Clinical trial NCT06403826: SHIFT Hospital in Motion (Pilot Study)
Official title: SHIFT Hospital in Motion - Explorative Single-centre Pilot Study for the Detectability of Movements by Means of Activity Sensor in Patients of an Acute Care Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hospitalized Patients
Physical Inactivity
Keywords: Movement detection
Activity sensors
Sensor positioning
Algorithm development
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Zurich University of Applied Sciences
First posted: 2024-05-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Acute hospitalized patients are continuously recruited by the project management team within the context of daily clinical practice from a surgical ward at the University Hospital Basel. Recruitment takes place as soon as possible after admission to the hospital.

Brief summary: The goal of this monocentric observational study involving acute hospitalised patients is to develop a classification algorithm for the detection of various movements parameters.

Detailed description: Patients in hospitals spend the majority of their time inactive, sitting or lying down. Not being active is a common problem for patients in hospitals, often causing complications and impairing recovery, as it can lead to issues such as reduced blood volume, unsteady blood pressure when standing, weaker muscles, and a higher risk of infections, blood clots, and other health issues. The inactivity-related changes in the body in combination with the natural ageing process, the stress of being in the hospital, a poor nutritional status, and possibly troubles with thinking, memory, and understanding or depression diminish the ability to regenerate with overall compromised physiological resilience.

In order to quantify the amount of physical activity of hospitalised patients, the ability of activity sensors to distinguish between lying, sitting, standing and walking is an important requirement.

The primary objective of this observational, single center study is to develop an algorithm for the detection of various movements parameters. Therefore, enrolled patients, wearing a sensor on either ankle, wrist, or upper thigh, perform a fixed set of movements to generate acceleration and movement data.

The secondary objective is the evaluation of the best suited position of wearing the sensor.

The results of this pilot study will provide information about the feasibility and effectiveness of using activity sensors in clinical settings and will advance healthcare by developing an algorithm that accurately determines the activity patterns of hospitalized patients, thereby enhancing monitoring and understanding of patient mobility in hospital settings.

Eligibility criteria: Inclusion Criteria:

* patient must have been able to walk before hospitalisation (with or without aids)
* patient must be cognitively able to follow instructions (if a cognitive assessment has been carried out, this cut-off value counts, if no assessment is available, no cognitive impairment is assumed)
* ≥ 18 years
* signed informed consent

Exclusion Criteria:

* patient unable to move prior to hospital admission
* prior inclusion in the study
* discharge on the same day
* inability or contraindications to participate in the study or to follow the study procedures, e.g. due to certain neurological disorders (such as Parkinsonism, hemiplegia, severe Multiple Sclerosis), speech problems, mental disorders, or cognitive impairments isolated patient (unable to complete the test battery completely)

Primary outcomes:
measure: Development of a classification algorithm for the detection of movements parameters
timeFrame: 5 days during hospitalization (up to 1 hour per day)
Secondary outcomes:
measure: Evaluation of best sensor positioning
timeFrame: 5 days during hospitalization (up to 6 hours per day)
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Universitiy Hospital Basel, Division of Internal Medicine
state: Basel-Stadt
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Joris Kirchberger
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Basel, Switzerland
name: Jens Eckstein, Prof. Dr. med.
role: STUDY_CHAIR
References: