Respiratory DiseaseTAPASNCT03333850
Technology Assisted Physical Activity Among Hospitalised Patients With Respiratory Disease
A study testing Visual feedback of physical activity, No feedback of physical activity and Measurement of physical activity in people with Respiratory Disease, run by Marius Henriksen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Disease
- What is being tested?
- Visual feedback of physical activity, No feedback of physical activity and Measurement of physical activity
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteDenmark
- Study dates
- 8 Nov 2017to 30 Jun 2018
- 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
- Is admitted to the Department of Respiratory Medicine
- Has signed informed consent
- Reads and speaks Danish
Who cannot join
- Any condition that, in the opinion of the investigator, makes the person unfit for participation
- 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
Official title: Technology Assisted Physical Activity Among Hospitalised Patients With Respiratory Disease - a Controlled Cohort Study
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.
Read more
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
- Being tested
- Visual feedback of physical activity, No feedback of physical activity, Measurement of physical activity
- Medical subject headings
- Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual feedback of physical activityDevice
A monitor (tablet) will display the level of physical activity during hospitalisation. The monitor will be placed at the bedside (table).
No feedback of physical activityDevice
There will be no visual feedback of the physical activity (no monitor placed at the bedside (table)).
Measurement of physical activityDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: No feedback of physical activity; Device: Measurement of physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 Days
Secondary outcomes (3)
Time spent sitting during hospitalisation
Time (in minutes) spent sitting related to the total hospitalisation time. The time sitting will be recorded throughout the hospitalisation for a maximum of 7 days.
Measured: 7 Days
Time spent standing during hospitalisation
Time (in minutes) spent standing related to the total hospitalisation time. The time standing will be recorded throughout the hospitalisation for a maximum of 7 days.
Measured: 7 Days
Time spent walking during hospitalisation
Time (in minutes) spent walking related to the total hospitalisation time. The time walking will be recorded throughout the hospitalisation for a maximum of 7 days.
Measured: 7 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2017
- Study start8 Nov 2017
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marius Henriksen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marius Henriksen, Frederiksberg University Hospital
- Investigators
- Christian H Dall, PhD, Study director, Department of Physio- and Occupational Therapy, Bispebjerg-Frederiksberg Hospital, DenmarkMarius Henriksen, PhD, Principal investigator, Department of Physio- and Occupational Therapy, Bispebjerg-Frederiksberg Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03333850
- Sponsor's protocol ID
- FYS010
- Acronym
- TAPAS
- Status last verified
- Dec 2018
- First submitted
- 30 Oct 2017
- Last updated
- 7 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: When data has been anonymised, analysed, and the scientific report(s) published, the data will be made available to other researchers. Availability will be through direct contact to the study director or principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology Assisted Physical Activity Among Hospitalised Patients With Respiratory Disease - a Controlled Cohort Study
- ClinicalTrials.gov ID
- NCT03333850
- Acronym / sponsor ID
- TAPAS / FYS010
- Conditions
- Respiratory Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Marius HenriksenUniversity, hospital or other
- Study start
- 8 Nov 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 7 Nov 2017 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Visual feedback of physical activity | Experimental | Device: Visual feedback of physical activity, Device: Measurement of physical activityParticipants 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. |
| No feedback of physical activity | Active comparator | Device: No feedback of physical activity, Device: Measurement of physical activityThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Is admitted to the Department of Respiratory Medicine
- Has signed informed consent
- Reads and speaks Danish
Key exclusion criteria (2 listed)
- Any condition that, in the opinion of the investigator, makes the person unfit for participation
- Has allergy towards band aid
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 |
|---|---|---|
| Visual feedback of physical activityA monitor (tablet) will display the level of physical activity during hospitalisation. The monitor will be placed at the bedside (table). | Device | Visual feedback of physical activity |
| No feedback of physical activityThere will be no visual feedback of the physical activity (no monitor placed at the bedside (table)). | Device | No feedback of physical activity |
| Measurement of physical activityA 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. | Device | No feedback of physical activity, Visual feedback of physical activity |
Primary outcome
Time spent out of bed during hospitalisation
Time frame: 7 Days
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.
3 secondary outcomes
Time spent sitting during hospitalisation
Time frame: 7 Days
Time spent standing during hospitalisation
Time frame: 7 Days
Time spent walking during hospitalisation
Time frame: 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 7 Dec 2018.
- Individual participant dataSharing planned: Yes. When data has been anonymised, analysed, and the scientific report(s) published, the data will be made available to other researchers. Availability will be through direct contact to the study director or principal investigator.
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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.
Christian H Dall, PhD study director
Department of Physio- and Occupational Therapy, Bispebjerg-Frederiksberg Hospital, Denmark
Marius Henriksen, PhD principal investigator
Department of Physio- and Occupational Therapy, Bispebjerg-Frederiksberg Hospital, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visual feedback of physical activity, No feedback of physical activity and Measurement of physical activity in people with Respiratory 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 3 inclusion and 2 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 7 Dec 2018. 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 during hospitalisation (time frame: 7 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Dec 2018.