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NCT07297407Recruiting

Prevention-in-PD-Study

PREVENTION-IN-PD - Development of a Multidomain Lifestyle Intervention Study for Prodromal and Clinical Parkinson's Disease

Source: ClinicalTrials.gov · Last updated 15 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
99 (estimated)
First submitted
16 Sept 2025
Start date
1 Apr 2026
Primary completion date
Sept 2027
Lead sponsor
University Hospital Schleswig-Holstein
NCT number
NCT07297407

What you commit to

  • Study type: Interventional
  • Planned participants: 99
  • From 1 Apr 2026 to the primary completion date, Sept 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Planned change in medication within the following 6 months

Other illness

  • 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)
  • other significant diseases of the central nervous system

Other

  • 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

Who the study is looking for

  • 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

Age in the registry: 30 years to 85 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University Hospital of Schleswig Holstein Campus Kiel
Coordinator of this site? Confirm its status
KielGermanyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.