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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.
Ward based patients recovering from critical illness who satisfy the inclusion criteria will have an Actigraph GT3X accelerometer positioned on the thigh and ankle of the non dominant leg. These will be used as an objective method of identifying adoption of lying, sitting and standing postures and quantification of step count. Both placement sites will be investigated in isolation. A further analysis will be undertaken to determine whether combining data from both placement sites (ankle and thigh) is superior in identification of lying, sitting and standing postures compared to an isolated single site. Accelerometer data will be compared against direct observation as the criterion measure.
Patients will undertake a semi-structured movement protocol consisting of typical activities undertaken by this population. These include lying in bed, transferring over the side of the bed, sit to stand postural transfers (and the reverse), sitting in a chair and walking. Observation periods will not exceed 3 hours. During this time all aspects of the movement protocol will be completed.
The data from this study will be analysed to determine the validity of the Actigraph GT3X in identification of body position and quantification of step count using the placement sites described above.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Comfort of Accelerometers | Participants were asked to rate their assessment of how comfortable the accelerometers were. They were requested to choose a statement on a five-point Likert Scale. The statements were:
Participants chose the most appropriate statement which they felt reflected how comfortable they found the accelerometers to wear. |
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Inclusion Criteria:
1 18 years of age or above.
2. Ventilated in excess of 48 hours during admission in the Intensive Care Unit (ICU).
3. Currently resident on a hospital ward (secondary care) following step down from ICU
4. Able to undertake all postural transfers independently or with minimal assistance (one person only).
5. Able to mobilise short distances, either independently or with assistance from a walking aid or one person.
6. Willing to permit application of two Actigraph GT3X accelerometers Each device weighs 27g with dimensions of 3.8cm x 3.7cm x 1.8cm.
7. Willing to consent to a period of direct observation for a length of time not exceeding three hours.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jayne Anderson, GradDipPhys | Hull University Teaching Hospitals NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hull and East Yorkshire Hospitals NHS Trust | Hull | East Yorkshire | HU3 2JZ | United Kingdom |
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20 hospital ward based participants recruited. Recruitment period September 2016 to April 2017
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| ID | Title | Description |
|---|---|---|
| FG000 | Accelerometer (Single Group Recruited) | Ward based patients recovering from critical illness will wear two accelerometers placed on the thigh and ankle of the non-dominant leg Accelerometer: 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Accelerometer | Ward based patients recovering from critical illness will wear two accelerometers placed on the thigh and ankle of the non-dominant leg Accelerometer: 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Investigation of agreement between accelerometer quantified step count (ankle and thigh in isolation) and observed step count | Posted | Mean | Full Range | Observed steps | Participants wore the accelerometers for a maximum of 3 hours, undertaking a semi-structured movement protocol |
|
Not exceeding 3 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Accelerometer (Single Group Recruited) | Ward based patients recovering from critical illness will wear two accelerometers placed on the thigh and ankle of the non-dominant leg Accelerometer: 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jayne Anderson | Hull University Teaching Hospitals NHS Trust | 01482 875875 | 5099 | jayne.anderson@hey.nhs.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 1, 2016 | Aug 24, 2017 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 1, 2016 | Aug 24, 2017 | ICF_001.pdf |
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Ankle mounted Actigraph GT3X accelerometer
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| Accelerometers were worn for a period not exceeding 3 hours |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | Years |
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| Gender | Count of Participants | Participants |
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| Body mass index (BMI) | Mean | Standard Deviation | kg/m^2 |
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| Number of days receiving mechanical ventilation | Median | Inter-Quartile Range | days |
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| ICU overall length of stay | Median | Inter-Quartile Range | days |
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| Overall hospital length of stay | Median | Inter-Quartile Range | days |
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| Secondary | Comfort of Accelerometers | Participants were asked to rate their assessment of how comfortable the accelerometers were. They were requested to choose a statement on a five-point Likert Scale. The statements were:
Participants chose the most appropriate statement which they felt reflected how comfortable they found the accelerometers to wear. | Participants were asked to rate accelerometer comfort using a 5-point Likert Scale with the following statements: 'Very comfortable', 'Somewhat comfortable', 'Neither comfortable or uncomfortable', Somewhat uncomfortable', Very uncomfortable' | Posted | Count of Participants | Participants | Accelerometers were worn for a period not exceeding 3 hours |
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| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
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| Somewhat uncomfortable |
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| Very uncomfortable |
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