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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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date May 1, 2022
Est. primary completion date May 1, 2022
Accepts healthy volunteers No
Gender All
Age group 70 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
activity monitor
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.

Locations

Country Name City State
Belgium Universitaire Ziekenhuizen Leuven Leuven

Sponsors (2)

Lead Sponsor Collaborator
KU Leuven Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary accuracy of the activity monitors compared to the observation accuracy of the activity monitors during the observation moment, second by second 30 minutes
Secondary usability of an activity monitor in daily practice on the ward Short questionnaire to explore the usability of the activity monitors one week
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