions in the standard care group, and high loss of patients to follow up, are important confounders
  • Future work might concentrate on individualised, structured rehabilitation programme and optimising sedation protocols to facilitate these sessions. We also need a better understanding of the varying recovery trajectories after critical illness and the impact of psychological rehabilitation

External Links

Metadata

Summary author: Steve Mathieu
Summary date: 15th August 2017
Peer-review editor: Adrian Wong

Leave a Reply