Prevention-in-PD-Study

NCT07297407 | Not Yet Recruiting

• 1 other identifier: D538-25
• Study Type: interventional
• Target: 99
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Parkinson's Disease (PD)

Keywords

lifestyle; exercise; nutrition; cognitive training; sleep

Outcome Measures

Primary Outcomes (1)

• Adherence

  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).

  From enrollement to the end of the intervention after 6 months.

Study Arms (1)

Multidomain lifestyle intervention

EXPERIMENTAL

Multidomain lifestyle intervention including physical and cognitive training, sleep and nutrition counceling

Other: Multidomain lifestyle intervention

Interventions

Multidomain lifestyle intervention OTHER

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

Multidomain lifestyle intervention

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Schleswig-Holstein: lead
• University Hospital, Bonn: collaborator
• University of Cologne: collaborator
• Philipps University Marburg: collaborator
• University of Kiel: collaborator

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. Eva Schäffer

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: December 22, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: December 22, 2025

Record last verified: 2025-12