NCT04120740

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 8, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 9, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

October 10, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 18, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 18, 2019

Completed
Last Updated

November 21, 2019

Status Verified

November 1, 2019

Enrollment Period

1 month

First QC Date

October 8, 2019

Last Update Submit

November 20, 2019

Conditions

Keywords

ValidilityActivity moitoring

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • older medical patient (+65)
  • older hip fracture patient (+65)
  • acute high-risk abdominal surgery patient (+18)
  • admitted from own home

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Copenhagen University Hospital, Hvidovre

Hvidovre, 2650, Denmark

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Mette M Pedersen, Postdoc

    Hvidovre University Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Postdoctoral fellow

Study Record Dates

First Submitted

October 8, 2019

First Posted

October 9, 2019

Study Start

October 10, 2019

Primary Completion

November 18, 2019

Study Completion

November 18, 2019

Last Updated

November 21, 2019

Record last verified: 2019-11

Locations