Trial Outcomes & Findings for Validity of an Actigraph Accelerometer Following Critical Illness (NCT NCT03295630)

Last Updated: 2019-10-07

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

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

Results posted on

2019-10-07

Participant Flow

20 hospital ward based participants recruited. Recruitment period September 2016 to April 2017

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Accelerometer n=20 Participants 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
Age, Continuous	62.3 years STANDARD_DEVIATION 11.5 • n=20 Participants
Sex: Female, Male Female	7 Participants n=20 Participants
Sex: Female, Male Male	13 Participants n=20 Participants
Region of Enrollment United Kingdom	20 Years n=20 Participants
Gender Male	13 Participants n=20 Participants
Gender Female	7 Participants n=20 Participants
Body mass index (BMI)	25.9 kg/m^2 STANDARD_DEVIATION 6.1 • n=20 Participants
Number of days receiving mechanical ventilation	15 days n=20 Participants
ICU overall length of stay	21 days n=20 Participants
Overall hospital length of stay	35 days n=20 Participants

PRIMARY outcome

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

Population: Investigation of agreement between accelerometer quantified step count (ankle and thigh in isolation) and observed step count

Outcome measures

Outcome measures
Measure	Accelerometer n=20 Participants 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
Ability of an Accelerometer to Identify Step Count	46 Observed steps Interval 15.0 to 90.0

SECONDARY outcome

Timeframe: Accelerometers were worn for a period not exceeding 3 hours

Population: 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'

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: 1. Very uncomfortable 2. Somewhat uncomfortable 3. Neither comfortable nor uncomfortable 4. Somewhat comfortable 5. Very comfortable Participants chose the most appropriate statement which they felt reflected how comfortable they found the accelerometers to wear.

Outcome measures

Outcome measures
Measure	Accelerometer n=20 Participants 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
Comfort of Accelerometers Very Comfortable	16 Participants
Comfort of Accelerometers Somewhat comfortable	3 Participants
Comfort of Accelerometers Neither comfortable or uncomfortable	0 Participants
Comfort of Accelerometers Somewhat uncomfortable	1 Participants
Comfort of Accelerometers Very uncomfortable	0 Participants

Adverse Events

Accelerometer (Single Group Recruited)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jayne Anderson

Hull University Teaching Hospitals NHS Trust

Phone: 01482 875875

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place