Trial document




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  DRKS00007576

Trial Description

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Title

Mobility tests to screen for frailty: Validity in older nursing home residents

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Frailty is a geriatric syndrome. It describes a state of high vulnerability of older adults towards negative health events. A quantification of frailty is crucial to identify older individuals that have an increased risk of further functional decline.

Actually, the „Frailty Index“, and the „Frailty Phenotype“ are considered the „gold standard“ when it comes to frailty assessment [Fried 2001, Mitnitski 2001]. However, in clinical practice a fast screening of frailty is important. This procedure is recommended by an international consensus group [Morley 2013].

Since frailty is linked to physical functioning, simple mobility tests are potential screening instruments. Recent investigations are promising, but only a small variety of tests has been used in these trials [Gobbens 2014, Greene 2014, Kim 2010, Savva 2013, Tang 2014]. A psychometric examination, as well as a comparison between more measurement instruments as not been performed so far.

Thus, the aim of this study is to examine the validity of the following mobility instruments when they are used as frailty screening tools in older nursing home residents: De Morton Mobility Index (DEMMI), Hierarchical Assessment of Balance and Mobility (HABAM), Functional Ambulation Categories (FAC), Short Physical Performance Battery (SPPB), Timed Up And Go Test (TUG), Performance Oriented Mobility Assessment (POMA), 6 Minute Walk Test.

Those mobility instruments can serve as simple, standardized and fast frailty screening tools in clinical care.

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Brief Summary in Scientific Language

Diagnostic accuracy study.

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Organizational Data

  •   DRKS00007576
  •   2014/12/02
  •   [---]*
  •   yes
  •   Approved
  •   2014-07, Ethikkommission des Deutschen Verbandes für Physiotherapie
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Secondary IDs

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Health Condition or Problem studied

  •   frailty in older nursing home residents
  •   R54 -  Senility
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Interventions/Observational Groups

  •   Criterion validity:

    All participants will be examined with the index tests (measures of mobility: De Morton Mobility Index (DEMMI), Hierarchical Assessment of Balance and Mobility (HABAM), Functional Ambulation Categories (FAC), Short Physical Performance Battery (SPPB), Timed Up And Go Test (TUG), Performance Oriented Mobility Assessment (POMA), 6 Minute Walk Test).

    Presence of the frailty syndrome, as the reference test, will be defined based on results of the Frailty Phenotype [Fried 2001] and the Frailty Index [Mitnitski 2001].

    The diagnostic accuracy (area under the curve, sensitivity and specificity, positive / negative Predictive Value PPV, NPV) of each mobility assessments towards the frailty status will be calculated. The optimal cut-off values for each test will be defined by use of the method descriibed by Youden [Youden 1950].
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Criterion Validity: Sensitivity and Specificity of each mobility instrument (index test) with respect to frailty, as measured with the "Frailty Phenotype" (reference test).

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Secondary Outcome

Criterion Validity: Sensitivity and Specificity of each mobility instrument (index test) with respect to frailty, as measured with the "Frailty Index" (reference test).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Planned
  •   2014/12/08
  •   120
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   65   Years
  •   no maximum age
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Additional Inclusion Criteria

individuals living in a nursing home or senior residence or any other institution where some kind of care is provided

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Exclusion Criteria

1. Contraindication for mobilization
2. No consent for participation
3. Blindness
4. Deafness
5. German language skills that are not sufficient for comprehension of instructions
6. Insufficient ability to give informed consent (sufficient cognitive and verbal abilities, e.g. no severe dementia, no severe dysphasia, no severe aphasia)
7. Acute infections
8. Akute illness
9. Scheduling difficulties

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Addresses

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    • Hochschule für gesundheit, Bochum
    • Mr.  Prof. Dr.  Christian  Grüneberg 
    • Universitätsstr. 105
    • 44789  Bochum
    • Germany
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    • Hochschule für Gesundheit, Bochum
    • Mr.  M.Sc.  Tobias  Braun 
    • Universitätsstr. 105
    • 44789  Bochum
    • Germany
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    • Hochschule für Gesundheit, Bochum
    • Mr.  M.Sc.  Tobias  Braun 
    • Universitätsstr. 105
    • 44789  Bochum
    • Germany
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Sources of Monetary or Material Support

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    • Hochschule für Gesundheit
    • Universitätsstr. 105
    • 44789  Bochum
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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