Clinical trial NCT03771014: A Feasibility Study of Early Mobilisation Programmes in Critical Care
Official title: EMPRESS: A Feasibility Study of Early Mobilisation Programmes in Critical Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Keywords: intensive care
physiotherapy
rehabilitation
Lead sponsor: University Hospital Southampton NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
First posted: 2018-12-10
Enrollment: 46
Sex: ALL
Minimum age (years): 42
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Feasibility study of two-arm pilot RCT, randomised 1:1 with blinded outcome assessments
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of this study is to determine the feasibility of delivering a very early mobility rehabilitation program in Intensive Care Units (ICU), within the context of a randomised controlled trial (RCT). This will inform the design of a future RCT investigating very early ICU rehabilitation in the UK National Health Service.

Detailed description: Early ICU-based physical rehabilitation may benefit patients with acute severe respiratory failure by attenuating the development of severe and persistent weakness and impaired physical function seen in these patients.

Muscle wasting occurs early (within 12 hours) and progresses rapidly after ICU admission. Patients may suffer from consequent physical impairment for months or years following their discharge.

ICU based rehabilitation has the potential to improve physical function outcomes, through mitigating muscle wasting.

The investigators have successfully introduced a very early ICU mobility program in their institution, which results in increased ventilator free days and reduced length of ICU stay.

The primary aim is to investigate whether this method will work in other ICUs. EMPRESS will test the feasibility of running this intervention as an RCT. The results and a concurrent process evaluation will inform the design of a future, multi-centre randomised controlled trial.

Eligibility criteria: Inclusion Criteria:

* Acute/unplanned medical admissions to the ICU.
* \> 42 years old.
* Functionally independent prior to ICU admission (Barthel \>80).
* In hospital for \<5 days prior to intubation and ventilation.
* Intubated and ventilated for \<72 hrs.
* Expected to remain ventilated for a further 48 hours.

Exclusion Criteria:

* In hospital for 5 days or more prior to ITU admission.
* Patients with acute brain or spinal cord injury.
* Known or suspected neurological / muscular impairment.
* Condition limiting use of cycle ergometer e.g. lower limb fracture / amputation.
* Not expected to survive \>48hrs.
* Persistent therapy exemptions in first 3 days of mechanical ventilation.
* Body habitus such as unable to use cycle ergometer.
* Consultant clinician view that patient not suitable or not expected to survive admission.

Primary outcomes:
measure: Physical Function ICU Test-scored
timeFrame: Up to 28 days
Secondary outcomes:
measure: Medical Research Council Manual Muscle Test Sum Score ( MRC-ss)
timeFrame: Up to 28 days
measure: Hand held dynamometry (HHD)
timeFrame: Up to 12 weeks
measure: Chelsea Critical Care Physical Assessment tool (CPAX)
timeFrame: Up to 28 days
measure: ICU Mobility Scale
timeFrame: Up to 28 days
measure: Timed up and go
timeFrame: Up to 6 months
measure: Clinical Frailty Score
timeFrame: Up to 6 months
measure: Barthel Index for Activities of Daily Living
timeFrame: Up to 6 months
measure: Six minute walk test
timeFrame: Up to 6 months
measure: The Hospital Anxiety and Depression Scale - HADS
timeFrame: 6 months
measure: WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)
timeFrame: 6 months
measure: EQ-5D-5L
timeFrame: 6 months
Other outcomes:
Locations:
city: Gillingham
country: United Kingdom
facility: Medway NHS Foundation Trust
state: Kent
Study officials:
affiliation: University Hospital Southampton NHS Foundation Trust
name: Rebecca Cusack, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cusack R, Bates A, Mitchell K, van Willigen Z, Denehy L, Hart N, Dushianthan A, Reading I, Chorozoglou M, Sturmey G, Davey I, Grocott M. Improving physical function of patients following intensive care unit admission (EMPRESS): protocol of a randomised controlled feasibility trial. BMJ Open. 2022 Apr 15;12(4):e055285. doi: 10.1136/bmjopen-2021-055285.