RECRUITING Not applicable ClinicalTrials.gov

Prevention-in-PD-Study

Sponsor: University Hospital Schleswig-Holstein • ClinicalTrials.gov ID: NCT07297407

Registry updated: 2026-10-15

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Description

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.

Interventions

Multidomain lifestyle intervention (Other)
Lifestyle intervention including physical and cognitive training, nutritional and sleep counseling

Eligibility criteria

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

Conditions

Parkinson's Disease (PD)

Locations

University Hospital of Schleswig Holstein Campus Kiel — Kiel, Germany

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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