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Completed

NCT Number: NCT02089516

Activity Monitoring in Frail Elderly Patients

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

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Key information

Age range

75 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Woonzorgcentrum De Wissel, Zwolle, Overijssel, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • Living in a nursing-home

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Medical Research Foundation, The Netherlands

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Mar 17, 2014
Registry last updated
Mar 21, 2018

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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