A Feasibility Study of Early Mobilisation Programmes in Critical Care

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-28

Study Completion Date

2022-09-23

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Critical Illness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Feasibility study of two-arm pilot RCT, randomised 1:1 with blinded outcome assessments

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Outcome assessment at ICU discharge, hospital discharge and 3 month follow-up will be undertaken by an assessor, blinded to study group allocation.

Study Groups

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Early mobility

Patients will receive standard physiotherapy regimen plus 2 x 30 minute rehabilitation sessions 5 days per week.

Group Type EXPERIMENTAL

Early mobility

Intervention Type OTHER

This progressive mobility pathway commenced with passive cycling within 48 hours of intubation and ventilation and progressing through assisted cycling, active cycling, bed exercises, sitting, mobilising out of bed to walking

Standard care

Patients will receive standard physiotherapy regimen

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Early mobility

This progressive mobility pathway commenced with passive cycling within 48 hours of intubation and ventilation and progressing through assisted cycling, active cycling, bed exercises, sitting, mobilising out of bed to walking

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

42 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No