Validation of Two Acitivity Monitors in Three Inpatient Populations.

Hip Fractures Clinical Trial

Official title:

Validation of Two Acitivity Monitors in Three Inpatient Populations.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04120740
• Other study ID #: HH-SENS-FYS-01
• Status: Completed
• Start date: October 10, 2019
• Est. completion date: November 18, 2019

Study information

• Verified date: November 2019
• Source: Copenhagen University Hospital, Hvidovre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study is to investigate the validity of Sens Motion and ActivPAL acitivity monitors. Thirthy-six patients from three different patient populations will be included: 12 acute high-risk abdominal surgery patients (+18 years), 12 hip fracture patients (+65) and 12 older medical patients (+65).

Each patient will be asked to wear two sets of activity monitors while performing a predefined researcher-supervised protocol consisting of a range of positions and activities including lying down, sitting, standing and walking.

Observations measured by time in each position will be used as a golden standard for physical activity and thus compared with the data produced by the acitivity monitors.

Description:

The study will investigate the association between activity measured by Sens Motion and ActivPAL acitivity monitors, respectively, and direct observation in order to investigate to which degree the two types of activity monitors are able to classify activity (i.e. lying, sitting, standing, walking, up/down transitions and steps).

Thirty-six patients from three different patient populations will be included: 12 acute high-risk abdominal surgery patients (+18 years), 12 hip fracture patients (+65) and 12 older medical patients (+65). Inclusion criteria to be fullfilled: 1) admission from own home. Patients will be excluded for the following reasons: inability to walk independently with or without a walking aid; inability to transfer from lying to sitting, inability to transfer from sitting to standing, inability to cooperate, and inability to speak or understand Danish.

Each patient will be asked to wear two sets of activity monitors (on the right thigh and on the chest) while performing a predefined, supervised protocol consisting of a range of positions and activities including lying down, sitting, standing and walking.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: November 18, 2019
• Est. primary completion date: November 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• older medical patient (+65)

• older hip fracture patient (+65)

• acute high-risk abdominal surgery patient (+18)

• admitted from own home

Exclusion Criteria:

• inability to walk independently with or without a walking aid

• inability to transfer from lying to sitting and sitting to standing

• inability to cooperate

• inability to understand or speak Danish.

Related Conditions & MeSH terms

• Abdominal Surgery
• Hip Fractures
• Medical Patients

Locations

Country	Name	City	State
Denmark	Copenhagen University Hospital, Hvidovre	Hvidovre

Sponsors (2)

Lead Sponsor	Collaborator
Mette Merete Pedersen	SENS Innovation Aps

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Agreement between classification of activity by activity monitors and direct observation	Agreement between classification of activity by activity monitors and direct observation for lying, sitting, standing, walking, up-down transitions and steps	Approximately 20 minutes