- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04103255
High Frequency and Intensive Prevention Program
High Frequency Multimodal Training Including Tai Chi for Improving Motor and Cognitive Function in People With Parkinson's Disease
Study Overview
Status
Conditions
Intervention / Treatment
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.
- 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/
- 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/.
- 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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Basel, Switzerland, 4031
- University Hospital Basel
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with idiopathic Parkinson syndrome according to United Kingdom Parkinson's Disease Brain Bank Criteria
- mental competence to provide informed consent
- able to understand German sufficiently
Exclusion Criteria:
- Severe dementia (DMS-IV, mini mental Status (MMS) <24, moca test (MoCa) <21)
- young onset Parkinson's disease (<18y)
- other neurological or psychiatric diseases of the brain not related to PD
- secondary parkinsonism
- physical impairment hindering the adequate execution of the training
- insufficient knowledge of German
- pregnancy
- Deep Brain Stimulation (DBS) is no exclusion criterion.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: High frequency and intensive prevention
High frequency and intensive prevention program
|
This study is a 4 week non-randomized controlled trial (RCT)
|
Active Comparator: Control group (CogniPlus)
Computer-assisted cognitive training program
|
This study is a 4 week non-randomized controlled trial (RCT)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Episodic memory: California Verbal Learning Test (CVLT; Delis, Kramer, Ober, & Kaplan, 1987)
Time Frame: Before and after 4 weeks of training, After 6-month
|
This is a method that tests memory functions, including encoding, retrieval, and recognition processes.
The task is to learn in five cycles a shopping list of 16 words assigned to four semantic categories (i.e.
beverages, fruits, clothing, tools).
As many words as possible should be enumerated after each cycle.
The sum of the words stored in the 1-5 cycles is used as the encoding parameter.
|
Before and after 4 weeks of training, After 6-month
|
working memory: Corsi Block Test (Härtig et al., 2000)
Time Frame: Before and after 4 weeks of training, After 6-month
|
Corsi Block Test serve to evaluate the verbal and visual working memory. In the Corsi Block, the test person is presented with a board with irregularly arranged cubes. The task is to remember a sequence of tapped cubes and then to tap the cubes in the same sequence or later to follow the path shown in reverse order. Also with this test the difficulty increases, as the offered sequences become increasingly longer. The total score for the Digit Span is the sum of 12 items, ranging from 0 (worst possible result) to 12 (best possible result). The total score for the Corsi Block is the sum of 14 points in forward typing, ranging from 0 (worst score) to 14 (best symptoms) and the sum of 12 points in backward typing from 0 (worst score) to 12 (best symptoms). |
Before and after 4 weeks of training, After 6-month
|
Visuo-construction: Rey-Osterrieth complex figure (Duley et al., 1993)
Time Frame: Before and after 4 weeks of training, After 6-month
|
The Rey-Osterrieth (ROCF) and Taylor (TCF) complex figure tests are widely used to assess visuospatial and constructional abilities as well as visual/non-verbal Memory (Marie-Pier Tremblay et al., 2015). The score ranging from 0 (worst possible result) to 36 (best possible result). · |
Before and after 4 weeks of training, After 6-month
|
Attention: Trail Making Test, part A (J. Perianez et al., 2007)
Time Frame: Before and after 4 weeks of training, After 6-month
|
Trail Making Test, part A serve to evaluate the attention
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Before and after 4 weeks of training, After 6-month
|
Executive function (flexibility): Wisconsin Card Sorting test, number of errors (H.E. Nelson, 1976)
Time Frame: Before and after 4 weeks of training, After 6-month
|
Wisconsin Card Sorting test serve to evaluate the executive function
|
Before and after 4 weeks of training, After 6-month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Electroencephalogram (EEG)
Time Frame: Before and after 4 weeks of training, After 6-month
|
|
Before and after 4 weeks of training, After 6-month
|
Near-infrared spectroscopy
Time Frame: Before and after 4 weeks of training, After 6-month
|
Detecting changes in blood hemoglobin concentrations associated with neural activity
|
Before and after 4 weeks of training, After 6-month
|
Unified Parkinson's Disease Rating Scale UPDRS Part III
Time Frame: Before and after 4 weeks of training, After 6-month
|
This is the standard scale used for grading severity of PD. (UPDRS) - Four Parts Higher score values represent a worse outcome. Part I: Mentation, Behavior and Mood - 4 questions 1-4 Score range: 1-16; Part II: Activities of Daily Living - 13 questions 5-17 Score range: 0-52 Part III: Motor Examination - 19 questions 18-31 and 25 total assessments Score range: 0-100 Part IV: Complications of Therapy (In the past week) - 11 questions Score range: 0-25 |
Before and after 4 weeks of training, After 6-month
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Tinetti Mobility Test (D.A. Kegelmeyer et al., 2007)
Time Frame: Before and after 4 weeks of training, After 6-month
|
Balance and stability assessment
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Before and after 4 weeks of training, After 6-month
|
Epworth Sleepiness Scale (M.W. Johns, 1991)
Time Frame: Before and after 4 weeks of training, After 6-month
|
Measuring Daytime Sleepiness
|
Before and after 4 weeks of training, After 6-month
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Peter Fuhr, Prof.Dr.med, University Hospital, Basel, Switzerland
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BSL prevention program
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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