High Frequency and Intensive Prevention Program

High Frequency and Intensive Prevention Program for Cognitive Stabilization and Improving of Quality of Life in Parkinson's Disease Patients

Recruitment Information:

Seeking volunteers with following diagnosis: Volunteers without Parkinson’s (controls) only Study Type: Interventional
Eligible Ages: 18 - 100 Status: Not yet recruiting
Time Since Diagnosis: Any may be eligible Study Focus:

Study Purpose:

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.

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More Details

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 randomized controlled trial (RCT) with one experimental intervention group and one control group (Stepped-wedge trial). 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. 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. Goal management training (Ariane Giguere-Rancourt et al., 2018) - is a home-based approach for PD patients with Mild Cognitive Impairment (MCI). The program will applied to High Risk Patients for PDD. This well-validated cognitive training is developed to improve executive functions. It helps patients to raise awareness of deficits and improve cognitive control in goal-directed behaviors. Each session last 75-90 minutes, one per week. 2. Physiotherapy - The role of physiotherapy is to maximize functional ability and minimize secondary complications through movement rehabilitation within a context of education and support for the whole person. The overall aim is to optimize independence, safety and well-being, thereby enhancing quality of life (Claire L Tomlinson et al., 2014). Physiotherapists train patients for example in cueing strategies to improve gait, strength to improve balance, motor co-ordination to improve posture and compensatory movement strategies to improve transfers (Samyra H.J. et al., 2004) The therapy sessions are individually guided by a physiotherapist and/or well-trained voluntarists at University Hospital of Basel (CH). Each session lasts 30 min, 1 to 3 per week. 3. Rhythmic Music Gymnastic - Music makes it easier for patients with PD to improve the sense of rhythm disturbed by the disease. Just listening to loud and rhythmic music leads to a measurable improvement in agility. In cooperation of music- und physiotherapy Beelitz music-gymnastics 1+2 has been developed: training schemes with music for a daily training program. The music has been composed in accordance with the Patterned Sensory Enhancement. Tune, chords and rhythm "depict" the movement in sound. By this movement and motivation are improved. (3) Each session lasts 60 min, 1 to 3 times a week. 4. Speech therapy -PD affects also face muscles, muscles in mouth and throat that are used to speak. This may cause a person's voice to change, as well as dysarthria, or difficulty in speaking, and dysphagia, or difficulty in swallowing. These problems may be referred to a speech and language therapist who is trained in all forms of communication, including non-verbal communication such as facial expressions or body language. Such therapists can teach techniques and offer tips for better communication. Each session lasts 60 min, 1 to 3 times a week. Control-group will obtain best medical treatment (Stepped-wedge trial).

Phase: N/A Lead Sponsor: University Hospital, Basel, Switzerland
Trial ID: 006484 Sponsor Type: Other
Primary Country: Switzerland Additional Collaborators or Sponsors: Parkinson Schweiz
Estimated Enrollment: 30 Study Start Date: October 2019
Estimated Study Completion Date: March 2021 Source: ClinicalTrials.gov
Study Website:

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