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.
Who can participate
Age range
30 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is focused on measuring adherence rather than testing a treatment — can you help me understand what that means in practice, and whether participating would actually change any part of my current Parkinson's care?
2Since the trial is listed as 'not yet recruiting,' do you have any information on when it might open, and is there anything I should do now to stay informed or get on a waitlist?
3The study name includes the word 'Prevention' — can you explain what is being prevented in this context, and whether this trial is aimed at people at my stage of Parkinson's disease or at a different point in the progression?
4Because this trial is listed as Phase NA, which often means it's not testing a drug or device, can you walk me through what I would actually be asked to do if I enrolled, and how time-consuming or disruptive it might be to my daily routine?
5Are there standard-of-care options or other studies I should consider alongside or instead of this one, given that this trial's main goal seems to be studying whether people stick to a protocol rather than directly evaluating a new treatment?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Adherence
Timeframe: From enrollement to the end of the intervention after 6 months.