Hip FracturesNCT04865627
Accuracy Activity Monitors for Inhospital Activity Monitoring of Geriatric Patients
An observational study of Hip Fractures and Stroke, run by KU Leuven at 1 site in Belgium.
Trial summary
The focus of this study will be to determine the accuracy of the MOX, the Axivity and Fitbit, Empatica and Chill+ activity monitors (with both custom-made and available algorithms) for the classification of lying, sitting, standing, walking and climbing stairs in hospitalized older people in Acute Care for the elderly… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Hip Fractures, Stroke, Abdominal Injury
- What is being tested?
- activity monitor
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 22 Mar 2021to 1 May 2022
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Participant are admitted to a geriatric ward in UZ Leuven, Belgium and use a walkingaid.
Who may be able to join
- admitted to the rehabilitation or acute ward of UZ Leuven
- walking with the use of a walkingaid
- a signed informed consent form
- an expected stay of at least 7 days
Who cannot join
- medically unstable
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Accuracy of Activity Monitors Based on Accelerometers and/or Multiple Sensors for the Objective Measurement of Physical Activity of Geriatric Patients During Hospitalization in Acute Care of Elderly (ACE) and Geriatric Rehabilitation Units
The focus of this study will be to determine the accuracy of the MOX, the Axivity and Fitbit, Empatica and Chill+ activity monitors (with both custom-made and available algorithms) for the classification of lying, sitting, standing, walking and climbing stairs in hospitalized older people in Acute Care for the elderly (ACE) and geriatric rehabilitation units.
In addition, the feasibility of the use of the activity monitors as a measurement tool in daily practice during hospitalization in the geriatric department will be investigated.
Read the detailed description
Adequate physical activity and exercise throughout the day are important to maximize independence and quality of life. To be able to optimize the physiotherapeutic interventions and to monitor how much geriatric patients move during hospitalization, it is desirable to follow up their activity by means of an activity monitor. In this study the investigators will determine the accuracy of three different types of activity monitors, the "MOX" placed on the thigh, the "Axivity" placed on the torso and the "Fitbit Sense", the "Empatica" and the "Chill+" placed on the wrist, for the classification of lying, sitting, standing, walking and climbing stairs in hospitalized older people in the geriatric department.
In this clinical study, 40 patients will participate of which 20 hospitalized in the geriatric rehabilitation unit at campus Pellenberg and 20 hospitalized in the acute care of elderly units at campus Gasthuisberg UZ Leuven, Belgium.
These activity monitors will remain attached for seven days so that activity can monitored during the week as well as on weekends. In an experimental test session a total of five activities (lying down, sitting, standing, walking and possibly climbing stairs) will be performed and observed, each lasting four minutes. The observations will be recorded by video where only the lower body will be in focus.
There will be daily checks to see if the activity monitors on the thigh, torso, and wrist stay in place, if the skin tolerates it well, if participants experiencing subjective discomfort, and if the measurements continue. At the end of the week, a short questionnaire will be completed on the user-friendliness of the different monitors.
The investigators will use the accuracy and patient satisfaction outcomes to decide the feasibility of using these activity monitors as a measurement tool in daily practice during hospitalization.
- Conditions
- Hip Fractures, Stroke, Abdominal Injury
- Being tested
- activity monitor
- Keywords
- geriatric inhospital rehabilitation, elderly, activity monitors
- Medical subject headings
- Hip Fractures, Stroke, Abdominal Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
activity monitorDevice
Also called accelerometer, activity sensor
Both groups will wear three different activity monitors for one week. There is one observation moment which consists of four minutes lying, sitting, standing, walking and taking stairs. Participants will be filmed during this moment.
| Study group | Role | What they receive |
|---|---|---|
| independent walking with walking aid | the participant is able to walk with a walking aid and does not need further assistance. Receives: Device: activity monitor | |
| dependent walking with walking aid | the participant is able to walk with assistance and a walking aid Receives: Device: activity monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
accuracy of the activity monitors compared to the observation
accuracy of the activity monitors during the observation moment, second by second
Measured: 30 minutes
Secondary outcomes (1)
usability of an activity monitor in daily practice on the ward
Short questionnaire to explore the usability of the activity monitors
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start22 Mar 2021
- Primary completion1 May 2022
- Study completion1 May 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 Hip FracturesStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven
- Responsible party
- Principal investigator, Margaretha van Dijk, KU Leuven
- Investigators
- Johan Flamaing, MD, PhD, Principal investigator, UZ Leuven, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04865627
- Sponsor's protocol ID
- S64932
- Status last verified
- Jul 2025
- First submitted
- 21 Apr 2021
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
van Dijk M, Bijnens W, Van Driessche C, Van Meerbeek T, Allegaert P, Van Cleynenbreugel H, Verschueren S, Verheyden G, Tournoy J, Flamaing J. Accuracy of an Activity Monitor in Assessing Physical Activity of Hospitalized Geriatric Rehabilitation Patients With Slow Walking Speed Using a Walking Aid. J Aging Phys Act. 2024 Nov 20;33(3):243-250. doi: 10.1123/japa.2023-0319. Print 2025 Jun 1.
PubMed 39566489
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Activity Monitors Based on Accelerometers and/or Multiple Sensors for the Objective Measurement of Physical Activity of Geriatric Patients During Hospitalization in Acute Care of Elderly (ACE) and Geriatric Rehabilitation Units
- ClinicalTrials.gov ID
- NCT04865627
- Acronym / sponsor ID
- S64932
- Conditions
- Hip Fractures, Stroke, Abdominal Injury
- Keywords
- geriatric inhospital rehabilitation, elderly, activity monitors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven
- Study start
- 22 Mar 2021 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 29 Apr 2021 (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 focus of this study will be to determine the accuracy of the MOX, the Axivity and Fitbit, Empatica and Chill+ activity monitors (with both custom-made and available algorithms) for the classification of lying, sitting, standing, walking and climbing stairs in hospitalized older people in Acute Care for the elderly (ACE) and geriatric rehabilitation units.
In addition, the feasibility of the use of the activity monitors as a measurement tool in daily practice during hospitalization in the geriatric department will be investigated.
Detailed description
Adequate physical activity and exercise throughout the day are important to maximize independence and quality of life. To be able to optimize the physiotherapeutic interventions and to monitor how much geriatric patients move during hospitalization, it is desirable to follow up their activity by means of an activity monitor. In this study the investigators will determine the accuracy of three different types of activity monitors, the "MOX" placed on the thigh, the "Axivity" placed on the torso and the "Fitbit Sense", the "Empatica" and the "Chill+" placed on the wrist, for the classification of lying, sitting, standing, walking and climbing stairs in hospitalized older people in the geriatric department.
In this clinical study, 40 patients will participate of which 20 hospitalized in the geriatric rehabilitation unit at campus Pellenberg and 20 hospitalized in the acute care of elderly units at campus Gasthuisberg UZ Leuven, Belgium.
These activity monitors will remain attached for seven days so that activity can monitored during the week as well as on weekends. In an experimental test session a total of five activities (lying down, sitting, standing, walking and possibly climbing stairs) will be performed and observed, each lasting four minutes. The observations will be recorded by video where only the lower body will be in focus.
There will be daily checks to see if the activity monitors on the thigh, torso, and wrist stay in place, if the skin tolerates it well, if participants experiencing subjective discomfort, and if the measurements continue. At the end of the week, a short questionnaire will be completed on the user-friendliness of the different monitors.
The investigators will use the accuracy and patient satisfaction outcomes to decide the feasibility of using these activity monitors as a measurement tool in daily practice during hospitalization.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| independent walking with walking aid | – | Device: activity monitorthe participant is able to walk with a walking aid and does not need further assistance. |
| dependent walking with walking aid | – | Device: activity monitorthe participant is able to walk with assistance and a walking aid |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Participant are admitted to a geriatric ward in UZ Leuven, Belgium and use a walkingaid.
Key inclusion criteria (4 listed)
- admitted to the rehabilitation or acute ward of UZ Leuven
- walking with the use of a walkingaid
- a signed informed consent form
- an expected stay of at least 7 days
Key exclusion criteria (1 listed)
- medically unstable
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 |
|---|---|---|
| activity monitorAlso: accelerometer, activity sensorBoth groups will wear three different activity monitors for one week. There is one observation moment which consists of four minutes lying, sitting, standing, walking and taking stairs. Participants will be filmed during this moment. | Device | dependent walking with walking aid, independent walking with walking aid |
Primary outcome
accuracy of the activity monitors compared to the observation
Time frame: 30 minutes
accuracy of the activity monitors during the observation moment, second by second
1 secondary outcome
usability of an activity monitor in daily practice on the ward
Time frame: one week
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 30 Jul 2025.
- Results publication: PubMed 39566489van Dijk M, Bijnens W, Van Driessche C, Van Meerbeek T, Allegaert P, Van Cleynenbreugel H, Verschueren S, Verheyden G, Tournoy J, Flamaing J. Accuracy of an Activity Monitor in Assessing Physical Activity of Hospitalized Geriatric Rehabilitation Patients With Slow Walking Speed Using a Walking Aid. J Aging Phys Act. 2024 Nov 20;33(3):243-250. doi: 10.1123/japa.2023-0319. Print 2025 Jun 1.
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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.
Johan Flamaing, MD, PhD principal investigator
UZ Leuven, KU Leuven
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 Stroke, run by KU Leuven at 1 site in Belgium.
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 1 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 30 Jul 2025. 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 Belgium. 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?
accuracy of the activity monitors compared to the observation (time frame: 30 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 NCT04865627, 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 30 Jul 2025.