NCT07297407

Prevention-in-PD-Study

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 99 (estimated)
• Sponsor: University Hospital Schleswig-Holstein · Academic / Other
• Sex: All
• Age: 30 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Parkinson's Disease (PD)

Interventions

Type	Name	Description
OTHER	Multidomain lifestyle intervention	Lifestyle intervention including physical and cognitive training, nutritional and sleep counseling

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-09-01
• Completion: 2027-09-01
• First posted: 2025-12-22
• Last updated: 2025-12-22