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Prevention-in-PD-Study

RecruitingNAAges 30 Years - 85 YearsAllUniversity Hospital Schleswig-Holstein
NCT07297407 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial (feasibility study) is to learn if a multimodal lifestyle program can improve adherence to recommended lifestyle changes in people with REM Sleep Behavior Disroder (RBD) or Parkinson's disease (PD). The main question it aims to answer is if individuals with RBD oder PD can follow a combined lifestyle program over six months Participants will take part in a six-month intervention program that includes: Physical training, Mediterranean diet counseling, Sleep counseling and cognitive training. The program will be supported by psychoeducation, skills training, and personalization to make it practical and motivating.

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📋 Eligibility rules (as published)
Inclusion Criteria: * All participants: ability to perform informed consent; age 30-85 * RBD group: polysomnographic proven diagnosis of isolated REM sleep behavior disorder (iRBD) * PD group: early to moderate disease (Hoehn \& Yahr stage 1-2.5), diagnosis according to the Movement Disorder Society diagnostic criteria for clinical Parkinson's Disease * Agreement to participate in group sessions and online meetings Exclusion Criteria: * dementia (Mini Mental Score, MMSE \< 19 points) (MMSE is specifically chosen here to avoid too frequent repetitions of the MoCA, which is used as an outcome parameter for the interventional trial) * physical inability to perform exercise training or other trainings as judged by a physician * manifest (severe) depression (Beck Depression Inventory, BDI-II \> 29 points) * participation in other interventional trials * other significant diseases of the central nervous system * Planned change in medication within the following 6 months
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What it tests

  • Multidomain lifestyle intervention
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Where

1 site
University Hospital of Schleswig Holstein Campus Kiel
Kiel, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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