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

Primary Purpose

Respiratory Disease

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Visual feedback of physical activity
No feedback of physical activity
Measurement of physical activity
Sponsored by
Marius Henriksen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Respiratory Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bispebjerg Hospital, Department of Physical and Occupational Therapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Visual feedback of physical activity

No feedback of physical activity

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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 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 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.

Full Information

First Posted
October 30, 2017
Last Updated
December 6, 2018
Sponsor
Marius Henriksen
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1. Study Identification

Unique Protocol Identification Number
NCT03333850
Brief Title
Technology Assisted Physical Activity Among Hospitalised Patients With Respiratory Disease
Acronym
TAPAS
Official Title
Technology Assisted Physical Activity Among Hospitalised Patients With Respiratory Disease - a Controlled Cohort Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
November 8, 2017 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Marius Henriksen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Disease

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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)
Allocation
Non-Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Visual feedback of physical activity
Arm Type
Experimental
Arm Description
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.
Arm Title
No feedback of physical activity
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Visual feedback of physical activity
Intervention Description
A monitor (tablet) will display the level of physical activity during hospitalisation. The monitor will be placed at the bedside (table).
Intervention Type
Device
Intervention Name(s)
No feedback of physical activity
Intervention Description
There will be no visual feedback of the physical activity (no monitor placed at the bedside (table)).
Intervention Type
Device
Intervention Name(s)
Measurement of physical activity
Intervention Description
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 Measure Information:
Title
Time spent out of bed during hospitalisation
Description
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
Secondary Outcome Measure Information:
Title
Time spent sitting during hospitalisation
Description
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
Title
Time spent standing during hospitalisation
Description
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
Title
Time spent walking during hospitalisation
Description
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
Other Pre-specified Outcome Measures:
Title
Mortality
Description
Mortality at any time during hospitalisation will be recorded.
Time Frame
7 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Is admitted to the Department of Respiratory Medicine Has signed informed consent Reads and speaks Danish Exclusion Criteria: Any condition that, in the opinion of the investigator, makes the person unfit for participation Has allergy towards band aid
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian H Dall, PhD
Organizational Affiliation
Department of Physio- and Occupational Therapy, Bispebjerg-Frederiksberg Hospital, Denmark
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Marius Henriksen, PhD
Organizational Affiliation
Department of Physio- and Occupational Therapy, Bispebjerg-Frederiksberg Hospital, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bispebjerg Hospital, Department of Physical and Occupational Therapy
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
When data has been anonymised, analysed, and the scientific report(s) published.
IPD Sharing Access Criteria
The are no criteria specified at this time

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Technology Assisted Physical Activity Among Hospitalised Patients With Respiratory Disease

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