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.

Study Overview

• Status: Completed
• Conditions: Hip Fractures; Abdominal Surgery; Medical Patients

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.

• Study Type: Observational
• Enrollment (Actual): 36

Contacts and Locations

Study Locations

• Denmark
  • Hvidovre, Denmark, 2650
    • Copenhagen University Hospital, Hvidovre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population will be a convenience sample based on eligible patients from different departments at Copenhagen University Hospital, Hvidovre: Hip fracture patients from the orthopaedic department, patients undergoing acute high-risk abdominal surgery from the department of gastrointestinal surgery, and medical patients from one of four medical departments. The patients will be selected based on the last four digits of their personal identification number.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Mette Merete Pedersen
• Collaborators: SENS Innovation Aps
• Investigators: Study Chair: Mette M Pedersen, Postdoc, Hvidovre University Hospital

Publications and helpful links

General Publications

• Pedersen BS, Kristensen MT, Josefsen CO, Lykkegaard KL, Jonsson LR, Pedersen MM. Validation of Two Activity Monitors in Slow and Fast Walking Hospitalized Patients. Rehabil Res Pract. 2022 May 16;2022:9230081. doi: 10.1155/2022/9230081. eCollection 2022.

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2019
• Primary Completion (Actual): November 18, 2019
• Study Completion (Actual): November 18, 2019

Study Registration Dates

• First Submitted: October 8, 2019
• First Submitted That Met QC Criteria: October 8, 2019
• First Posted (Actual): October 9, 2019

Study Record Updates

• Last Update Posted (Actual): November 21, 2019
• Last Update Submitted That Met QC Criteria: November 20, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Validility; Activity moitoring
• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Hip Fractures
• Other Study ID Numbers: HH-SENS-FYS-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No