High Frequency and Intensive Prevention Program
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      The treatment of PD has made considerable advances in recent years with respect to drug
      therapies, as well as many new physiotherapy and drug-based methods, and there have also been
      great improvements in therapy thanks to deep brain stimulation. Cognitive rehabilitation has
      shown to be effective in PD (Abbruzzese et al., 2016), however, there has yet to be a major
      breakthrough in the treatment and prevention of PDD (Parkinson's Disease Dementia ). This is
      where the high frequency and intensive prevention described here comes into play.
    

Detailed description: 
      Cognitive decline is an important and common complication in Parkinson's Disease (PD);
      approximately 27% of non-demented PD patients have Mild Cognitive Impairment (MCI) (Litvan et
      al. 2012, Chaudhuri et al., 2011) and up to 80% develop PD dementia (PD-D) over the long term
      (Hely et al., 2005). Cognitive course in PD is heterogeneous and affects visuospatial,
      attentional, executive and memory function; studies report different cognitive subtypes and
      divergent patterns of cognitive decline (Kehagia et al., 2010; Litvan et al., 2011;
      Williams-Gray et al., 2007; Yarnall et al., 2014). Recently, models have been constructed to
      estimate individual risk for global cognitive impairment using a small set of predictor
      variables (Liu et al. 2017; Velseboer et al., 2016). These prediction algorithms were
      developed in large samples of PD patients and accurately forecast cognitive decline in both,
      patients with MCI and patients with PD-D and were successfully replicated in independent
      samples; a score with a predefined cut off point predicts dementia with high positive and
      negative predictive values (Liu et al., 2017).

      The primary aim of this study is the possible stabilization or delay of cognitive decline as
      well as the improvement of the quality of life of the patients. As secondary outcome, the
      change in symptoms associated with PD, will be investigated. Psychological states as
      depression and anxiety, as well as cognitive performance in different areas, for example
      attention and memory shall be investigated. Neurological symptoms, for example motor function
      and sleepiness, will also be assessed as secondary parameters and potentially confounding
      factors.

      This study is a 4 week non-randomized controlled trial with one intervention group (HIPP) and
      one control group (CogniPlus). Primary and secondary outcome measures are assessed at
      baseline and are repeated after the 4-week intervention period and at 6 month in a follow-up
      assessment. After 4 weeks there is an intermediate measurement consisting of the primary
      outcome measures.

      The intervention group receives individualized program: the program will be tailored to the
      patient's needs, strengths and weaknesses, resulting from the initial assessment.

        1. Tai Chi - "Keep Moving" is an exercise programme for patients with movement disorders
           that explicitly utilizes the health aspect of Tai Chi movement teachings. Each session
           lasted 60 minutes and ended with a 10-minute meditation. The Tai Chi sessions in our
           study were carried out twice a week under the guidance of certified Tai Chi instructors.
           Details of this program can be found on the following website:
           https://taiji-therapie.ch/

        2. CogniFit® - is a online-based personalized cognition training program. This
           well-validated cognitive training improves attention, working memory, memory, executive
           function, and visual perceptual functions. Each session lasted 20 minutes and was
           applied 2-5 times per week based on the results of the baseline tests. The home-based
           approach took place under the supervision of a psychologist or a specially trained
           psychology student. The difficulty level was automatically adjusted by the program
           itself. Details of the program can be found on the following website:
           https://www.cognifit.com/.

        3. SpeechCare - (MoveApp) is a home-based approach for patients with Parkinson's disease.
           The training program uses automatic speech recognition (ASR) and thus can provide
           feedback on speech intelligibility. Each session lasted 12 minutes and was conducted 1-3
           times per week based on the results of the baseline test of SpeechCare . The domestic
           approach took place under the supervision of a psychologist or a specially trained
           psychology student. The level of difficulty was manually adjusted as needed. Details of
           the program can be found on the following website: https://www.speechcare.de/.

      The patients in the control group received a computer-assisted cognitive training program:
      CogniPlus (Schuhfried GmbH, Vienna, Austria). Each training session consisted of different
      tasks (Focused attention; working memory; planning and action skill; respons inhibition) that
      were performed for 10 Minutes each. Details of the program can be found on the following
      website: www.schuhfried.at. The training sessions were supervised by a psychologist or a
      specially trained student of psychology
    

Intervention name(s): High frequency and intensive prevention program
Intervention type(s): Other
Intervention description(s): This study is a 4 week non-randomized controlled trial (RCT)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Cognition; Tai Chi