Prevention-in-PD-Study

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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Key information

Conditions

Parkinson's Disease (PD) Behavior Motor Activity

Age range

30 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Parkinson's disease (PD) is becoming more common worldwide, but there are still no treatments that can slow down or stop the disease. Lifestyle changes such as more physical activity, a healthy diet, good sleep, and mental training may help slow down the progression of the disease. However, it is often difficult for people to follow several lifestyle changes at the same time, and no study has yet tested how well this works in Parkinson's.

The PREVENTION-IN-PD study will test a new lifestyle program for people with PD and people with REM Sleep Behavior Disorder (RBD, at risk for developing Parkinson's Disease) in Germany. Over six months, participants will receive support in four areas: exercise, Mediterranean diet, sleep habits, and cognitive training. The program is designed to be practical, personalized, and motivating.

The main goal is to see whether people with PD and RBD can stick to these lifestyle changes over time. The study will also look at potential early effects on symptoms, quality of life, and overall health. If successful, this project will be the first step toward making lifestyle programs an important part of Parkinson's care in Germany and beyond.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multidomain lifestyle intervention

Other

Lifestyle intervention including physical and cognitive training, nutritional and sleep counseling

Primary outcomes

Adherence

Time frame: From enrollement to the end of the intervention after 6 months.

Adherence to the multimodal lifestyle intervention program is objectively recorded as the primary outcome parameter (participation in the planned training sessions in %). In addition, subjective adherence is recorded (assessment of the implementation of lifestyle measures in everyday life using a Likert scale).

Sponsors and collaborators

Lead sponsor

University Hospital Schleswig-Holstein

Other

Collaborators

Philipps University Marburg
University Hospital, Bonn
University of Cologne
University of Kiel

Registry information

Official study title

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

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Dec 22, 2025
Registry last updated: Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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