Pulmonary DiseaseTAPAS-2NCT04555330
Technology Assisted Physical Activity Among Hospitalised Medical Patients
A study testing Physical activity measurement and Visual Feedback in people with Pulmonary Disease and Cardiac Disease, run by Marius Henriksen at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Disease, Cardiac Disease, Geriatric Disease
- What is being tested?
- Physical activity measurement and Visual Feedback
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 354 participants
- Where
- 1 siteDenmark
- Study dates
- 11 Jun 2016to 28 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Bispebjerg Hospital, Department of Physical and Occupational Therapy
Copenhagen, 2400
About this study
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.
Read the 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.
- Conditions
- Pulmonary Disease, Cardiac Disease, Geriatric Disease
- Being tested
- Physical activity measurement, Visual Feedback
- Medical subject headings
- Lung Diseases, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity measurementDevice
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 FeedbackDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Visual Feedback | Experimental | 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. Receives: Device: Physical activity measurement; Device: Visual Feedback |
| Control Group | Other | 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. Receives: Device: Physical activity measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time spent out of bed measured in minutes related to the total accelerometer wear time (minutes).
Measured: Through hospital stay, on average between 1 and 7 days
Secondary outcomes (7)
Time spent lying down, measured in minutes related to the total accelerometer wear time (minutes).
Measured: Through hospital stay, on average between 1 and 7 days
Time spent sitting measured in minutes related to the total accelerometer wear time (minutes).
Measured: Through hospital stay, on average between 1 and 7 days
Time spent standing measured in minutes related to the total accelerometer wear time (minutes).
Measured: Through hospital stay, on average between 1 and 7 days
Time spent walking measured in minutes related to the total accelerometer wear time (minutes).
Measured: Through hospital stay, on average between 1 and 7 days
Length of stay
Length of hospitalisation measured in days
Measured: Time from hospital admission to hospital discharge
Readmission to hospital
Measured: within 90 days
In-hospital fall incidents
Number of falls recorded
Measured: Through hospital stay, on average between 1 and 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start11 Jun 2016
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The allocation of participants will be done in 8 waves at each of the participating wards. At each hospital ward, 4 of the waves will be allocated to the control group and 4 to the intervention group. The order of the conditions is randomised. A participant will be assigned to the wave that the ward is allocated to at the time of admission. The wave size for each ward is set to 10 patients. Assignment of the waves at each department will be determined before any recruitment by means of Latin square randomisation in 2 blocks of 4 waves at the 4 participating wards.
- Masking
- None (open label)
- Enrolment
- 354 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marius Henriksen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marius Henriksen, Frederiksberg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04555330
- Sponsor's protocol ID
- FYS-2019-017
- Acronym
- TAPAS-2
- Status last verified
- Nov 2023
- First submitted
- 7 Sep 2020
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD can be shared upon request sen to the sponsor and/or invesitgators
Publications
Dall CH, Gunnarsson DV, Suetta C, Pedersen L, Prescott E, Henriksen M. Technology-assisted physical activity among hospitalized medical patients: a cluster randomized trial. Eur J Prev Cardiol. 2026 Jun 30:zwag210. doi: 10.1093/eurjpc/zwag210. Online ahead of print.
PubMed 42378437
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology Assisted Physical Activity Among Hospitalised Medical Patients
- ClinicalTrials.gov ID
- NCT04555330
- Acronym / sponsor ID
- TAPAS-2 / FYS-2019-017
- Conditions
- Pulmonary Disease, Cardiac Disease, Geriatric Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 354 participants (actual)
- Lead sponsor
- Marius HenriksenUniversity, hospital or other
- Study start
- 11 Jun 2016 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 18 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The allocation of participants will be done in 8 waves at each of the participating wards. At each hospital ward, 4 of the waves will be allocated to the control group and 4 to the intervention group. The order of the conditions is randomised. A participant will be assigned to the wave that the ward is allocated to at the time of admission. The wave size for each ward is set to 10 patients. Assignment of the waves at each department will be determined before any recruitment by means of Latin square randomisation in 2 blocks of 4 waves at the 4 participating wards.
| Arm | Type | Receives |
|---|---|---|
| Visual Feedback | Experimental | Device: Physical activity measurement, Device: Visual FeedbackParticipants 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. |
| Control Group | Other | Device: Physical activity measurementThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity measurementTo 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 | Control Group, Visual Feedback |
| Visual FeedbackThe 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. | Device | Visual Feedback |
Primary outcome
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
7 secondary outcomes
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
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
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
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
Length of stay
Time frame: Time from hospital admission to hospital discharge
Readmission to hospital
Time frame: within 90 days
In-hospital fall incidents
Time frame: Through hospital stay, on average between 1 and 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Derived from this study: PubMed 42378437Dall CH, Gunnarsson DV, Suetta C, Pedersen L, Prescott E, Henriksen M. Technology-assisted physical activity among hospitalized medical patients: a cluster randomized trial. Eur J Prev Cardiol. 2026 Jun 30:zwag210. doi: 10.1093/eurjpc/zwag210. Online ahead of print.
- Individual participant dataSharing planned: Yes. IPD can be shared upon request sen to the sponsor and/or invesitgators
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity measurement and Visual Feedback in people with Pulmonary Disease and Cardiac Disease, run by Marius Henriksen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04555330, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.