SHIFT-Hospital in Motion (Validation Study)

NCT ID: NCT06396676

Last Updated: 2024-07-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 101 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-04-29
• Study Completion Date: 2024-07-22

Brief Summary

The goal of this monocentric observational study involving acute hospitalised patients is to validate the accuracy of classification algorithms 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. A pilot study (NCT06403826) involving 40 patients examined the feasibility and effectiveness of using activity sensors in clinical settings. The study focused on detecting specific activities and movement patterns using sensors worn on various body parts, with the ankle identified as the preferred location for long-term monitoring. Most participants found wearing the sensors tolerable, indicating the practicality of this approach for extended patient activity monitoring.

The primary objective of this observational, single center study is to validate the accuracy of newly developed algorithms for the detection of various movements parameters. Two different sensors worn on the ankle are used to record the duration of lying, sitting/standing, and the number of steps taken when walking and climbing stairs (up/down). The validation is based on the movement data collected from this and the pilot study and will be conducted in two phases:

• phase 1 (model improvement): Increasing the robustness of the algorithms using training data
• phase 2 (model validation): Validation of the algorithms using test data

The secondary objectives are:

• to determine if altitude data enhances the algorithms' accuracy in distinguishing between stair climbing and walking
• to evaluate the comfort of wearing the sensors

The results of this study 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.

Conditions

Hospitalized Patients; Physical Inactivity

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zurich University of Applied Sciences

OTHER

Sponsor Role: collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joris Kirchberger

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Jens Eckstein, Prof. Dr. med.

Role: STUDY_CHAIR

University Hospital, Basel, Switzerland

Locations

Universitiy Hospital Basel, Division of Internal Medicine

Basel, Canton of Basel-City, Switzerland

Countries

Switzerland

Other Identifiers

2024-00594; am24Eckstein

Identifier Type: -

Identifier Source: org_study_id