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OpenTrials
Completed

NCT Number: NCT04120740

Validation of Two Acitivity Monitors in Three Inpatient Populations.

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Copenhagen University Hospital, Hvidovre

Hvidovre, 2650, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Mette Merete Pedersen

Other

Collaborators

  • SENS Innovation Aps

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Oct 9, 2019
Registry last updated
Nov 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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