Trial document




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  DRKS00014957

Trial Description

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Title

Physical functioning, cognition and psychosocial well-being for elderly, multimorbid nursing home residents

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Trial Acronym

PROCARE

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URL of the Trial

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Brief Summary in Lay Language

The purpose of this multicenter study is to examine the efficacy of a preventive, multicomponent exercise intervention for nursing home residents.

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Brief Summary in Scientific Language

The purpose of this multicenter study is to examine the efficacy of a preventive, multicomponent exercise intervention for nursing home residents. A two-arm single-blinded randomized controlled trial will be conducted.

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Organizational Data

  •   DRKS00014957
  •   2018/10/09
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  •   yes
  •   Approved
  •   PV5762, Ethik-Kommission der Ärztekammer Hamburg
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Secondary IDs

  •   U1111-1220-5081 
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Health Condition or Problem studied

  •   R54 -  Senility
  •   Limitations in physical and cognitive functioning
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Interventions/Observational Groups

  •   The intervention group will meet for group-based exercise sessions containing physical function (strength, endurance, fall prevention, balance, flexibility) and motor cognitive (dual task) exercises twice a week (45-60 minutes each session) for 16 weeks. Physical functioning, cognitive performance and quality of life/social engagement will be assessed at baseline (pre-test), at 16-weeks (post-treatment) and at 32-weeks (retention test, intervention group only) of the program.
  •   A waitlist-control group gets the intervention after a waiting period of 16 weeks. Physical functioning, cognitive performance and quality of life/social engagement will be assessed at baseline (pre-test) and after 16-weeks (post-test).
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   caregiver, assessor, data analyst
  •   Control group receives no treatment
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Motor and cognitive performance as well as psychosocial well-being will be assessed at baseline (pre-test), at 16-weeks (post-treatment) and at 32-weeks (retention test, intervention group only) of the program.
Gait performance will be assessed measuring step length, step width, gait speed, and double support phase. The Serial Sevens Test for cognitive functioning will be tested during a single- and dual-task condition. The Verbal Fluency Test is an additional test for cognitive functioning. The Satisfaction with Life Scale is used as an instrument to measure global cognitive judgments of satisfaction with one's life.
The Short Physical Performance Battery is a standardized instrument to test the functionality of lower extremity. The SF12 will be used to examine the health-related participants’ quality of life

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Secondary Outcome

Barthel Index is used for the recording of independence in performing basic activities of daily living. The Esslinger Transfer Scale is an instrument to determine the level of assistance during a transfer. Hand grip strength is measured with a hand dynamometer. Frailty will be measured using five factors: shrinking, weakness, exhaustion, slowness and physical activity. The Montreal Cognitive Assessment is used to reveal cognitive impairment. The Falls Efficacy Scale-International is a questionnaire to predict future falls, physiological fall risk, frailty, impairment and depressive symptoms. The Center of Epidemiological Studies-Depression Scale is used to screen mood disorders. The functional reach is a clinical measure of balance.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
  • other 
  • other 
  • other 
  • other 
  • other 
  • other 
  • other 
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Recruitment

  •   Actual
  •   2018/11/01
  •   1120
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

Personally expressed will to participate in this study, the ability to group activity, the ability to sit freely on a chair or a wheelchair, and the ability to understand and execute simple instructions.

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Exclusion Criteria

Unable to sit freely on a chair or a wheelchair. Unable to understand and execute simple instructions. Not interested.

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Addresses

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    • Universität Hamburg Institut für Bewegungswissenschaft Arbeitsbereich Gesundheitswissenschaften
    • Ms.  Dr  Bettina  Wollesen 
    • Mollerstr. 10
    • 20148  Hamburg
    • Germany
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    • Universität Paderborn Fakultät für Naturwissenschaften Department Sport & Gesundheit Arbeitsbereich Psychologie und Bewegung
    • Mr.  Prof  Matthias  Weigelt 
    • Warburger Str 100
    • 33098  Paderborn
    • Germany
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    • Technische Universität Chemnitz Fakultät für Human- und Sozialwissenschaften Institut für Angewandte Bewegungswissenschaften Professur Sportpsychologie
    • Ms.  Prof  Claudia  Voelcker-Rehage 
    • Thüringer Weg 11
    • 09126  Chemnitz
    • Germany
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    • Universität Stuttgart Institut für Sport- und Bewegungswissenschaft Lehrstuhl Sportpsychologie und Bewegungswissenschaften
    • Ms.  Prof  Nadja  Schott 
    • Allmandring 28
    • 70569  Stuttgart
    • Germany
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    • Karlsruher Institut für Technologie Institut für Sport und Sportwissenschaft
    • Ms.  Dr  Claudia  Hildebrand 
    • Engler-Bunte-Ring 15
    • 76131  Karlsruhe
    • Germany
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    • Friedrich-Alexander-Universität Erlangen-Nürnberg Institut für Medizinische Physik
    • Mr.  Dr  Daniel  Schöne 
    • Henkestr. 92
    • 91052  Erlangen
    • Germany
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    • Goethe Universität Frankfurt am Main Institut für SportwissenschaftenAbteilung Sportmedizin
    • Mr.  Prof  Lutz  Vogt 
    • Ginnheimer Landstr. 39
    • 60487  Frankfurt
    • Germany
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    • Universität Hamburg, Institut für Bewegungswissenschaft, Arbeitsbereich Gesundheitswissenschaften
    • Ms.  Dr  Bettina  Wollesen 
    • Mollerstr. 10
    • 20148  Hamburg
    • Germany
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    • Universität Hamburg Institut für Bewegungswissenschaft Arbeitsbereich Gesundheitswissenschaften
    • Ms.  Dr  Bettina  Wollesen 
    • Mollerstr. 10
    • 20148  Hamburg
    • Germany
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Sources of Monetary or Material Support

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    • Techniker Krankenkasse Hamburg
    • Ms.  Ursula  Meller 
    • Bramfelder Straße 140
    • 22305  Hamburg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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