Technology Assisted Physical Activity Among Hospitalised Medical Patients

Cardiac Disease Clinical Trial

— TAPAS-2  

Official title:

Technology Assisted Physical Activity Among Hospitalised Medical Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04555330
• Other study ID #: FYS-2019-017
• Status: Completed
• Phase: N/A
• Start date: June 11, 2016
• Est. completion date: February 28, 2022

Study information

• Verified date: November 2023
• Source: Frederiksberg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 354
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Disease
• Geriatric Disease
• Heart Diseases
• Pulmonary Disease

Intervention

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.
• 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.

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital, Department of Physical and Occupational Therapy	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Marius Henriksen

Country where clinical trial is conducted

Denmark, 

Outcome

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