Slow-SPEED-NL: Slowing Parkinson's Early Through Exercise Dosage-Netherlands

Browse trials for

• Parkinson Disease 4,573
• Neurodegenerative Diseases 436
• Parkinsonian Disorders 218
• REM Sleep Behavior Disorder 101
• Basal Ganglia Diseases 40
• Central Nervous System Diseases 386

Keywords

• Physical Activity
• Prevention
• Remote
• Mobile Health (mHealth)
• Feasibility
• Exercise
• Digital biomarker
• Blood
• Imaging
• MRI
• Motivational application
• Walking
• Parkinson Disease
• Prodromal

Parkinson Disease

4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.

This study's planned enrollment of 110 is above the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.

Lead sponsor

Radboud University Medical Center is the lead sponsor of 986 studies on the registry; 136 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Eligibility criteria

Study arms

• Experimental
  Intervention

  Large proportional increase in step count and minutes exerting moderate to vigorous physical activity (MVPA) relative to baseline level.

  Behavioral: Increase of physical activity volume and intensity with the use of a motivational smartphone application

• Active comparator
  Active control

  Small proportional increase in step count and minute exerting moderate to vigorous physical activity (MVPA) relative to baseline level.

  Behavioral: Increase of physical activity volume and intensity with the use of a motivational smartphone application

Interventions

• BehavioralIncrease of physical activity volume and intensity with the use of a motivational smartphone application

  A motivational smartphone application will be available for all participants using their own smartphone: the Slow-SPEED app. The Slow-SPEED app will motivate participants to increase the volume and intensity of their physical activity in daily life over a long period of time (2 years) based on their own baseline levels. Different treatment arms will receive different physical activity goals. The app offers participants feedback and support, that will stimulate them to reach their individual physical activity goal (i.e. incremental relative increase of step count and minutes exerting ≥ 64% of maximum heart rate reflecting MVPA relative to baseline level.).

Primary outcomes

1. Mean change in step count per day

   Mean change in step count per day as measured continuously with a smartwatch. Mean steps per day will be calculated from 4-week periods. Higher positive change in step count indicate more volume of physical activity.

   Time frame: All 4 week periods between and including week -4 until 0 (baseline period) and week 100 until 104 (follow-up period)

Secondary outcomes

1. Change in moderate to vigorous physical activity (MVPA) per day

   Change in number of minutes exerting (minimally) ≥ 64% of maximum heart rate, reflecting moderate intense physical activity, measured continuously using a smartwatch. Mean minutes per day will be calculated from 4-week periods. Higher positive change in minutes of MVPA indicate more aerobic physical activity.

   Time frame: All 4 week periods between and including week -4 until 0 (baseline period) and week 100 until 104 (follow-up period)

2. Change in resting heart rate (physical fitness)

   Change in resting heart rate per day as measured continuously with a smartwatch. Mean resting heart rate per day will be calculated from 4-week periods. Higher negative change (i.e. lower resting heart rate) indicate better function.

   Time frame: All 4 week periods between and including week -4 until 0 (baseline period) and week 100 until 104 (follow-up period)

3. Change in heart rate variability (physical fitness)

   Change in heart rate variability in Root Mean Square of Successive Differences (RMSSD) measured every 5 minutes with a smartwatch. Mean RMSSD per day will be calculated from 4-week periods. Higher positive change in RMSSD indicate better function.

   Time frame: All 4 week periods between and including week -4 until 0 (baseline period) and week 100 until 104 (follow-up period)

4. Change in blood pressure (physical fitness)

   Change from baseline (week 0) blood pressure in mmHg assessed by a sphygmomanometer at follow-up (week 104). Lower scores indicate better function.

   Time frame: Week 0 (baseline) and week 104 (follow-up)

5. Change in VO2max (physical fitness)

   Change in VO2max in ml/kg/min measured per day with a smartwatch. Mean VO2max per day will be calculated from 4-week periods. Higher positive change in VO2max indicate better function.

   Time frame: All 4 week periods between and including week -4 until 0 (baseline period) and week 100 until 104 (follow-up period)

6. Change in heart rate variability (autonomic function)

   Mean change in heart rate variability in Root Mean Square of Successive Differences (RMSSD) measured every 5 minutes with a smartwatch. Mean RMSSD per day will be calculated from 4-week periods. Higher positive change in RMSSD indicate better function.

   Time frame: All 4 week periods between and including week -4 until 0 (baseline period) and week 100 until 104 (follow-up period)

7. Change in orthostatic blood pressure (autonomic function)

   Change in baseline (week 0) difference between supine and standing blood pressure measured with a sphygmomanometer to follow-up (week 104). Higher change indicate more autonomic dysfunction.

   Time frame: Week 0 (baseline) and week 104 (follow-up)

8. Change in anxiety and depression (HADS)

   Change from baseline (week 0) on the Hospital Anxiety and Depression Scale (HADS) at week 52 (1 year) and week 104 (follow-up). Range 0-42. Higher scores indicate worse function.

   Time frame: Week 0 (baseline), week 52 (1 year), week 104 (follow-up)

9. Change in cognition (MoCA)

   Change from baseline (week 0) on the Montreal Cognitive Assessment (MoCA) at week 104 (follow-up). Range 0-30. Higher scores indicate better function.

   Time frame: Week 0 (baseline), week 104 (follow-up)

10. Mean change in light sleep (sleep stage)

    Mean change in light sleep stage measured continuously with a smartwatch. Mean duration of light sleep per day will be calculated from 4-week periods. Higher positive change indicate more light sleep.

    Time frame: All 4 week periods between and including week -4 until 0 (baseline period) and week 100 until 104 (follow-up period)

11. Mean change in deep sleep (sleep stage)

    Mean change in deep sleep stage measured continuously with a smartwatch. Mean duration of deep sleep per day will be calculated from 4-week periods. Higher positive change indicate more deep sleep.

    Time frame: All 4 week periods between and including week -4 until 0 (baseline period) and week 100 until 104 (follow-up period)

12. Mean change in REM sleep (sleep stage)

    Mean change in rapid eye movement (REM) sleep stage measured continuously with a smartwatch. Mean duration of REM sleep per day will be calculated from 4-week periods. Higher positive change indicate more REM sleep.

    Time frame: All 4 week periods between and including week -4 until 0 (baseline period) and week 100 until 104 (follow-up period)

13. Change in self-reported sleep quality (PSQI)

    Change from baseline (week 0) on the Pittsburgh Sleep Quality Index (PSQI) at week 52 (1 year) and week 104 (follow-up). Range 0-21. Higher scores indicate worse sleep quality.

    Time frame: Week 0 (baseline), week 52 (1 year), week 104 (follow-up)

14. Change in olfaction (UPSIT)

    Change from baseline (week 0) on the University of Pennsylvania Smell Identification Test (UPSIT) at week 104 (follow-up). Range 0-40. Higher scores indicate better function.

    Time frame: Week 0 (baseline), week 104 (follow-up)

15. Change in motor symptoms (Roche PD Research mobile application)

    Change in motor symptoms measured digitally with the smartphone using the Roche PD Research mobile application. Higher scores indicate worse function.

    Time frame: Week 0 (baseline), week 6, week 12, week 18, week 24, week 30, week 36, week 42, week 48, week 54, week 60, week 66, week 72, week 78, week 84, week 90, week 96, week 102

16. Change in metabolism (blood based biomarkers)

    Change from baseline (week 0) on glucose and HbA1c at follow-up (week 104). Optional at week 26, week 52 and week 78. Lower scores indicate better metabolism.

    Time frame: Week 0 (baseline), week 26 (optional), week 52 (optional), week 78 (optional) and week 104 (follow-up)

17. Change in inflammation (blood based biomarkers)

    Change from baseline (week 0) on Tumor Necrosis Factor-α, Interleukin-6 (IL-6), IL-18, IGF-1, clusterin, Il-10, PGC-α (irisin) at follow-up (week 104). Optional at week 26, week 52 and week 78. Lower inflammatory markers indicate less inflammation. Higher anti-inflammatory markers indicate less inflammation.

    Time frame: Week 0 (baseline), week 26 (optional), week 52 (optional), week 78 (optional) and week 104 (follow-up)

18. Change in growth factors (blood based biomarkers)

    Change from baseline (week 0) on brain-derived neurotrophic factor (BDNF), Glial cell line-derived neurotrophic factor (GDNF), Platelet-derived growth factor (PDGF), Growth/differentiation factor 15 (GDF15) and Epidermal growth factor (EGF) at follow-up (week 104). Optional at week 26, week 52 and week 78. Higher growth factors indicate better function.

    Time frame: Week 0 (baseline), week 26 (optional), week 52 (optional), week 78 (optional) and week 104 (follow-up)

19. Change in ageing mechanism (blood based biomarkers)

    Change from baseline (week 0) on klotho at follow-up (week 104). Optional at week 26, week 52 and week 78. High ageing marker indicate better function (i.e. less aging)

    Time frame: Week 0 (baseline), week 26 (optional), week 52 (optional), week 78 (optional) and week 104 (follow-up)

20. Change in pathological protein (blood based biomarkers)

    Change from baseline (week 0) on α-synuclein at follow-up (week 104). Optional at week 26, week 52 and week 78. Low pathological protein indicate better function (i.e. less pathological process).

    Time frame: Week 0 (baseline), week 26 (optional), week 52 (optional), week 78 (optional) and week 104 (follow-up)

21. Change in neurodegeneration (blood based biomarkers)

    Change from baseline (week 0) on Neurofilament light (NfL) at follow-up (week 104). Optional at week 26, week 52 and week 78. Lower neurodegeneration markers indicate less neurodegeneration.

    Time frame: Week 0 (baseline), week 26 (optional), week 52 (optional), week 78 (optional) and week 104 (follow-up)

22. Change in brain volume (imaging biomarkers)

    Change from baseline (week 0) on T1 Voxel-Based-Morphometry (VBM) at follow-up (week 104). Higher scores indicate higher volume.

    Time frame: Week 0 (baseline) and week 104 (follow-up)

23. Change in white matter hyperintensities (imaging biomarkers)

    Change from baseline (week 0) on FLAIR at follow-up (week 104). Higher scores indicate worse status.

    Time frame: Week 0 (baseline) and week 104 (follow-up)

24. Change in basal ganglia; cortex [1] (imaging biomarkers)

    Change from baseline (week 0) on resting-state functional MRI (Rs-fMRI) at follow-up (week 104). Higher scores indicate better functional connectivity.

    Time frame: Week 0 (baseline) and week 104 (follow-up)

25. Change in basal ganglia; cortex [2] (imaging biomarkers)

    Change from baseline (week 0) on task-based functional MRI at follow-up (week 104). Higher scores indicate better functional connectivity.

    Time frame: Week 0 (baseline) and week 104 (follow-up)

26. Change in substantia nigra [1] (imaging biomarkers)

    Change from baseline (week 0) on diffusion tensor imaging (DTI) at follow-up (week 104). Higher scores indicate better tissue integrity.

    Time frame: Week 0 (baseline) and week 104 (follow-up)

27. Change in substantia nigra [2] (imaging biomarkers)

    Change from baseline (week 0) on Quantitative Susceptibility Mapping (QSM) at follow-up (week 104). Higher scores indicate more iron loading.

    Time frame: Week 0 (baseline) and week 104 (follow-up)

28. Change in substantia nigra [3]; locus coeruleus (imaging biomarkers)

    Change from baseline (week 0) on neuromelanin at follow-up (week 104). Higher scores indicate better tissue integrity.

    Time frame: Week 0 (baseline) and week 104 (follow-up)

29. Change in instrumental activities of daily living (ADL) (functional status)

    Change from baseline (week 0) on Lawton instrumental ADL (iADL) scale at week 52 (1 year) and 104 (follow-up). Range 0-14. Higher score indicate better function.

    Time frame: Week 0 (baseline), week 52 (1 year) and week 104 (follow-up)

30. Change in WHOQoL-BREF (quality of life)

    Change from baseline (week 0) on World Health Organization Quality of Life Questionnaire - BREF (WHOQoL-BREF) scale at week 52 (1 year) and 104 (follow-up). Range 0-100. Higher score indicate better quality of life.

    Time frame: Week 0 (baseline), week 52 (1 year) and week 104 (follow-up)

31. Change in Research and Development (RAND-36)/Short Form health survey (SF-36) (quality of life)

    Change from baseline (week 0) on RAND-36/SF-36 scale at week 52 (1 year) and 104 (follow-up). Range 0-100. Higher score indicate better quality of life.

    Time frame: Week 0 (baseline), week 52 (1 year) and week 104 (follow-up)

32. System Usability (SUS)

    Usability of the Slow-SPEED-NL application assessed by the Dutch version of the System Usability Scale (SUS) at week 52 (year 1) and week 104 (follow-up). Range 0-100. Higher score indicate better usability.

    Time frame: week 104 (follow-up)

33. Barriers and motivators to engage in physical activity

    Barriers and motivators to engage in physical activity reported on a self-developed questionnaire

    Time frame: Week 0 (baseline) and week 104 (follow-up)

34. Change in phenoconversion neurodegenerative disease

    Change from baseline (week 0) on phenoconversion in Parkinson's Disease (PD), Lewy body dementia (LBD) and multiple system atrophy (MSA). Higher scores indicate more phenoconversion.

    Time frame: Week 0 (baseline) and week 104 (follow-up)

35. Change in step count on a group level (compliance)

    Change from week -4 until 0 (baseline period) mean step count per day compared to mean step count in 6 month periods. Mean step count per day will be calculated from 4-week periods. Scored as number of participants able to increase step count per day 0-25%, 26-50%, 51-75%, 76-100% relative to their own baseline measure

    Time frame: Week -4 until 0 (baseline) compared to week 0-26, week 26-52, week 52-78, week 78-104

36. Change in moderate to vigorous physical activity per day on a group level (compliance)

    Change from week -4 until 0 (baseline period) number of minutes exerting (minimally) ≥ 64% of maximum heart rate in 6 month periods. Mean minutes per day will be calculated from 4-week periods. Scored as number of participants to increase 0-25%, 26-50%, 51-75%, 76-100% relative to their own baseline measure

    Time frame: Week -4 until 0 (baseline) compared to week 0-26, week 26-52, week 52-78, week 78-104

37. Number of completed step week goals on a group level (compliance)

    Total number of completed step count week goals

    Time frame: Week 0 (baseline) and week 104 (follow-up)

38. Number of completed aerobic activity (MVPA intensity) week goals on a group level (compliance)

    Total number of completed aerobic activity (MVPA intensity) week goals

    Time frame: Week 0 (baseline) and week 104 (follow-up)

39. Number of drop-outs on a group level (retention rate)

    Number of drop-outs throughout the study

    Time frame: Week 0 (baseline), week 26, week 52, week 78, week 104 (follow-up)

40. Number of interactions with Slow-SPEED app on a group level

    Total times opening the app

    Time frame: Week 0 (baseline), week 26, week 52, week 78, week 104 (follow-up)

41. Number of completed questionnaires on group level (completeness of digital assessments)

    Number of completed questionnaires

    Time frame: Week 0 (baseline), week 52, week 104 (follow-up)

42. Number of smartwatch data points on group level (completeness of digital assessments)

    Number of data points received for each selected smartwatch parameter

    Time frame: Week 0 (baseline), week 26, week 52, week 78, week 104 (follow-up)

43. Total smartwatch wear time on group level (completeness of digital assessments)

    Total smartwatch wear time

    Time frame: Week 0 (baseline), week 26, week 52, week 78, week 104 (follow-up)

44. Number of Roche PD Research mobile application data points on group level (completeness of digital assessments)

    Number of data points received

    Time frame: Week 0 (baseline), week 6, week 12, week 18, week 24, week 30, week 36, week 42, week 48, week 54, week 60, week 66, week 72, week 78, week 84, week 90, week 96, week 102

Publications

• Oosterhof TH, Mitchell E, Ascherio A, Aslibekyan S, Azoidou V, Beasley K, Ben-Shlomo Y, Bunnik E, Carroll C, Chahine L, Corcos D, Janssen Daalen JM, van Dijk KD, Dijkstra BW, Dommershuijsen L, Dorsey R, Evers LJW, Helmich RC, Johansson M, Norcliffe-Kaufmann L, Keavney J, Klein C, Kmiecik MJ, Kustermann T, Macklin EA, Marek K, Meles SK, Overeem S, Philpott CM, Pijpers A, Postuma RB, Rowbotham HM, Schootemeijer S, Schwarzschild MA, Simuni T, Sommerauer M, Stefani A, Steidel K, Verbeek M, van der Vliet R, de Vries NM, van de Warrenburg B, Wyse RK, Bloem BR, Schneider RB, Noyce AJ, Darweesh SKL. Slow-SPEED: protocol for three randomised trials of remotely delivered exercise to prevent Parkinson's disease. NPJ Parkinsons Dis. 2026 Jul 14. doi: 10.1038/s41531-026-01463-z. Online ahead of print. PubMed 42448717 ↗
• Tolosa E, Poewe W, Noyce AJ, Svenningsson P, Mahlknecht P, Marti MJ. Towards biomarker-based diagnosis of Parkinson disease. Nat Rev Neurol. 2026 Mar;22(3):139-151. doi: 10.1038/s41582-026-01185-z. Epub 2026 Feb 13. PubMed 41688680 ↗

Individual participant data

Plan to share: Yes — We will make relevant anonymised data available in a database.

Supporting information: Study protocol

Time frame: We will make relevant anonymised data available in a database after publication of the main results of our trial.

Access criteria: Researchers who are interested in re-use of the data are asked to contact the central contact person for permission.