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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03333850
Other study ID # FYS010
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 8, 2017
Est. completion date June 30, 2018

Study information

Verified date December 2018
Source Frederiksberg University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to investigate if patients hospitalised for medical disease will increase their time spent out of bed during hospitalisation through simple feedback about physical activities from a mobile device.

Physical activity is measured by means of a pair of accelerometers embedded in band aids placed on the thigh and on the chest. The measurement is continuous and data is uploaded to a secure internet-server. Summaries of physical activity (bedrest, sitting, standing, walking) is computed and can be displayed on a mobile device (tablet) through a dedicated application.

The study will be conducted as a controlled cohort study in a large tertiary public hospital in Copenhagen, Denmark. Patients admitted to Department of Respiratory Medicine will be included and will have their physical activity measured during hospitalisation. Half of the cohort will receive visual feedback about the amount of physical activity from a mobile device placed on the bed table.

A total of 108 patients will be included resulting in 6 periods of 18 patients each.


Recruitment information / eligibility

Status Completed
Enrollment 96
Est. completion date June 30, 2018
Est. primary completion date June 30, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Is admitted to the Department of Respiratory Medicine

2. Has signed informed consent

3. Reads and speaks Danish

Exclusion Criteria:

1. Any condition that, in the opinion of the investigator, makes the person unfit for participation

2. Has allergy towards band aid

Study Design


Intervention

Device:
Visual feedback of physical activity
A monitor (tablet) will display the level of physical activity during hospitalisation. The monitor will be placed at the bedside (table).
No feedback of physical activity
There will be no visual feedback of the physical activity (no monitor placed at the bedside (table)).
Measurement of physical activity
A pair of accelerometers placed on the chest and on the thigh will measure the physical activity level during hospitalisation. The measurement is made continuously and stored on a secure web-server.

Locations

Country Name City State
Denmark Bispebjerg Hospital, Department of Physical and Occupational Therapy Copenhagen

Sponsors (1)

Lead Sponsor Collaborator
Marius Henriksen

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Other Mortality Mortality at any time during hospitalisation will be recorded. 7 Days
Primary Time spent out of bed during hospitalisation Time (in minutes) spent out of bed measured in minutes related to the total hospitalisation time. The time spent out of bed will be recorded throughout the hospitalisation for a maximum of 7 days. 7 Days
Secondary Time spent sitting during hospitalisation Time (in minutes) spent sitting related to the total hospitalisation time. The time sitting will be recorded throughout the hospitalisation for a maximum of 7 days. 7 Days
Secondary Time spent standing during hospitalisation Time (in minutes) spent standing related to the total hospitalisation time. The time standing will be recorded throughout the hospitalisation for a maximum of 7 days. 7 Days
Secondary Time spent walking during hospitalisation Time (in minutes) spent walking related to the total hospitalisation time. The time walking will be recorded throughout the hospitalisation for a maximum of 7 days. 7 Days
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