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Clinical Trials in the Netherlands / NCT06669455
Active, not recruiting Not applicable

An Integrated and Personalized Lifestyle Approach for People With Parkinson's Disease

NCT06669455 · tracked via the Priya Life Science Netherlands tracker
Sponsor
Radboud University Medical Center
Phase
Not applicable
Started
2024-11-12
Last updated
2026-04-01

Condition(s) studied

Parkinson Disease

Investigational drug(s) / intervention(s)

Personalized and combined lifestyle approach

Personalized and combined lifestyle approach: In the SENSS approach five different and complementary lifestyle domains (self-management, exercise, nutrition, sleep and stress) are combined. The process will be guided by a lifestyle coach. The intervention is personalised for each participant. The personal goals are decided based on 'shared decision making' together with the lifestyle coach after using a Parkinson lifestyle decision aid. The level of guidance needed throughout the intervention is based on a 'stepped care approach'.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * 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. * Planned surgery or a planned major change in healthcare provision.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Radboud University Medical Center Nijmegen Netherlands

More Radboud University Medical Center trials in the Netherlands

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Other trials for the same condition

STEPWISE Parkinson: A Smartphone Based Exercise Solution for Patients With Parkinson's Disease Recruiting
The Personalized Parkinson Project De Novo Cohort Active, not recruiting
Neural Control of Breathing in Parkinson's Disease Recruiting
Slow-SPEED: Slowing Parkinson's Early Through Exercise Dosage Recruiting
Cue2Walk, Cost-effectiveness of Automated Freezing Detection and Provision of External Cues in Comparison to Usual Care in People With Parkinson's Disease Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06669455 on ClinicalTrials.gov ↗ ← All trials in the Netherlands