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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04120740
Other study ID # HH-SENS-FYS-01
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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