Trial document




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  DRKS00009384

Trial Description

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Title

Frailty prevalence in outpatient physical therapy clinics

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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 (Inouye 2007). It is a complex and multicausal state of vulnerability towards negative health outcomes after a stressor event (Clegg 2013).

The most established and most frequently recommended instruments to quantify (or diagnose) frailty are the frailty index (Mitnitski 2001) and the frailty phenotype (Fried 2001) ("gold standard") (Clegg 2013; Shamliyan 2013; Morley 2013; Vries 2011).

A systematic review of Shamliyan et al. (Shamliyan 2013) analysed 24 large scale epidemiological studies, including older people 65 years of age and older. Based on the definition of frailty, pooled prevelances were 24% (deficit accululation model) and 14% (phenotype model).

A significant proportion of people receiving physiotherapy interventions is older than 65 years. It can be assumed that the planning and application of treatement regimes used for older individuals with frailty need particular attention. Furthermore, the frailty syndrome has been proposed as an important area of activity for the physiotherapy profession (Braun 2014; Turner 2014; Fairhall 2011). The precise prevalence of people with frailty in the outpatient physiotherapy setting is unclear as there are no national or international studies fucussing on the number of people with frailty presenting to physiotherapy providers.

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Brief Summary in Scientific Language

Epidemiologal study to examinde the prevalence of the frailty syndrome in older people receiving physiotherapy.

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Organizational Data

  •   DRKS00009384
  •   2015/10/16
  •   [---]*
  •   yes
  •   Approved
  •   2015 – 07, Ethikkommission des Deutschen Verbandes für Physiotherapie an der Physio-Akademie Wremen
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Secondary IDs

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Health Condition or Problem studied

  •   R54 -  Senility
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Interventions/Observational Groups

  •   To ensure a preverably representative selection of study participants, the recruitement procedures will follow as described above:

    (1) The city of Bochum in Germany will be selected due to logistical reasons (closeness to the study centre / Hochschule für Gesundheit Bochum (hsg)).

    (2) Outpatient physiotherapy clinics/practices will be asked for study participantion based on a randomised, decending order. Clinics/practices will be included if: (1) At least 5 physiotherapists are working in the clinic, (2) the proportion of patients 65+ years of age is >20%, (3) there are spatial abilities in the clinic to perform the examinations required for this study.

    (3) Recruitement will be performed in those clinics that fulfill all inclusion criteria and that consent to participate. Research staff and/or therapists of the clinics will screen patients for inclusion and exclusion criteria.

    Frailty will be measured by means of the two most established tools: frailty phenotype (Fried's phenotype criteria) and the accumulation of deficit model (frailty index).

    Other individual-related data recorded will include: indication, frequency, number, and duration of the physiotherapy treatment regime; self rated health; PRISMA-7 frailty screening questionnaire.

    Study participants will be dichotomised into groups of "frail" and "non-frail/fit" individuals based on their frailty index or frailty phenotype score, respectively. The prevalence is the number of frail individuals devided by the total number of the sample (prevalence = number of affected individuals at the time of investigation / number of included individuals into the investigation).

    Prevalence estimated will be calculated according to both diagnostic models (frailty index and frailty phenotype) based on the whole sample, as well a subjected to sex-specific and age-related sub-groups: “young–old” as 65–79 years, “elderly” as 80–89 years, and “very old” as 90 or more years (Shamliyan 2013).
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Characteristics

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

Frailty prevalence estimations according to the diagnostic model (frailty phenotype /frailty index).

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Secondary Outcome

Sex-specific and age-related frailty prevelance estiamtions.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2015/10/26
  •   250
  •   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

(1) ≥65 years of age
(2) receiving physiotherapy treatments (prescription covered by the public or a private health insurance)

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Exclusion Criteria

(1) no voluntary participation
(2) language barriers (German)
(3) no time to participate in the study examination
(4) inability to understand the study information and to give written informed consent (eg due to severe aphasia, severe cognitive impairement/dementia, blindness)

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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 complete, follow-up complete
  •   2017/05/04
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.