Activity Monitoring in Frail Elderly Patients

March 20, 2018 updated by: Henk Bilo, MD, Medical Research Foundation, The Netherlands

Activity Monitoring in Frail Elderly Patients. A Methods Comparison Study.

The purpose of this stuydy is to assess the bias and repeatability of the DynaPort MicroMod in measuring movement / physical activity in frail elderly.

Study Overview

Status

Completed

Conditions

Detailed Description

Elderly subjects will be recruited from a residential-care complex in Zwolle, the Netherlands. All subjects will be asked to fill in the Groningen Frailty Index. We aim to select patients with varying GFI scores to ensure that we include patients with different degrees of frailty. The participating subjects will be asked to wear the DynaPort MicroMod during six hours. Two research employees will observe all activities of the participating subjects in their home environment. The participant will be instructed to act like it is a normal/usual day. Every 5 minutes the type of activity at that moment and movement intensity of the last 5 minutes (METs scale) is manually entered onto a case report form (CRF) by the two employees. The timing has to be exact in order to compare the data to the data of the DynaPort MicroMod. Type of activity is described as well as categorised into lying, sitting, standing or walking. Movement intensity is categorised according to a MET-value (Metabolic Equivalent of Task).

Sensitivity, specificity, and percentage of overall agreement will be calculated for each type of activity (standing, sitting, lying, walking) and for intensity. The primary analysis will be the comparison between walking and not walking (lying, sitting or standing). An overall agreement/sensitivity/specificity of 90% or higher is considered as sufficient agreement. The Bland and Altman method will also be used as multiple observations are recorded per patient, the limits of agreement will also be calculated with the Bland and Altman method for repeated measures.

Study Type

Observational

Enrollment (Actual)

18

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Overijssel
      • Zwolle, Overijssel, Netherlands, 8024 CS
        • Woonzorgcentrum De Wissel
      • Zwolle, Overijssel, Netherlands, 8042AD
        • Woonzorgcentrum Westenhage

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Home-dwelling frail elderly (GFI score ≥ 4) of 75 years and older.

Description

Inclusion Criteria:

  • Age: 75 years and older
  • Frailty: GFI (Groningen Frailty Index) score ≥ 4

Exclusion Criteria:

  • Living in a nursing-home

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Frail elderly
Measuring movement activity in frail elderly (GFI score ≥ 4) of 75 years and older using DynaPort.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Type of movement: lying, sitting/standing or walking
Time Frame: up to six hours
The participating subjects will be asked to wear the DynaPort MicroMod during six hours. Two research employees will observe all activities of the participating subjects in their home environment. Every 5 minutes the type of activity at that moment is manually entered onto a case report form (CRF) by the two research employees.
up to six hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Movement intensity (METs)
Time Frame: up to six hours
The participating subjects will be asked to wear the DynaPort MicroMod during six hours. Two research employees will observe all activities of the participating subjects in their home environment. Every 5 minutes the movement intensity of the last 5 minutes (METs scale) is manually entered onto a case report form (CRF) by the two employees.
up to six hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical Research Foundation, The Netherlands

Investigators

  • Principal Investigator: Kornelis van Hateren, MD PhD, Isala, Diabetes Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

March 14, 2014

First Submitted That Met QC Criteria

March 14, 2014

First Posted (Estimate)

March 17, 2014

Study Record Updates

Last Update Posted (Actual)

March 21, 2018

Last Update Submitted That Met QC Criteria

March 20, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DynaPort I

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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