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Clinical Trials/NCT04120740
NCT04120740
Completed
Not Applicable

Validation of Two Acitivity Monitors in Three Inpatient Populations.

Mette Merete Pedersen1 site in 1 country36 target enrollmentOctober 10, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hip Fractures
Sponsor
Mette Merete Pedersen
Enrollment
36
Locations
1
Primary Endpoint
Agreement between classification of activity by activity monitors and direct observation
Status
Completed
Last Updated
6 years ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
October 10, 2019
End Date
November 18, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Mette Merete Pedersen
Responsible Party
Sponsor Investigator
Principal Investigator

Mette Merete Pedersen

Postdoctoral fellow

Copenhagen University Hospital, Hvidovre

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Agreement between classification of activity by activity monitors and direct observation

Time Frame: Approximately 20 minutes

Agreement between classification of activity by activity monitors and direct observation for lying, sitting, standing, walking, up-down transitions and steps

Study Sites (1)

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