Prevention-in-PD-Study
ConditionParkinson's Disease (PD)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-85
SponsorUniversity Hospital Schleswig-Holstein
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Multidomain lifestyle intervention
Other interventionLifestyle intervention including physical and cognitive training, nutritional and sleep counseling
Treatment groups
99 Participants
are divided into 1 treatment groupGroup A: Multidomain lifestyle interventionExperimental treatment 1 intervention
Trial outcomes
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.Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital Schleswig-Holstein
Lead sponsor
University Hospital, Bonn
Collaborator
University of Cologne
Collaborator
Philipps University Marburg
Collaborator
University of Kiel
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: