A Feasibility Study of Early Mobilisation Programmes in Critical Care

NCT03771014 | Completed DMC

• 1 other identifier: UHSEmpress
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness

Keywords

intensive care; physiotherapy; rehabilitation

Outcome Measures

Primary Outcomes (1)

• Physical Function ICU Test-scored

  This is a reliable and valid 4 item scale ( arm strength, leg strength, ability to stand and step cadence),with a score range of 0-10 and is responsive to change and predictive of key outcomes.

  Up to 28 days

Secondary Outcomes (11)

• Medical Research Council Manual Muscle Test Sum Score ( MRC-ss)

  Up to 28 days

• Hand held dynamometry (HHD)

  Up to 12 weeks

• Chelsea Critical Care Physical Assessment tool (CPAX)

  Up to 28 days

• ICU Mobility Scale

  Up to 28 days

• Timed up and go

  Up to 6 months

Study Arms (2)

Early mobility

EXPERIMENTAL

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

Other: Early mobility

Standard care

NO INTERVENTION

Patients will receive standard physiotherapy regimen

Interventions

Early mobility 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

Early mobility

Eligibility Criteria

• Age: 42 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital Southampton NHS Foundation Trust: lead
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (1)

Medway NHS Foundation Trust

Gillingham, Kent, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 35428629 DERIVED

MeSH Terms

Conditions

Critical Illness

Interventions

Early Ambulation

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• Rebecca Cusack, MD

  University Hospital Southampton NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessment at ICU discharge, hospital discharge and 3 month follow-up will be undertaken by an assessor, blinded to study group allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: December 5, 2018
• First Posted: December 10, 2018
• Study Start: May 28, 2019
• Primary Completion: September 23, 2022
• Study Completion: September 23, 2022
• Last Updated: October 27, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Proposals should be addressed to EMPRESS@uhs.nhs.uk

Locations

GB (1)