High Frequency and Intensive Prevention Program

NCT04103255 | Completed

• 1 other identifier: BSL prevention program
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson Disease

Keywords

Cognition; Tai Chi

Outcome Measures

Primary Outcomes (5)

• Episodic memory: California Verbal Learning Test (CVLT; Delis, Kramer, Ober, & Kaplan, 1987)

  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)

  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)

  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)

  Trail Making Test, part A serve to evaluate the attention

  Before and after 4 weeks of training, After 6-month

• Executive function (flexibility): Wisconsin Card Sorting test, number of errors (H.E. Nelson, 1976)

  Wisconsin Card Sorting test serve to evaluate the executive function

  Before and after 4 weeks of training, After 6-month

Secondary Outcomes (5)

• Electroencephalogram (EEG)

  Before and after 4 weeks of training, After 6-month

• Near-infrared spectroscopy

  Before and after 4 weeks of training, After 6-month

• Unified Parkinson's Disease Rating Scale UPDRS Part III

  Before and after 4 weeks of training, After 6-month

• Tinetti Mobility Test (D.A. Kegelmeyer et al., 2007)

  Before and after 4 weeks of training, After 6-month

• Epworth Sleepiness Scale (M.W. Johns, 1991)

  Before and after 4 weeks of training, After 6-month

Study Arms (2)

High frequency and intensive prevention

EXPERIMENTAL

High frequency and intensive prevention program 1. Tai Chi 2. CogniFit (cognitive training) 3. SpeechCare (speech training)

Other: High frequency and intensive prevention program

Control group (CogniPlus)

ACTIVE COMPARATOR

Computer-assisted cognitive training program

Other: High frequency and intensive prevention program

Interventions

High frequency and intensive prevention program OTHER

This study is a 4 week non-randomized controlled trial (RCT)

Control group (CogniPlus); High frequency and intensive prevention

Eligibility Criteria

• Age: 18 Years - 86 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Parkinson Schweiz: collaborator

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

Location

Related Publications (1)

• Toloraia K, Gschwandtner U, Fuhr P. High-frequency multimodal training with a focus on Tai Chi in people with Parkinson's disease: a pilot study. Front Aging Neurosci. 2024 Feb 15;16:1335951. doi: 10.3389/fnagi.2024.1335951. eCollection 2024.

  PMID: 38425785 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Peter Fuhr, Prof.Dr.med

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2019
• First Posted: September 25, 2019
• Study Start: July 10, 2020
• Primary Completion: November 1, 2021
• Study Completion: February 1, 2022
• Last Updated: January 6, 2023

Record last verified: 2023-01

Locations

CH (1)