Validity of an Actigraph Accelerometer Following Critical Illness

NCT03295630 | Completed Results

• 1 other identifier: R1978
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study will determine whether an Actigraph GT3X accelerometer can identify body position and quantify step count in a ward based population recovering from critical illness.

Conditions

Critical Care; Walking; Posture

Keywords

Accelerometry; Validity

Outcome Measures

Primary Outcomes (1)

• Ability of an Accelerometer to Identify Step Count

  Agreement between direct observation and the activity monitors (ankle and thigh placements in isolation) in determination of step count. The mean difference (95% Limits of Agreement) between observed step count and accelerometer quantified step count for the same walk were calculated. Negative values reflected an underestimation of observed step count by the accelerometer and positive values reflected an overestimation of step count.

  Participants wore the accelerometers for a maximum of 3 hours, undertaking a semi-structured movement protocol

Secondary Outcomes (1)

• Comfort of Accelerometers

  Accelerometers were worn for a period not exceeding 3 hours

Study Arms (1)

Actigraph GT3X accelerometer

OTHER

Ward based patients recovering from critical illness will wear two accelerometers placed on the thigh and ankle of the non-dominant leg

Device: Accelerometer

Interventions

Accelerometer DEVICE

Participants will perform a semi-structured movement protocol to investigate the ability of the Actigraph GT3X accelerometer to identify body position (lying, sitting or standing) and quantify step count.

Actigraph GT3X accelerometer

Eligibility Criteria

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

You may qualify if:

• years of age or above.
• \. Ventilated in excess of 48 hours during admission in the Intensive Care Unit (ICU).
• \. Currently resident on a hospital ward (secondary care) following step down from ICU
• \. Able to undertake all postural transfers independently or with minimal assistance (one person only).
• \. Able to mobilise short distances, either independently or with assistance from a walking aid or one person.
• \. Willing to permit application of two Actigraph GT3X accelerometers Each device weighs 27g with dimensions of 3.8cm x 3.7cm x 1.8cm.
• \. Willing to consent to a period of direct observation for a length of time not exceeding three hours.

You may not qualify if:

• Unable to provide informed written consent themselves
• Unwilling to consent to a period of observation not exceeding three hours.
• Unable to make an informed decision about participation or demonstrating an inability to interpret information or follow study instructions
• Significant neurological or coordination impairment
• Unable to speak or understand English.
• Clostridium Difficile/ similar infection or unmanaged urinary incontinence.
• Evidence/ diagnosis of peripheral vascular disease.
• Lower limb amputation
• Polytrauma which prevents the adoption or normal lying, sitting or standing postures, or placement of the accelerometers

Sponsors & Collaborators

• Hull University Teaching Hospitals NHS Trust: lead

Study Sites (1)

Hull and East Yorkshire Hospitals NHS Trust

Hull, East Yorkshire, HU3 2JZ, United Kingdom

Location

Results Point of Contact

• Title: Dr. Jayne Anderson
• Organization: Hull University Teaching Hospitals NHS Trust

jayne.anderson@hey.nhs.uk

01482 875875

Study Officials

• Jayne Anderson, GradDipPhys

  Hull University Teaching Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Ankle mounted Actigraph GT3X accelerometer

Study Record Dates

• First Submitted: September 25, 2017
• First Posted: September 28, 2017
• Study Start: September 19, 2016
• Primary Completion: April 21, 2017
• Study Completion: April 21, 2017
• Last Updated: October 7, 2019
• Results First Posted: October 7, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)