Trial document




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  DRKS00005293

Trial Description

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Title

Comparison of different intervention programs to improve sensorimotor and cognitive performance of multi-morbid elderly patients

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Trial Acronym

KLaR

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Multi-morbidity refers to the presence of several chronic diseases. This state is very common among elderly subjects, especially those living in nursing homes. There are only a few studies investigating effective measures for the improvement of performance in these population.
In the present study, the effectiveness of a new program based on yoga exercises ("KLaR"), will be compared to well-known exercise programs ("Walking") and a passive control (unchanged lifestyle). The 90 participants aged 60-90 years live in residential care facilities of the German Red Cross (DRK) in Germany. Before and after the intervention period of 8 weeks (5 times a week for 45 minutes) all study participants are examined for their physical and mental abilities and their emotional well-being.
The study results should provide information on whether the program KLaR might be used to improve physical and mental performance in elderly multi-morbid residents.

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Brief Summary in Scientific Language

In this controlled study we investigate the impact of a yoga-based intervention program ("KLaR") on the physical and mental constitution of multi-morbid elderly subjects.
Due to the increasing life expectancy of the population of western industrialized nations there will be an increase of multi-morbid patients and thus also to a need to investigate multi-morbidity per se and to explore measures to improve the situation of these patients. Due to the complex and heterogeneous characterization of multi-morbidity few interventions are known so far that can be used to develop measures for the amelioration of objective constitution and subjective well-being.
In the planned longitudinal intervention study, 3 groups (N = 90, age-and gender-matched) of multi-morbid elderly residents (60-90 years) of nursing homes will be investigated using a cognitive, psychological and sensorimotor assessments before and after an 8-week intervention period. In the target group an Yoga-based intervention ("KLaR") will be used (5 times a week 45-minutes), whereas in the active control group, Walking training session will be performed and no intervention is done in the passive control group.

The aim of this study is to evaluate the effectiveness of the KLaR program to drive changes in objective and subjective situation of multi-morbid elderly home residents, and compare these results to conventional forms of therapeutic intervention.

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Organizational Data

  •   DRKS00005293
  •   2013/09/11
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  •   yes
  •   Approved
  •   4721-13, Ethik-Kommission der Medizinischen Fakultät der Ruhr-Universität Bochum
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Secondary IDs

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Health Condition or Problem studied

  •   Multimorbidity
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Interventions/Observational Groups

  •   Target group: 30 multi-morbid (two or more chronic diseases) elderly subjects (60-90 years) living in nursing care facilities will participate in a Yoga-based intervention program (KLaR) for 8 weeks (5 times a week for 45 minutes).
  •   Active control group: 30 multi-morbid (two or more chronic diseases) elderly subjects (60-90 years) living in nursing care facilities will participate in a intervention program (Walking) for 8 weeks (5 times a week for 45 minutes).
  •   Passive control group: 30 multi-morbid (two or more chronic diseases) elderly subjects (60-90 years) living in nursing care facilities will not participate in any intervention programs but continue their typical lifestyle for 8 weeks.
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control, No treatment
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Behavioural tests (A: one day before start of the intervention / B: One day after end of the intervention) to assess:
Constitution (Grip-strenght with hand dynamometer, walking performance in timed up&go test, stabilometry using STABLE)
Cognition (MMSE Dementia screening, Concentration test AKT) and
Sensorimotor performance (proprioception testing using a goniometer, reaction times using a custom-made setup, Somnowatch based actigraphy).

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Secondary Outcome

Interviews and questionnaires (A: one day before start of the intervention / B: One day after end of the intervention) with the subjects to assess: individual well-being (VAS-based pain rating, life-contentment questionnaire FLZ, health situation using the SF8). Interviews and questionnaires with the nurses to rate the subject's constitution (Barthel index, Beltztest scales to rate everyday-life performance).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
  • other 
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Recruitment

  •   Actual
  •   2013/09/16
  •   90
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   60   Years
  •   90   Years
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Additional Inclusion Criteria

Ability to decide independently about study participation.
Multi-morbidity (i.e. the presence of 2 or more chronic diseases).
Clinically stable situation.
Permanent residence in a nursing facility for at least 3 years.
Age 60-90 years.
Ability to carry out at least 2/3 of the used testing procedures
Minimum of standing and walking ability (even with crutches).

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Exclusion Criteria

Palliative care situation.
Severe loss of vision or hearing that can not be compensated.
Bad understanding of German language.
Aphasia, which prevents an informed consent.
Permanent confinement to bed.

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Addresses

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    • Deutsches Rotes Kreuz, Berlin Generalsekretariat
 Team 42-Altenhilfe und Gesundheitsförderung

    • Ms.  Dr.  Beate  Groß 
    • Carstennstraße 58
    • 12205  Berlin
    • Germany
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    • Neural Plasticity Lab, Institut für Neuroinformatik der Ruhr-Universität Bochum
    • Mr.  Dr.  Jan-Christoph  Kattenstroth 
    • Universtitätsstr. 150
    • 44780  Bochum
    • Germany
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    • Neural Plasticity Lab, Institut für Neuroinformatik der Ruhr-Universität Bochum
    • Mr.  Dr.  Jan-Christoph  Kattenstroth 
    • Universtitätsstr. 150
    • 44780  Bochum
    • Germany
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Sources of Monetary or Material Support

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    • Deutsches Rotes Kreuz, BerlinGeneralsekretariat
 Team 42 - Altenhilfe und Gesundheitsförderung

    • Ms.  Dr.  Beate  Groß 
    • Carstennstraße 58
    • 12205  Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2013/11/29
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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.