G20.00
Conditions
Interventions
Group 1: All study participants will receive a six-month multimodal lifestyle intervention program consisting of physical training, Mediterranean diet guidance, sleep counseling, and cognitive trainin
Sponsors
Klinik für Neurologie
Eligibility
Sex/Gender
All
Age
30 Years to 85 Years
Inclusion criteria
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 29 points) • participation in other interventional trials • other significant diseases of the central nervous system • Planned change in medication within the following 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is adherence to a healthy lifestyle. To this end, a short weekly survey is conducted to assess participation in the training program and implementation in everyday life. | — |
Secondary
| Measure | Time frame |
|---|---|
| •Domain-specific adherence: to evaluate adherence to each individual domain (adherence percentage value of each domain). The comparison of the individual adherence to the specific domains serves to evaluate the specifically designed domain programs, e.g. with regard to feasibility in everyday life. In addition, it may be possible to draw initial conclusions as to which individual patient profiles can predict adherence to certain programs. •Disease-phase specific adherence: to compare adherence to the program between individuals with prodromal and clinical PD. This is of particular interest in order to find out whether a high level of adherence can already be achieved in individuals in the prodromal phase despite a low (motor) symptom burden. •Domain-associated outcome parameters: To assess changes over time from baseline to six months, quantitative measures for each domain will be evaluated, which may serve as a basis for future randomized studies. •Physical training associated outcomes: coordination, grip force, aerobic capacity, physical activity readiness (questionnaire and physical tests) •Nutritional counseling associated outcomes: food composition and food literacy (questionnaires) •Sleep counseling associated outcomes: severity of PD-associated sleep disorders, physical sleep parameters (sleep phases, wake periods/interruptions, sleep duration, movements, breathing frequency, heart rate) (questionnaires and sleep measurement using at home sleep monitoring). •Cognitive training associated outcomes: cognitive function (cognitive assessment) and subjective cognitive decline (questionnaire) | — |
Countries
Germany
Contacts
Public ContactEva Schäffer
Klinik für Neurologie
Outcome results
None listed