Parkinson DiseaseSENSSNCT06669455
An Integrated and Personalized Lifestyle Approach for People With Parkinson's Disease
A study testing Personalized and combined lifestyle approach in people with Parkinson Disease, run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Personalized and combined lifestyle approach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 1 siteNetherlands
- Study dates
- 12 Nov 2024to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
- Conditions
- Parkinson Disease
- Being tested
- Personalized and combined lifestyle approach
- Keywords
- Lifestyle, Personalized, Stepped Care, Quality of life
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized and combined lifestyle approachBehavioural
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 group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intervention group receiving:
* Intake with lifestyle coach
* Usual Care
* Integrated, combined lifestyle approach (SENSS), including continuous monitoring by lifestyle coach. Receives: Behavioral: Personalized and combined lifestyle approach |
| Control | No intervention | Control group receiving: * Intake with lifestyle coach * Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in quality of life measured with the PDQ-39.
The PDQ-39 consists of 39 questions across 8 dimensions of daily living including relationships, social situations and communication. Item scores range on a 5-point scale from "never" to "always". Both the total score of the PDQ-39 and the scores for each of the 8 dimensions are considered primary outcomes.
Measured: Measured at baseline, and after 6 and 12 months.
Secondary outcomes (16)
Health related quality of life
EuroQol 5D-5L (EQ-5D-5L); The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'The best health you can image' and 'The worst health you can image'.
Measured: Measured at baseline, and after 6 and 12 months.
Parkinson's Disease Symptoms
The Movement Disorders Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) part 1b and part 2. Questions are answered using a 0-4 likert scale ranging from 0 normal to 4 severe.
Measured: Measured at baseline, and after 6 and 12 months.
Fatigue
Fatigue Severity Scale (FSS); This questionnaire consists of nine questions, each rated on a 7-point scale from 1 (strongly disagree) to 7 (strongly agree). A higher score indicates greater fatigue or a more significant impact of fatigue on daily life.
Measured: Measured at baseline, and after 6 and 12 months.
Goal Attainment
The visual analogue scale (VAS) is used to evaluate the lifestyle goals that participants set at the start of the intervention. The VAS is a non-specific measurement tool where patients rate their experience of a given sensation on a scale from 0 to 10.
Measured: Measured at baseline, and after 6 and 12 months.
Diet quality
The Dutch Healthy Diet index 2015 (DHD15-index) consists of fifteen components representing the fifteen food-based Dutch dietary guidelines of 2015. Per component the score ranges between 0 and 10, resulting in a total score between 0 (no adherence) and 150 (complete adherence).
Measured: Measured at baseline, and after 6 and 12 months.
Mood (Anxiety and Depression)
The Hospital Anxiety and Depression Scale (HADS) measures symptoms of anxiety and depression using a 14-item self-report questionnaire, over the past four weeks. It consists of a 7-item anxiety subscale and a 7-item depression subscale. Higher scores on the HADS indicate more symptoms, with a total score range of 0-42.
Measured: Measured at baseline, and after 6 and 12 months.
Physical activity level
The LASA Physical Activity Questionnaire (LAPAQ) consists of 37 items designed to measure physical activities performed over the past week. The questionnaire assesses the frequency and duration of various physical activities. A higher score on the LAPAQ indicates a greater amount of time spent on physical activities.
Measured: Measured at baseline, and after 6 and 12 months.
Insomnia
The Insomnia Severity Index (ISI) consists of seven items that assess various aspects of insomnia. The questionnaire includes the insomnia severity, satisfaction with sleep and impact on daily functioning. Each item is rated on a five-point Likert scale from 0 (not at all) to 4 (extremely), based on the last two weeks. The total score ranges from 0 to 28, with higher scores indicating greater insomnia severity.
Measured: Measured at baseline, and after 6 and 12 months.
Sleepiness
The Epsworth Sleepiness Scale (ESS) is a questionnaire that measures daytime sleepiness by assessing the likelihood of dozing or sleeping in eight different situations on a scale from 0 (would never doze or sleep) to 3 (high chance of dozing or sleeping). The total score ranges from 0 to 24, with higher scores indicating greater sleepiness.
Measured: Measured at baseline, and after 6 and 12 months.
Self-Efficacy
The General Self-Efficacy Scale (GSES) is a 10-item questionnaire (total score range of 10-40) designed to measure a general sense of perceived self-efficacy. A higher score represents higher self-efficacy.
Measured: Measured at baseline, and after 6 and 12 months.
Ilness Acceptance
Acceptance of Disease and Impairments Questionnaire (ADIQ); The questionnaire contains 14 items with a 4-point Likert scale ranging from 1 (disagree) to 4 (entirely agree).
Measured: Measured at baseline, and after 6 and 12 months.
Coping
The ways of coping questionnaire (WCQ); Measures coping on eight dimensions. The questionnaire consists of 67 statements regarding coping in stressful situations. Participants have to score how much they think each statement applies to their situation on a 4-points Likert scale ranging from 0 ("does not apply and/or not used") to 3 ("used a great deal").
Measured: At baseline.
Self-management
The Patient Activation Measure (PAM) is a 13-item survey that assesses an individual's self-reported knowledge, skills, and confidence in managing their health or chronic condition. Each item is rated on a 4-point Likert scale from "totally disagree" to "totally agree" or "non-applicable.
Measured: Measured at baseline, and after 6 and 12 months.
Change in physical activity from baseline to 12 months
Movement data captured with accelerometry data from a wrist worn wearable sensor (Empatica EmbracePlus).
Measured: Measured one week at baseline and one week after 12 months.
Change in sleep time from baseline to 12 months
Captured with accelerometry and photoplethysmogry data from a wrist worn wearable sensor (Empatica EmbracePlus).
Measured: Measured one week at baseline and one week after 12 months.
Change in sleep quality from baseline to 12 months
Captured with accelerometry and photoplethysmogry data from a wrist worn wearable sensor (Empatica EmbracePlus).
Measured: Measured one week at baseline and one week after 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start12 Nov 2024
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 256 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06669455
- Sponsor's protocol ID
- 115891
- Acronym
- SENSS
- Status last verified
- Mar 2026
- First submitted
- 29 Oct 2024
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gaveel TJ, Postma EM, Bloem BR, Darweesh SKL, Munneke M, Overbeek K, Helmich R, Zeevat F, Zijlstra M, Boersma C, Overeem S, Pijpers A, Jakimowicz C, van Gilst MM, Speckens AEM, The R, Manhoudt G, van der Wel A, Duits AA, de Vries NM. The SENSS (Stress, Exercise, Nutrition, Sleep, Self-management) study: study protocol for a randomized controlled trial to evaluate an integrated, personalized and stepped care lifestyle approach for people with Parkinson's disease. Front Neurol. 2026 Mar 3;17:1752073. doi: 10.3389/fneur.2026.1752073. eCollection 2026.
PubMed 41853177
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06669455
- Acronym / sponsor ID
- SENSS / 115891
- Conditions
- Parkinson Disease
- Keywords
- Lifestyle, Personalized, Stepped Care, Quality of life
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 12 Nov 2024 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 1 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Personalized and combined lifestyle approachIntervention group receiving: * Intake with lifestyle coach * Usual Care * Integrated, combined lifestyle approach (SENSS), including continuous monitoring by lifestyle coach. |
| Control | No intervention | –Control group receiving: * Intake with lifestyle coach * Usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized and combined lifestyle approachIn 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'. | Behavioural | Intervention |
Primary outcome
Change in quality of life measured with the PDQ-39.
Time frame: Measured at baseline, and after 6 and 12 months.
The PDQ-39 consists of 39 questions across 8 dimensions of daily living including relationships, social situations and communication. Item scores range on a 5-point scale from "never" to "always". Both the total score of the PDQ-39 and the scores for each of the 8 dimensions are considered primary outcomes.
16 secondary outcomes
Health related quality of life
Time frame: Measured at baseline, and after 6 and 12 months.
Parkinson's Disease Symptoms
Time frame: Measured at baseline, and after 6 and 12 months.
Fatigue
Time frame: Measured at baseline, and after 6 and 12 months.
Goal Attainment
Time frame: Measured at baseline, and after 6 and 12 months.
Diet quality
Time frame: Measured at baseline, and after 6 and 12 months.
Mood (Anxiety and Depression)
Time frame: Measured at baseline, and after 6 and 12 months.
Physical activity level
Time frame: Measured at baseline, and after 6 and 12 months.
Insomnia
Time frame: Measured at baseline, and after 6 and 12 months.
Sleepiness
Time frame: Measured at baseline, and after 6 and 12 months.
Self-Efficacy
Time frame: Measured at baseline, and after 6 and 12 months.
Ilness Acceptance
Time frame: Measured at baseline, and after 6 and 12 months.
Coping
Time frame: At baseline.
Self-management
Time frame: Measured at baseline, and after 6 and 12 months.
Change in physical activity from baseline to 12 months
Time frame: Measured one week at baseline and one week after 12 months.
Change in sleep time from baseline to 12 months
Time frame: Measured one week at baseline and one week after 12 months.
Change in sleep quality from baseline to 12 months
Time frame: Measured one week at baseline and one week after 12 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Derived from this study: PubMed 41853177Gaveel TJ, Postma EM, Bloem BR, Darweesh SKL, Munneke M, Overbeek K, Helmich R, Zeevat F, Zijlstra M, Boersma C, Overeem S, Pijpers A, Jakimowicz C, van Gilst MM, Speckens AEM, The R, Manhoudt G, van der Wel A, Duits AA, de Vries NM. The SENSS (Stress, Exercise, Nutrition, Sleep, Self-management) study: study protocol for a randomized controlled trial to evaluate an integrated, personalized and stepped care lifestyle approach for people with Parkinson's disease. Front Neurol. 2026 Mar 3;17:1752073. doi: 10.3389/fneur.2026.1752073. eCollection 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized and combined lifestyle approach in people with Parkinson Disease, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in quality of life measured with the PDQ-39. (time frame: Measured at baseline, and after 6 and 12 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06669455, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.