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

Technology Assisted Physical Activity Among Hospitalised Patients With Respiratory Disease - a Controlled Cohort Study

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Disease
• Intervention / Treatment: Device: Visual feedback of physical activity; Device: Measurement of physical activity; Device: No feedback of physical activity

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2400
    • Bispebjerg Hospital, Department of Physical and Occupational Therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NON_RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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: 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.; Device: No feedback of physical activity; There will be no visual feedback of the physical activity (no monitor placed at the bedside (table)).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Mortality at any time during hospitalisation will be recorded.	7 Days

Collaborators and Investigators

• Sponsor: Marius Henriksen
• Investigators: 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

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2017
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): June 30, 2018

Study Registration Dates

• First Submitted: October 30, 2017
• First Submitted That Met QC Criteria: November 4, 2017
• First Posted (Actual): November 7, 2017

Study Record Updates

• Last Update Posted (Actual): December 7, 2018
• Last Update Submitted That Met QC Criteria: December 6, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiration Disorders; Respiratory Tract Diseases
• Other Study ID Numbers: FYS010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No