An interventional study of Visual feedback of physical activity and No feedback of physical activity in Respiratory Disease, sponsored by Marius Henriksen. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-12-07.
Sponsored by Marius Henriksen · Not applicable, Interventional, and Supportive care
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.
359 studies on the registry are indexed under Respiration Disorders; 64 are open to participants now.
This study's enrollment of 96 is above the median of 69 across 216 interventional studies indexed under Respiration Disorders.
Browse Respiration Disorders studies →Marius Henriksen is the lead sponsor of 18 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in the exposure cohort will receive usual hospital care and continuous measurement of physical activity by sensors collecting physical activity level during hospitalisation AND a monitor placed at their bedside that displays information about their physical activity level, in terms of time spent bedridden, sitting, standing and walking. This information will be visible to the health personnel, the patients and their relatives.
Device: Visual feedback of physical activity · Device: Measurement of physical activity
The participants in the non-exposure cohort will receive usual hospital care and continuous measurement of physical activity by sensors collecting physical activity level during hospitalisation. No visual feedback is provided.
Device: No feedback of physical activity · Device: Measurement of physical activity
A monitor (tablet) will display the level of physical activity during hospitalisation. The monitor will be placed at the bedside (table).
There will be no visual feedback of the physical activity (no monitor placed at the bedside (table)).
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.
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.
Time frame: 7 Days
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.
Time frame: 7 Days
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.
Time frame: 7 Days
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.
Time frame: 7 Days
Mortality
Mortality at any time during hospitalisation will be recorded.
Time frame: 7 Days
Plan to share: Yes — When data has been anonymised, analysed, and the scientific report(s) published, the data will be made available to other researchers. Availability will be through direct contact to the study director or principal investigator.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: When data has been anonymised, analysed, and the scientific report(s) published.
Access criteria: The are no criteria specified at this time
No publications or documents are linked to this record.
Ran from Nov 2017 to primary completion in Jun 2018, 7 months.
Of 91 non-industry interventional studies with no phase under Respiration Disorders, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 37. This study's 7 months is below that.
Counting every sponsor, half of 111 studies reached it within 18 months; a quarter within 7 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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Marius Henriksen