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Technology Assisted Physical Activity Among Hospitalised Patients With Respiratory Disease (TAPAS)

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ClinicalTrials.gov Identifier: NCT03333850
Recruitment Status : Completed
First Posted : November 7, 2017
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
Marius Henriksen, Frederiksberg University Hospital

Brief 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.


Condition or disease Intervention/treatment Phase
Respiratory Disease Device: Visual feedback of physical activity Device: No feedback of physical activity Device: Measurement of physical activity Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: There will be sequential inclusion to each cohort. Each sequence includes 18 patients (corresponding to the number of beds at the department). Thus the patients hospitalised during the first period will receive feedback (exposed cohort). In the second period the patients will not receive feedback (non-exposed cohort), and so forth. A total of 108 patients will be included resulting in 6 periods of 18 patients each.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Technology Assisted Physical Activity Among Hospitalised Patients With Respiratory Disease - a Controlled Cohort Study
Actual Study Start Date : November 8, 2017
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Visual feedback of physical activity
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
A monitor (tablet) will display the level of physical activity during hospitalisation. The monitor will be placed at the bedside (table).

Device: 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.

Active Comparator: No feedback 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
There will be no visual feedback of the physical activity (no monitor placed at the bedside (table)).

Device: 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.




Primary Outcome Measures :
  1. Time spent out of bed during hospitalisation [ Time Frame: 7 Days ]
    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.


Secondary Outcome Measures :
  1. Time spent sitting during hospitalisation [ Time Frame: 7 Days ]
    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.

  2. Time spent standing during hospitalisation [ Time Frame: 7 Days ]
    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.

  3. Time spent walking during hospitalisation [ Time Frame: 7 Days ]
    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.


Other Outcome Measures:
  1. Mortality [ Time Frame: 7 Days ]
    Mortality at any time during hospitalisation will be recorded.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03333850


Locations
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Denmark
Bispebjerg Hospital, Department of Physical and Occupational Therapy
Copenhagen, Denmark, 2400
Sponsors and Collaborators
Marius Henriksen
Investigators
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Study Director: Christian H Dall, PhD Department of Physio- and Occupational Therapy, Bispebjerg-Frederiksberg Hospital, Denmark
Principal Investigator: Marius Henriksen, PhD Department of Physio- and Occupational Therapy, Bispebjerg-Frederiksberg Hospital, Denmark
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Responsible Party: Marius Henriksen, Professor, Frederiksberg University Hospital
ClinicalTrials.gov Identifier: NCT03333850    
Other Study ID Numbers: FYS010
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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 Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: When data has been anonymised, analysed, and the scientific report(s) published.
Access Criteria: The are no criteria specified at this time

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiration Disorders
Respiratory Tract Diseases