Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04865627 |
| Other study ID # |
S64932 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 22, 2021 |
| Est. completion date |
May 1, 2022 |
Study information
| Verified date |
July 2022 |
| Source |
KU Leuven |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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 (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.
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.
