Technology Assisted Physical Activity Among Hospitalised Patients With Respiratory Disease

NCT03333850 | Completed

• 1 other identifier: FYS010
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Time spent sitting during hospitalisation

  7 Days

• Time spent standing during hospitalisation

  7 Days

• Time spent walking during hospitalisation

  7 Days

Other Outcomes (1)

• Mortality

  7 Days

Study Arms (2)

Visual feedback of physical activity

EXPERIMENTAL

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

No feedback of physical activity

ACTIVE COMPARATOR

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

Interventions

Visual feedback of physical activity DEVICE

A monitor (tablet) will display the level of physical activity during hospitalisation. The monitor will be placed at the bedside (table).

Visual feedback of physical activity

No feedback of physical activity DEVICE

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

No feedback of physical activity

Measurement of physical activity DEVICE

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.

No feedback of physical activity; Visual feedback of physical activity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is admitted to the Department of Respiratory Medicine
• Has signed informed consent
• Reads and speaks Danish

You may not qualify if:

• Any condition that, in the opinion of the investigator, makes the person unfit for participation
• Has allergy towards band aid

Sponsors & Collaborators

• Marius Henriksen: lead

Study Sites (1)

Bispebjerg Hospital, Department of Physical and Occupational Therapy

Copenhagen, 2400, Denmark

Location

MeSH Terms

Conditions

Respiration Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• Christian H Dall, PhD

  Department of Physio- and Occupational Therapy, Bispebjerg-Frederiksberg Hospital, Denmark

  STUDY DIRECTOR

• Marius Henriksen, PhD

  Department of Physio- and Occupational Therapy, Bispebjerg-Frederiksberg Hospital, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: October 30, 2017
• First Posted: November 7, 2017
• Study Start: November 8, 2017
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: December 7, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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

Locations

DK (1)