Hip FracturesNCT04120740
Validation of Two Acitivity Monitors in Three Inpatient Populations.
An observational study of Hip Fractures and Abdominal Surgery, run by Mette Merete Pedersen at 1 site in Denmark.
Trial summary
The aim of this study is to investigate the validity of Sens Motion and ActivPAL acitivity monitors. Thirthy-six patients from three different patient populations will be included: 12 acute high-risk abdominal surgery patients (+18 years), 12 hip fracture patients (+65) and 12 older medical patients (+65). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Fractures, Abdominal Surgery, Medical Patients
- How many people
- 36 participants
- Where
- 1 siteDenmark
- Study dates
- 10 Oct 2019to 18 Nov 2019
- Phase
- Observational
- 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
Study population: The study population will be a convenience sample based on eligible patients from different departments at Copenhagen University Hospital, Hvidovre: Hip fracture patients from the orthopaedic department, patients undergoing acute high-risk abdominal surgery from the department of gastrointestinal surgery, and medical patients from one of four medical departments. The patients will be selected based on the last four digits of their personal identification number.
Who may be able to join
- older medical patient (+65)
- older hip fracture patient (+65)
- acute high-risk abdominal surgery patient (+18)
- admitted from own home
Who cannot join
- inability to walk independently with or without a walking aid
- inability to transfer from lying to sitting and sitting to standing
- inability to cooperate
- inability to understand or speak Danish.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to investigate the validity of Sens Motion and ActivPAL acitivity monitors. Thirthy-six patients from three different patient populations will be included: 12 acute high-risk abdominal surgery patients (+18 years), 12 hip fracture patients (+65) and 12 older medical patients (+65).
Each patient will be asked to wear two sets of activity monitors while performing a predefined researcher-supervised protocol consisting of a range of positions and activities including lying down, sitting, standing and walking.
Observations measured by time in each position will be used as a golden standard for physical activity and thus compared with the data produced by the acitivity monitors.
Read the detailed description
The study will investigate the association between activity measured by Sens Motion and ActivPAL acitivity monitors, respectively, and direct observation in order to investigate to which degree the two types of activity monitors are able to classify activity (i.e. lying, sitting, standing, walking, up/down transitions and steps).
Thirty-six patients from three different patient populations will be included: 12 acute high-risk abdominal surgery patients (+18 years), 12 hip fracture patients (+65) and 12 older medical patients (+65). Inclusion criteria to be fullfilled: 1) admission from own home. Patients will be excluded for the following reasons: inability to walk independently with or without a walking aid; inability to transfer from lying to sitting, inability to transfer from sitting to standing, inability to cooperate, and inability to speak or understand Danish.
Each patient will be asked to wear two sets of activity monitors (on the right thigh and on the chest) while performing a predefined, supervised protocol consisting of a range of positions and activities including lying down, sitting, standing and walking.
- Conditions
- Hip Fractures, Abdominal Surgery, Medical Patients
- Keywords
- Validility, Activity moitoring
- Medical subject headings
- Hip Fractures
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement between classification of activity by activity monitors and direct observation
Agreement between classification of activity by activity monitors and direct observation for lying, sitting, standing, walking, up-down transitions and steps
Measured: Approximately 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2019
- Study start10 Oct 2019
- Primary completion18 Nov 2019
- Study completion18 Nov 2019
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 Hip FracturesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mette Merete Pedersen
- Sponsor type
- University, hospital or other
- Collaborators
- SENS Innovation Aps
- Responsible party
- Sponsor-investigator, Mette Merete Pedersen, Copenhagen University Hospital, Hvidovre
- Investigators
- Mette M Pedersen, Postdoc, Study chair, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04120740
- Sponsor's protocol ID
- HH-SENS-FYS-01
- Status last verified
- Nov 2019
- First submitted
- 8 Oct 2019
- Last updated
- 21 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pedersen BS, Kristensen MT, Josefsen CO, Lykkegaard KL, Jonsson LR, Pedersen MM. Validation of Two Activity Monitors in Slow and Fast Walking Hospitalized Patients. Rehabil Res Pract. 2022 May 16;2022:9230081. doi: 10.1155/2022/9230081. eCollection 2022.
PubMed 35615755
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Two Acitivity Monitors in Three Inpatient Populations.
- ClinicalTrials.gov ID
- NCT04120740
- Acronym / sponsor ID
- HH-SENS-FYS-01
- Conditions
- Hip Fractures, Abdominal Surgery, Medical Patients
- Keywords
- Validility, Activity moitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Mette Merete PedersenUniversity, hospital or other
- Collaborators
- SENS Innovation Aps
- Study start
- 10 Oct 2019 (actual)
- Primary completion
- 18 Nov 2019 (actual)
- Study completion
- 18 Nov 2019 (actual)
- First posted
- 9 Oct 2019 (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 the validity of Sens Motion and ActivPAL acitivity monitors. Thirthy-six patients from three different patient populations will be included: 12 acute high-risk abdominal surgery patients (+18 years), 12 hip fracture patients (+65) and 12 older medical patients (+65).
Each patient will be asked to wear two sets of activity monitors while performing a predefined researcher-supervised protocol consisting of a range of positions and activities including lying down, sitting, standing and walking.
Observations measured by time in each position will be used as a golden standard for physical activity and thus compared with the data produced by the acitivity monitors.
Detailed description
The study will investigate the association between activity measured by Sens Motion and ActivPAL acitivity monitors, respectively, and direct observation in order to investigate to which degree the two types of activity monitors are able to classify activity (i.e. lying, sitting, standing, walking, up/down transitions and steps).
Thirty-six patients from three different patient populations will be included: 12 acute high-risk abdominal surgery patients (+18 years), 12 hip fracture patients (+65) and 12 older medical patients (+65). Inclusion criteria to be fullfilled: 1) admission from own home. Patients will be excluded for the following reasons: inability to walk independently with or without a walking aid; inability to transfer from lying to sitting, inability to transfer from sitting to standing, inability to cooperate, and inability to speak or understand Danish.
Each patient will be asked to wear two sets of activity monitors (on the right thigh and on the chest) while performing a predefined, supervised protocol consisting of a range of positions and activities including lying down, sitting, standing and walking.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be a convenience sample based on eligible patients from different departments at Copenhagen University Hospital, Hvidovre: Hip fracture patients from the orthopaedic department, patients undergoing acute high-risk abdominal surgery from the department of gastrointestinal surgery, and medical patients from one of four medical departments. The patients will be selected based on the last four digits of their personal identification number.
Key inclusion criteria (4 listed)
- older medical patient (+65)
- older hip fracture patient (+65)
- acute high-risk abdominal surgery patient (+18)
- admitted from own home
Key exclusion criteria (4 listed)
- inability to walk independently with or without a walking aid
- inability to transfer from lying to sitting and sitting to standing
- inability to cooperate
- inability to understand or speak Danish.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Agreement between classification of activity by activity monitors and direct observation
Time frame: Approximately 20 minutes
Agreement between classification of activity by activity monitors and direct observation for lying, sitting, standing, walking, up-down transitions and steps
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 21 Nov 2019.
- Derived from this study: PubMed 35615755Pedersen BS, Kristensen MT, Josefsen CO, Lykkegaard KL, Jonsson LR, Pedersen MM. Validation of Two Activity Monitors in Slow and Fast Walking Hospitalized Patients. Rehabil Res Pract. 2022 May 16;2022:9230081. doi: 10.1155/2022/9230081. eCollection 2022.
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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.
Mette M Pedersen, Postdoc study chair
Hvidovre University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Fractures and Abdominal Surgery, run by Mette Merete Pedersen 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 4 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 21 Nov 2019. 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?
Agreement between classification of activity by activity monitors and direct observation (time frame: Approximately 20 minutes). 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 NCT04120740, 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 21 Nov 2019.