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Completed

NCT Number: NCT04555330

Technology Assisted Physical Activity Among Hospitalised Medical Patients

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.

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Key information

Conditions

Pulmonary Disease Cardiac Disease Cardiovascular Diseases Geriatric Disease Heart Diseases Lung Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bispebjerg Hospital, Department of Physical and Occupational Therapy

Copenhagen, 2400, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

  • Is admitted to one of the participating departments
  • Has signed informed consent
  • Reads and speaks Danish

Exclusion criteria

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

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

Treatment and study plan

Physical activity measurement

Device

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

Device

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.

Primary outcomes

  1. Time spent out of bed measured in minutes related to the total accelerometer wear time (minutes).

    Time frame: Through hospital stay, on average between 1 and 7 days

Secondary outcomes

  1. Time spent lying down, measured in minutes related to the total accelerometer wear time (minutes).

    Time frame: Through hospital stay, on average between 1 and 7 days

  2. Time spent sitting measured in minutes related to the total accelerometer wear time (minutes).

    Time frame: Through hospital stay, on average between 1 and 7 days

  3. Time spent standing measured in minutes related to the total accelerometer wear time (minutes).

    Time frame: Through hospital stay, on average between 1 and 7 days

  4. Time spent walking measured in minutes related to the total accelerometer wear time (minutes).

    Time frame: Through hospital stay, on average between 1 and 7 days

  5. Length of stay

    Time frame: Time from hospital admission to hospital discharge

    Length of hospitalisation measured in days

  6. Readmission to hospital

    Time frame: within 90 days

  7. In-hospital fall incidents

    Time frame: Through hospital stay, on average between 1 and 7 days

    Number of falls recorded

Sponsors and collaborators

Lead sponsor

Marius Henriksen

Other

Registry information

Acronym: TAPAS-2

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Sep 18, 2020
Registry last updated
Nov 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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