Measuring Physical Activity Levels in Critical Care

NCT03454880 | Completed

• 1 other identifier: 18IR06
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The study will be a single-centre, prospective observational study to evaluate the use of a wearable accelerometer device to measure physical activity levels of patients within critical care.

Conditions

Critical Care

Keywords

Accelerometry; Wearable electronic devices

Outcome Measures

Primary Outcomes (4)

• Wear time

  Amount of time device worn (hours per day)

  Until discharge from critical care, up to 12 weeks maximum.

• Number of days worn

  Number of days worn for at least minimum requirement (10 hours per day)

  Until discharge from critical care, up to 12 weeks maximum.

• Number of adverse events

  Number of adverse events occuring during device wear

  Until discharge from critical care, up to 12 weeks maximum.

• Percentage agreement with observation

  Percentage of activities observed by nursing staff recorded by device

  Until discharge from critical care, up to 12 weeks maximum.

Secondary Outcomes (3)

• Time spent performing activity

  Until discharge from critical care, up to 12 weeks maximum.

• Time spent in chair

  Until discharge from critical care, up to 12 weeks maximum.

• Time spent in bed

  Until discharge from critical care, up to 12 weeks maximum.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study participants will be patients admitted to University Hospital Wales critical care unit. It is a 33 bedded mixed unit, providing tertiary care for patients from across South and West Wales. Nursing care is provided 1:1 for level 3 care and 1:2 for level 2 care. Patients present with a wide range of medical conditions including post-surgery, polytrauma, respiratory failure and neurological injury. The severity of illness will be variable, but patients admitted to critical care will require support for at least one organ. The majority of patients are likely to be sedated and mechanically ventilated on admission to the unit or shortly afterwards. Patients at high risk of developing physical morbidity will be recruited.

You may qualify if:

• Age \>18
• 'At risk' of physical morbidity as determined by National Institute for Health and Care Excellence (NICE) Clinical Guideline 83
• Advice from consultee for participation and patient re-consent if appropriate for continuing participation

You may not qualify if:

• Age \<18
• Expected to die during admission
• Failure to obtain consent or advice,
• Pre-existing neuromuscular disease
• Unable to wear accelerometer device
• Open abdomen
• Active neurological event requiring intervention (e.g. External Ventricular Drain, Intracranial Pressure bolt)
• Acute spinal cord injury
• Lower extremity fractures
• Bedbound prior to admission

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

Univeristy Hospital Wales

Cardiff, CF14 4XW, United Kingdom

Location

Related Publications (1)

• Connolly BA, Mortimore JL, Douiri A, Rose JW, Hart N, Berney SC. Low Levels of Physical Activity During Critical Illness and Weaning: The Evidence-Reality Gap. J Intensive Care Med. 2019 Oct;34(10):818-827. doi: 10.1177/0885066617716377. Epub 2017 Jul 4.

  PMID: 28675113 BACKGROUND

Study Officials

• Laura M Jones

  Student

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2018
• First Posted: March 6, 2018
• Study Start: April 9, 2018
• Primary Completion: June 28, 2018
• Study Completion: June 28, 2018
• Last Updated: March 26, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)