- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04865627
Accuracy Activity Monitors for Inhospital Activity Monitoring of Geriatric Patients
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Leuven, Belgium, 3000
- Universitaire Ziekenhuizen Leuven
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- medically unstable
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
independent walking with walking aid
the participant is able to walk with a walking aid and does not need further assistance.
|
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.
Other Names:
|
|
dependent walking with walking aid
the participant is able to walk with assistance and a walking aid
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
30 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
usability of an activity monitor in daily practice on the ward
Time Frame: one week
|
Short questionnaire to explore the usability of the activity monitors
|
one week
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Johan Flamaing, MD, PhD, UZ Leuven, KU Leuven
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- S64932
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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