Prevention in PD: a six-month lifestyle program for PD and RBD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This feasibility trial investigates if a multimodal lifestyle program can support adherence to lifestyle changes in people with Parkinson’s disease (PD) and REM sleep behavior disorder (RBD) over six months. Participants engage in structured physical training, diet counseling, sleep optimization, and cognitive training, with psychoeducation and personalization to boost motivation. The study also looks for early signals of impact on symptoms, quality of life, and overall health. It is conducted in Germany with multiple collaborating centers and is powered to assess feasibility and potential benefits rather than definitive clinical outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

• University Hospital of Schleswig Holstein Campus Kiel
  Kiel, Germany Recruiting

Study contacts

• Study coordinator: Eva Schaeffer
• Email: info.prevention.kiel@uksh.de
• Phone: 0049 043150023989

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.