NCT02089516

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2014

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 14, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 17, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

March 21, 2018

Status Verified

March 1, 2018

Enrollment Period

7 months

First QC Date

March 14, 2014

Last Update Submit

March 20, 2018

Conditions

Elderly

Keywords

FrailtyAccelerometryPhysical activityvalidity

Outcome Measures

Primary Outcomes (1)

  • Type of movement: lying, sitting/standing or walking

    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 Outcomes (1)

  • Movement intensity (METs)

    up to six hours

Study Arms (1)

Frail elderly

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

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Living in a nursing-home

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Woonzorgcentrum De Wissel

Zwolle, Overijssel, 8024 CS, Netherlands

Location

Woonzorgcentrum Westenhage

Zwolle, Overijssel, 8042AD, Netherlands

Location

Related Links

MeSH Terms

Conditions

FrailtyMotor Activity

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Kornelis van Hateren, MD PhD

    Isala, diabetes centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

March 14, 2014

First Posted

March 17, 2014

Study Start

February 1, 2014

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

March 21, 2018

Record last verified: 2018-03

Locations

NL(2)