NCT06669455Active, not recruiting
An Integrated and Personalized Lifestyle Approach for People With Parkinson's Disease
SENSS (Stress, Exercise, Nutrition, Sleep, Self-management): An Integrated, Personalized and Stepped Care Lifestyle Approach for People With Parkinson's Disease: A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 1 Apr 2026
Brief summary (registry, in English)
The goal of this study is to investigate the effects of a combined lifestyle program on the quality of life in people with Parkinson's Disease. Participants will be randomly assigned to one of two groups, both receiving standard care, a Parkinson Lifestyle Decision aid and an intake meeting with a lifestyle coach. One group will work on their goals independently, while the other group will get guidance from the lifestyle coach throughout the 12-month program. The program focuses on self-management, exercise, nutrition, sleep and stress. Participants will complete questionnaires after 0, 6 and 12 months, and use a wearable sensor for two weeks. The main outcome is quality of life over 12 months, measured with the PDQ-39 questionnaire. The study also examines personal goal achievements, symptom changes, and the economic effects of the program.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 256 (estimated)
- First submitted
- 29 Oct 2024
- Start date
- 12 Nov 2024
- Primary completion date
- Mar 2027
- Lead sponsor
- Radboud University Medical Center
- Diseases
- Parkinson disease
- NCT number
- NCT06669455
What you commit to
- Study type: Interventional
- Planned participants: 256
- From 12 Nov 2024 to the primary completion date, Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Planned surgery or a planned major change in healthcare provision.
Other
- Cognitive impairments that do not allow to fill out the questionnaires, as judged by the researcher during the screening call.
- Not in possession of or no access to an electronic device that allows for (video) calls with a lifestyle coach, and to complete questionnaires.
Who the study is looking for
- Parkinson's disease (idiopathic) in all stages of severity
- Proficient in Dutch, for both the data collection (questionnaires) and the intervention (all of the apps/modules are in Dutch)
- Aged 18 or older
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Radboud University Medical Center Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.