Movement DisordersSTEPWISENCT04848077
STEPWISE Parkinson: A Smartphone Based Exercise Solution for Patients With Parkinson's Disease
A study testing Step count increase with the use of a motivational smartphone application in people with Movement Disorders and Parkinson Disease, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
The aim of this study is to investigate whether a smartphone app can increase physical activity in patients with Parkinson's Disease in daily life for a long period of time (12 months). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Movement Disorders, Parkinson Disease
- What is being tested?
- Step count increase with the use of a motivational smartphone application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 452 participants
- Where
- 1 siteNetherlands
- Study dates
- 18 May 2021to Sep 2026
- 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
- idiopathic PD
- Hoehn and Yahr 1-3
- able to understand the Dutch language
- able to walk independently
- equal to or less than 120 minutes of sports/outdoor activities per day (question 5-28 LASA Physical Activity Questionnaire (LAPAQ))
- less than 7,000 steps/day during 1-month baseline (week -4 until 0)
Who cannot join
- weekly falls in the previous 3 months
- medical conditions that hamper mobility other than PD
- living in a nursing home
- cognitive impairments that hamper use of the motivational app (subjective evaluation by the assessor)
- not in the possession of a suitable smartphone (Iphone 5S or newer with iOS 10 or higher or Android 4.1 or newer)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Radboud university medical center
Nijmegen, Gelderland, 6500 HB
Sabine Schootemeijer, MSc., 00316 50155754, sabine.schootemeijer@radboudumc.nl
About this study
Official title: STEPWISE Parkinson: A Smartphone Based, Titrated Exercise Solution for Patients With Parkinson's Disease in Daily Life
The aim of this study is to investigate whether a smartphone app can increase physical activity in patients with Parkinson's Disease in daily life for a long period of time (12 months).
Read the detailed description
Rationale: Exercise affords health benefits for people with Parkinson's disease (PD), but implementing exercise in daily life remains challenging. Moreover, many training programs are not very scalable. The investigators take an important step forward by developing and studying an innovative and fully decentralized smartphone-based program to increase long-term physical activity in people with PD in daily life.
Objective: The aim of this study is to investigate whether a smartphone app can increase physical activity in PD patients for a long period of time (12 months). The secondary aim is to test the potential group effect on physical fitness, motor- and non-motor symptoms. Thirdly, we aim to investigate whether there is a dose-response relationship between amount of physical activity and physical fitness, motor- and non-motor functioning.
Study design: Double-blind randomized controlled trial.
Study population: A total of 452 Dutch patients with PD who have no other medical conditions that markedly hamper mobility other than PD, no cognitive impairments that make it difficult to use a game on the smartphone and possess a suitable smartphone, will be recruited.
Intervention: Participants will be randomized to a group that will be motivated to increase their physical activity level to a small, medium, large or very large degree with respect to their own baseline level.
- Conditions
- Movement Disorders, Parkinson Disease
- Being tested
- Step count increase with the use of a motivational smartphone application
- Keywords
- Physical activity, Walking, Exercise, Parkinson Disease, Locomotion, Motivational application
- Medical subject headings
- Movement Disorders, Parkinson Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Step count increase with the use of a motivational smartphone applicationBehavioural
All participants will be given access to an application installed on the participants' own smartphone: the STEPWISE app. The STEPWISE app will encourage participants to increase their long-term physical activity (1 year). Different treatment arms will receive different physical activity goals. Participants will get feedback and support via the smartphone app, that stimulates them to reach their individual physical activity goal (i.e. target percentage increase in stepcount).
| Study group | Role | What they receive |
|---|---|---|
| Very high dose | Experimental | Very large proportional increase in stepcount relative to baseline stepcount. Receives: Behavioral: Step count increase with the use of a motivational smartphone application |
| High dose | Experimental | Large proportional increase in stepcount relative to baseline stepcount. Receives: Behavioral: Step count increase with the use of a motivational smartphone application |
| Intermediate dose | Experimental | Medium proportional increase in stepcount relative to baseline stepcount. Receives: Behavioral: Step count increase with the use of a motivational smartphone application |
| Active controls | Active comparator | Small proportional increase in stepcount relative to baseline stepcount. Receives: Behavioral: Step count increase with the use of a motivational smartphone application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in step count per day
Mean change in step count per day as measured continuously with the participant's smartphone from baseline (week -4 to 0) to follow-up (week 49-52). Higher scores indicate more physical activity (steps).
Measured: Week -4 until 0 and week 49 until 52
Secondary outcomes (22)
Change in physical fitness (6MWT)
Change from baseline in meters walked during the six minute walk test (6MWT) at week 53 (follow-up). Higher scores indicate better function.
Measured: Week 0 (baseline) and week 53 (follow-up)
Change in motor- and non-motor aspects of daily living
Change from baseline in the Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) parts Ib and II at 53 weeks (follow-up). Range 0-80. Higher scores indicate worse function.
Measured: Week 0 (baseline) and week 53 (follow-up)
Change in physical fitness (VO2max)
Change from baseline in VO2max in ml/kg/min assessed by a maximal aerobic exercise test on a cycle ergometer at follow-up (week 53). Higher scores indicate better function. Performed in a subgroup of 100 participants.
Measured: Week 0 (baseline) and week 53 (follow-up)
Change in Parkinson's Disease symptoms (MDS-UPDRS)
Change from baseline in the Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) at 53 weeks (follow-up). Range 0-199. Higher scores indicate worse function.
Total scores for Parts I, II, III, and IV will also be calculated.
Measured: Week 0 (baseline) and week 53 (follow-up)
Change in ambulatory capacity (MDS-UPDRS)
Change from baseline in the sum of 5 MDS-UPDRS questions: walking and balance [question 2.12], freezing [q. 2.13], gait [q. 3.10], freezing of gait [q. 3.11], and postural stability [q. 3.12]). Higher scores imply worse symptoms.
Measured: Week 0 (baseline) and week 53 (follow-up)
Change in mobility (TUG)
Change from baseline in the time (seconds) needed to complete the Timed Up and Go Test (TUG) at 53 weeks (follow-up). Higher scores indicate worse function.
Measured: Week 0 (baseline) and week 53 (follow-up)
Change in balance (Mini-BestTest)
Change from baseline on the Mini-BestTest at 53 weeks (follow-up).Range 0-28. Higher scores indicate better function.
Measured: Week 0 (baseline) and week 53 (follow-up)
Change in gait speed (10MWT)
Change from baseline in gait speed (m/s) as assessed by the 10 meter walk test (10MWT). Higher scores indicate better function.
Measured: Week 0 (baseline) and week 53 (follow-up)
Change in fear of falling (FES-I)
Change from baseline on the Dutch version of the Falls Efficacy Scale International at 53 weeks (follow-up). Range 16-64. Higher scores indicate higher fear of falling.
Measured: Week 0 (baseline) and week 53 (follow-up)
Number of falls and near-falls (monthly fall diary)
Number of falls and near-falls reported monthly by the participants in a fall diary drafted according to the European Physiotherapy guideline for Parkinson's Disease.
Measured: Every four weeks after start of the intervention (at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 weeks).
Change in handgrip strength
Change from baseline in hand grip strength (kg) as assessed with a dynamometer (best out of three attempts).
Measured: Week 0 (baseline) and week 53 (follow-up)
Change in self-reported physical activity level (LAPAQ)
Change from baseline on the Longitudinal Aging Study Amsterdam (LASA) physical Activity Questionnaire (LAPAQ). Higher scores indicate a higher physical activity level.
Measured: Week -4 (screening), week 0 (baseline) and week 53 (follow-up)
Change in cognition (MOCA)
Change from baseline on the Montreal Cognitive Assessement (MOCA) score at 53 weeks (follow-up). Range 0-30. Higher scores indicate better cognition.
Measured: Week 0 (baseline) and week 53 (follow-up)
Change in depression and anxiety (HADS)
Change from baseline on the Hospital Anxiety and Depression Scale (HADS) at 53 weeks (follow-up). Range 0-42. Higher scores indicate worse function.
Measured: Week 0 (baseline) and week 53 (follow-up)
Change in apathy (AES-12PD)
Change from baseline on the Apathy Evaluation Scale (AES-12PD) at 53 weeks (follow-up). Range 12-48. Higher scores indicate better function.
Measured: Week 0 (baseline) and week 53 (follow-up)
Change in fatigue (FSS)
Change from baseline on the Fatigue Severity Scale (FSS) at 53 weeks (follow-up). Range 1-7. Higher scores indicate worse function.
Measured: Week 0 (baseline) and week 53 (follow-up)
Change in severity of sleep problems and daytime sleepiness (SCOPA-SLEEP)
Change from baseline on the Scales for Outcomes in Parkinson's Disease - Sleep (SCOPA-Sleep) questionnaire at 53 weeks (follow-up).
Measured: Week 0 (baseline) and week 53 (follow-up)
Change in autonomic dysfunction (SCOPA-AUT)
Change from baseline on the Scales for Outcomes in Parkinson's Disease - autonomic questionnaire (SCOPA-AUT) at 53 weeks (follow-up).
Measured: Week 0 (baseline) and week 53 (follow-up)
Change in Health related quality of life (PDQ-39)
Change from baseline on the Health related quality of life (PDQ-39) questionnaire at 53 weeks (follow-up). Range 0-100. Higher scores indicate better function.
Measured: Week 0 (baseline) and week 53 (follow-up)
Perceived effect of intervention (GPE)
Perceived effect of intervention as assessed by the Global Perceived effect (GPE) questionnaire (7-point scale) at 53 weeks (follow-up). Range 1-7. Higher scores indicate higher perceived effect.
Measured: At week 53 (follow-up)
System Usability (SUS)
Usability of the STEPWISE application as assessed by the Dutch version of the System Usability Scale (SUS) at 53 weeks (follow-up). Range 0-100. Higher scores indicate better usability.
Measured: At week 53 (follow-up)
Perceived physical ability (LIVAS)
Change from baseline on the percieved physical ability scale (Lichamelijke Vaardigheden Schaal; LIVAS) at 53 weeks (follow-up). Range 10-50. Higher scores indicate higher perceived phisical ability.
Measured: Week 0 (baseline) and week 53 (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start18 May 2021
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (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 Movement DisordersStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 452 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, Massachusetts General Hospital, Hogeschool van Arnhem en Nijmegen (HAN), Canisius-Wilhelmina Hospital, IJsfontein Health BV
- Responsible party
- Sponsor
- Investigators
- Bastiaan Bloem, Prof. Dr., Principal investigator, Radboudumc Department of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04848077
- Sponsor's protocol ID
- NL75501.091.20
- Acronym
- STEPWISE
- Status last verified
- Nov 2024
- First submitted
- 13 Apr 2021
- Last updated
- 20 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will make relevant and anonymised data available in a validated database.
Publications
Schootemeijer S, de Vries NM, Macklin EA, Roes KCB, Joosten H, Omberg L, Ascherio A, Schwarzschild MA, Bloem BR. The STEPWISE study: study protocol for a smartphone-based exercise solution for people with Parkinson's Disease (randomized controlled trial). BMC Neurol. 2023 Sep 12;23(1):323. doi: 10.1186/s12883-023-03355-8.
PubMed 37700241
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STEPWISE Parkinson: A Smartphone Based, Titrated Exercise Solution for Patients With Parkinson's Disease in Daily Life
- ClinicalTrials.gov ID
- NCT04848077
- Acronym / sponsor ID
- STEPWISE / NL75501.091.20
- Conditions
- Movement Disorders, Parkinson Disease
- Keywords
- Physical activity, Walking, Exercise, Parkinson Disease, Locomotion, Motivational application
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 452 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, Massachusetts General Hospital, Hogeschool van Arnhem en Nijmegen (HAN), Canisius-Wilhelmina Hospital, IJsfontein Health BV
- Study start
- 18 May 2021 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 19 Apr 2021 (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 aim of this study is to investigate whether a smartphone app can increase physical activity in patients with Parkinson's Disease in daily life for a long period of time (12 months).
Detailed description
Rationale: Exercise affords health benefits for people with Parkinson's disease (PD), but implementing exercise in daily life remains challenging. Moreover, many training programs are not very scalable. The investigators take an important step forward by developing and studying an innovative and fully decentralized smartphone-based program to increase long-term physical activity in people with PD in daily life.
Objective: The aim of this study is to investigate whether a smartphone app can increase physical activity in PD patients for a long period of time (12 months). The secondary aim is to test the potential group effect on physical fitness, motor- and non-motor symptoms. Thirdly, we aim to investigate whether there is a dose-response relationship between amount of physical activity and physical fitness, motor- and non-motor functioning.
Study design: Double-blind randomized controlled trial.
Study population: A total of 452 Dutch patients with PD who have no other medical conditions that markedly hamper mobility other than PD, no cognitive impairments that make it difficult to use a game on the smartphone and possess a suitable smartphone, will be recruited.
Intervention: Participants will be randomized to a group that will be motivated to increase their physical activity level to a small, medium, large or very large degree with respect to their own baseline level.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Very high dose | Experimental | Behavioral: Step count increase with the use of a motivational smartphone applicationVery large proportional increase in stepcount relative to baseline stepcount. |
| High dose | Experimental | Behavioral: Step count increase with the use of a motivational smartphone applicationLarge proportional increase in stepcount relative to baseline stepcount. |
| Intermediate dose | Experimental | Behavioral: Step count increase with the use of a motivational smartphone applicationMedium proportional increase in stepcount relative to baseline stepcount. |
| Active controls | Active comparator | Behavioral: Step count increase with the use of a motivational smartphone applicationSmall proportional increase in stepcount relative to baseline stepcount. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- idiopathic PD
- Hoehn and Yahr 1-3
- able to understand the Dutch language
- able to walk independently
- equal to or less than 120 minutes of sports/outdoor activities per day (question 5-28 LASA Physical Activity Questionnaire (LAPAQ))
Key exclusion criteria (5 listed)
- weekly falls in the previous 3 months
- medical conditions that hamper mobility other than PD
- living in a nursing home
- cognitive impairments that hamper use of the motivational app (subjective evaluation by the assessor)
- not in the possession of a suitable smartphone (Iphone 5S or newer with iOS 10 or higher or Android 4.1 or newer)
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 |
|---|---|---|
| Step count increase with the use of a motivational smartphone applicationAll participants will be given access to an application installed on the participants' own smartphone: the STEPWISE app. The STEPWISE app will encourage participants to increase their long-term physical activity (1 year). Different treatment arms will receive different physical activity goals. Participants will get feedback and support via the smartphone app, that stimulates them to reach their individual physical activity goal (i.e. target percentage increase in stepcount). | Behavioural | Active controls, High dose, Intermediate dose, Very high dose |
Primary outcome
Mean change in step count per day
Time frame: Week -4 until 0 and week 49 until 52
Mean change in step count per day as measured continuously with the participant's smartphone from baseline (week -4 to 0) to follow-up (week 49-52). Higher scores indicate more physical activity (steps).
22 secondary outcomes
Change in physical fitness (6MWT)
Time frame: Week 0 (baseline) and week 53 (follow-up)
Change in motor- and non-motor aspects of daily living
Time frame: Week 0 (baseline) and week 53 (follow-up)
Change in physical fitness (VO2max)
Time frame: Week 0 (baseline) and week 53 (follow-up)
Change in Parkinson's Disease symptoms (MDS-UPDRS)
Time frame: Week 0 (baseline) and week 53 (follow-up)
Change in ambulatory capacity (MDS-UPDRS)
Time frame: Week 0 (baseline) and week 53 (follow-up)
Change in mobility (TUG)
Time frame: Week 0 (baseline) and week 53 (follow-up)
Change in balance (Mini-BestTest)
Time frame: Week 0 (baseline) and week 53 (follow-up)
Change in gait speed (10MWT)
Time frame: Week 0 (baseline) and week 53 (follow-up)
Change in fear of falling (FES-I)
Time frame: Week 0 (baseline) and week 53 (follow-up)
Number of falls and near-falls (monthly fall diary)
Time frame: Every four weeks after start of the intervention (at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 weeks).
Change in handgrip strength
Time frame: Week 0 (baseline) and week 53 (follow-up)
Change in self-reported physical activity level (LAPAQ)
Time frame: Week -4 (screening), week 0 (baseline) and week 53 (follow-up)
Change in cognition (MOCA)
Time frame: Week 0 (baseline) and week 53 (follow-up)
Change in depression and anxiety (HADS)
Time frame: Week 0 (baseline) and week 53 (follow-up)
Change in apathy (AES-12PD)
Time frame: Week 0 (baseline) and week 53 (follow-up)
Change in fatigue (FSS)
Time frame: Week 0 (baseline) and week 53 (follow-up)
Change in severity of sleep problems and daytime sleepiness (SCOPA-SLEEP)
Time frame: Week 0 (baseline) and week 53 (follow-up)
Change in autonomic dysfunction (SCOPA-AUT)
Time frame: Week 0 (baseline) and week 53 (follow-up)
Change in Health related quality of life (PDQ-39)
Time frame: Week 0 (baseline) and week 53 (follow-up)
Perceived effect of intervention (GPE)
Time frame: At week 53 (follow-up)
System Usability (SUS)
Time frame: At week 53 (follow-up)
Perceived physical ability (LIVAS)
Time frame: Week 0 (baseline) and week 53 (follow-up)
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 20 Apr 2025.
- Derived from this study: PubMed 37700241Schootemeijer S, de Vries NM, Macklin EA, Roes KCB, Joosten H, Omberg L, Ascherio A, Schwarzschild MA, Bloem BR. The STEPWISE study: study protocol for a smartphone-based exercise solution for people with Parkinson's Disease (randomized controlled trial). BMC Neurol. 2023 Sep 12;23(1):323. doi: 10.1186/s12883-023-03355-8.
- Individual participant dataSharing planned: Yes. We will make relevant and anonymised data available in a validated database.
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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.
Bastiaan Bloem, Prof. Dr. principal investigator
Radboudumc Department of Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Step count increase with the use of a motivational smartphone application in people with Movement Disorders and 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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 20 Apr 2025. 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?
Contact Sabine Schootemeijer, MSc (00316 50155754, sabine.schootemeijer@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in step count per day (time frame: Week -4 until 0 and week 49 until 52). 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 NCT04848077, 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 20 Apr 2025.