Elderly Clinical Trial
Official title:
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.
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.
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