Personalized lifestyle program 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
This study tests whether a personalized lifestyle program can improve the quality of life for people with Parkinson's disease by focusing on exercise, nutrition, sleep, and stress management.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 256 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Radboud University Medical Center Academic / other |
| Locations | 1 site (Nijmegen) |
| Trial ID | NCT06669455 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of a combined lifestyle program on the quality of life for individuals with Parkinson's Disease. Participants will be randomly assigned to either a self-managed group or a guided group with a lifestyle coach over a 12-month period. The program emphasizes self-management strategies, including exercise, nutrition, sleep, and stress management, and participants will complete questionnaires and use wearable sensors to track their progress. The primary outcome is the quality of life measured by the PDQ-39 questionnaire, along with personal goal achievements and symptom changes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 or older with idiopathic Parkinson's Disease at any stage of severity who are proficient in Dutch.
Not a fit: Patients with cognitive impairments that prevent them from completing questionnaires or those without access to electronic devices may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve the quality of life for patients with Parkinson's Disease.
How similar studies have performed: Other studies have shown positive outcomes with lifestyle interventions for chronic conditions, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Nijmegen
- Radboud University Medical Center — Nijmegen, Netherlands (Recruiting)
Study contacts
- Study coordinator: Ties Gaveel
- Email: ties.gaveel@radboudumc.nl
- Phone: +31615565773
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.