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Activity Monitoring in Frail Elderly Patients

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ClinicalTrials.gov Identifier: NCT02089516
Recruitment Status : Completed
First Posted : March 17, 2014
Last Update Posted : March 21, 2018
Sponsor:
Information provided by (Responsible Party):
Henk Bilo, MD, Medical Research Foundation, The Netherlands

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

Condition or disease
Elderly

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.


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Study Type : Observational
Actual Enrollment : 18 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Activity Monitoring in Frail Elderly Patients. A Methods Comparison Study.
Study Start Date : February 2014
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

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



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Home-dwelling frail elderly (GFI score ≥ 4) of 75 years and older.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Living in a nursing-home

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02089516


Locations
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Netherlands
Woonzorgcentrum De Wissel
Zwolle, Overijssel, Netherlands, 8024 CS
Woonzorgcentrum Westenhage
Zwolle, Overijssel, Netherlands, 8042AD
Sponsors and Collaborators
Medical Research Foundation, The Netherlands
Investigators
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Principal Investigator: Kornelis van Hateren, MD PhD Isala, diabetes centre

Additional Information:
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Responsible Party: Henk Bilo, MD, MD PhD, Medical Research Foundation, The Netherlands
ClinicalTrials.gov Identifier: NCT02089516     History of Changes
Other Study ID Numbers: DynaPort I
First Posted: March 17, 2014    Key Record Dates
Last Update Posted: March 21, 2018
Last Verified: March 2018

Keywords provided by Henk Bilo, MD, Medical Research Foundation, The Netherlands:
Frailty
Accelerometry
Physical activity
validity