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Not yet recruitingNCT07297407Updated Dec 22, 2025

Prevention-in-PD-Study

An interventional study of Multidomain lifestyle intervention in Parkinson's Disease (PD), sponsored by University Hospital Schleswig-Holstein. Not yet recruiting. Open to participants aged 30 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-12-22.

Sponsored by University Hospital Schleswig-Holstein · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
99
Allocation
Not applicable
Ages
30 Years to 85 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Parkinson's Disease (PD)

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Keywords

  • lifestyle
  • exercise
  • nutrition
  • cognitive training
  • sleep
03

In context

Motor Activity

2,426 studies on the registry are indexed under Motor Activity; 1,161 are open to participants now.

This study's planned enrollment of 99 is above the median of 60 across 2,118 interventional studies indexed under Motor Activity.

Browse Motor Activity studies →

Lead sponsor

University Hospital Schleswig-Holstein is the lead sponsor of 157 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
99 participants (estimated)

Study arms

  • Experimental
    Multidomain lifestyle intervention

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

    Other: Multidomain lifestyle intervention

Interventions

  • OtherMultidomain lifestyle intervention

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

06

What researchers measure

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).

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07297407
Lead sponsor
University Hospital Schleswig-Holstein
Collaborators
University Hospital, Bonn, University of Cologne, Philipps University Marburg, University of Kiel
Responsible party
Eva Schaeffer (PD Dr. Eva Schäffer, University Hospital Schleswig-Holstein) — Principal investigator
First posted
Dec 22, 2025
Start date
Apr 1, 2026 (estimated)
Primary completion
Sep 2027 (estimated)
Completion
Sep 2027 (estimated)
Last update
Dec 22, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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