Technology Assisted Physical Activity Among Hospitalised Medical Patients (TAPAS-2)

Research show that inactivity during hospitalization is the norm and that the negative effects on muscle mass and the fitness of the patient will take a long time and hard work to recover afterwards.

Especially for weaker elderly patients, just a few days in bed could mean that they are not able to take care of themselves afterwards, with increased care expenses and increased risk of relapse as a consequence. Even though this is known, the work to motivate patients to be active during their hospitalization is limited to few training sessions with only the most vulnerable patients. No tools are today available for objectively tracking and motivating patients to be active during their stay. Having such a professional tool would not only motivate but also shift the attention of the health professionals towards the importance of physical activity in the treatment of the patient.

The aim of the studys is to investigate if patients hospitalised for medical disease will increase their time spent out of bed during hospitalisation through simple visual feedback about physical activities from a mobile bedside device.

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease; Cardiac Disease; Geriatric Disease
• Intervention / Treatment: Device: Physical activity measurement; Device: Visual Feedback

Detailed Description

The study will be conducted as a quasi-randomised trial using a large tertiary public hospital in Copenhagen, Denmark. Patients admitted to Department of Respiratory Medicine (2 wards), Department of Cardiology, and Department of Geriatrics will be included, and they will have their physical activity level measured either with or without a bedside monitor providing visual feedback of time spent bedridden, sitting, standing and walking.

All participants will have their physical activity measured during hospitalisation. Approximately half of the participants will receive visual feedback about the amount of physical activity from a mobile device placed on the bedside table.

• Study Type: Interventional
• Enrollment (Actual): 354
• 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

Description

INCLUSION CRITERIA

An individual will be eligible for study participation if he/she meets the following criteria:

1. Is admitted to one of the participating departments
2. Has signed informed consent
3. Reads and speaks Danish

EXCLUSION CRITERIA

An individual will be excluded from the study if he/she meets any of the following criteria:

1. Any condition that, in the opinion of the investigator, makes the person unfit for participation
2. Expected hospitalisation less than 24 hours
3. Has no independent ambulatory abilities (e.g. wheel chair user)
4. Needs personal assistance in body transfers and ambulation (Cumulated Ambulation Score 0, 1, 2, or 3)
5. Has allergy towards band aid

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Visual Feedback; Participants in the intervention group will receive usual hospital care and be provided with a sensor collecting data on physical activity level during hospitalisation AND a monitor placed at their bedside that displays information about their physical activity level and motivation to move. This information will be visible to the health personnel, the patients and visitors.	Device: Physical activity measurement; To assess physical activity two small tri-axial accelerometers embedded in medical Band-Aids will be used. The accelerometers are discretely worn on the lateral aspect of the thigh. The accelerometers sample accelerations continuously during hospitalisation and are connected wirelessly to a tablet that via an inbuilt algorithm classify the recordings as bedridden (lying down), sitting, standing, and walking.; Device: Visual Feedback; The tablet will be placed on the patients bedside table and provides feedback on the amount of physical activity and motivational imagesand texts that will be visible for the patients, the health care staff and visitors.
Other: Control Group; The participants in the non-exposed cohort will receive usual hospital care and be provided with a sensor collecting data on activity level during hospitalisation.No feedback on physical activity is provided.	Device: Physical activity measurement; To assess physical activity two small tri-axial accelerometers embedded in medical Band-Aids will be used. The accelerometers are discretely worn on the lateral aspect of the thigh. The accelerometers sample accelerations continuously during hospitalisation and are connected wirelessly to a tablet that via an inbuilt algorithm classify the recordings as bedridden (lying down), sitting, standing, and walking.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time spent out of bed measured in minutes related to the total accelerometer wear time (minutes).	Through hospital stay, on average between 1 and 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time spent lying down, measured in minutes related to the total accelerometer wear time (minutes).		Through hospital stay, on average between 1 and 7 days
Time spent sitting measured in minutes related to the total accelerometer wear time (minutes).		Through hospital stay, on average between 1 and 7 days
Time spent standing measured in minutes related to the total accelerometer wear time (minutes).		Through hospital stay, on average between 1 and 7 days
Time spent walking measured in minutes related to the total accelerometer wear time (minutes).		Through hospital stay, on average between 1 and 7 days
Length of stay	Length of hospitalisation measured in days	Time from hospital admission to hospital discharge
Readmission to hospital		within 90 days
In-hospital fall incidents	Number of falls recorded	Through hospital stay, on average between 1 and 7 days

Collaborators and Investigators

• Sponsor: Marius Henriksen

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2016
• Primary Completion (Actual): February 28, 2022
• Study Completion (Actual): February 28, 2022

Study Registration Dates

• First Submitted: September 7, 2020
• First Submitted That Met QC Criteria: September 14, 2020
• First Posted (Actual): September 18, 2020

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases
• Other Study ID Numbers: FYS-2019-017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD can be shared upon request sen to the sponsor and/or invesitgators

Drug and device information, study documents

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