STEPWISE Parkinson: A Smartphone Based Exercise Solution for Patients With Parkinson's Disease

Browse trials for

• Parkinson Disease 4,487
• Movement Disorders 320

Keywords

• Physical activity
• Walking
• Exercise
• Parkinson Disease
• Locomotion
• Motivational application

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's planned enrollment of 452 is above the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.

Lead sponsor

Radboud University Medical Center is the lead sponsor of 959 studies on the registry; 134 are open to participants now.

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

Study arms

• Experimental
  Very high dose

  Very large proportional increase in stepcount relative to baseline stepcount.

  Behavioral: Step count increase with the use of a motivational smartphone application

• Experimental
  High dose

  Large proportional increase in stepcount relative to baseline stepcount.

  Behavioral: Step count increase with the use of a motivational smartphone application

• Experimental
  Intermediate dose

  Medium proportional increase in stepcount relative to baseline stepcount.

  Behavioral: Step count increase with the use of a motivational smartphone application

• Active comparator
  Active controls

  Small proportional increase in stepcount relative to baseline stepcount.

  Behavioral: Step count increase with the use of a motivational smartphone application

Interventions

• BehavioralStep count increase with the use of a motivational smartphone application

  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).

Primary outcomes

1. 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).

   Time frame: Week -4 until 0 and week 49 until 52

Secondary outcomes

1. 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.

   Time frame: Week 0 (baseline) and week 53 (follow-up)

2. 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.

   Time frame: Week 0 (baseline) and week 53 (follow-up)

3. 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.

   Time frame: Week 0 (baseline) and week 53 (follow-up)

4. 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.

   Time frame: Week 0 (baseline) and week 53 (follow-up)

5. 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.

   Time frame: Week 0 (baseline) and week 53 (follow-up)

6. 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.

   Time frame: Week 0 (baseline) and week 53 (follow-up)

7. 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.

   Time frame: Week 0 (baseline) and week 53 (follow-up)

8. 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.

   Time frame: Week 0 (baseline) and week 53 (follow-up)

9. 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.

   Time frame: Week 0 (baseline) and week 53 (follow-up)

10. 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.

    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).

11. Change in handgrip strength

    Change from baseline in hand grip strength (kg) as assessed with a dynamometer (best out of three attempts).

    Time frame: Week 0 (baseline) and week 53 (follow-up)

12. 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.

    Time frame: Week -4 (screening), week 0 (baseline) and week 53 (follow-up)

13. 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.

    Time frame: Week 0 (baseline) and week 53 (follow-up)

14. 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.

    Time frame: Week 0 (baseline) and week 53 (follow-up)

15. 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.

    Time frame: Week 0 (baseline) and week 53 (follow-up)

16. 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.

    Time frame: Week 0 (baseline) and week 53 (follow-up)

17. 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).

    Time frame: Week 0 (baseline) and week 53 (follow-up)

18. 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).

    Time frame: Week 0 (baseline) and week 53 (follow-up)

19. 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.

    Time frame: Week 0 (baseline) and week 53 (follow-up)

20. 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.

    Time frame: At week 53 (follow-up)

21. 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.

    Time frame: At week 53 (follow-up)

22. 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.

    Time frame: Week 0 (baseline) and week 53 (follow-up)

Other outcomes

1. STEPWISE Parkinson smartphone application data

   User data from the STEPWISE smartphone application will be collected, including number of interactions with the app and the total time the application was used.

   Time frame: From baseline (week 0) to follow-up (week 53)

2. Adherence to the intervention

   Adherence to the study intervention as indicated by the number of days the STEPWISE app was used.

   Time frame: From baseline (week 0) to follow-up (week 53)

3. Barriers and motivators to engage in exercise/physical activity at baseline and follow-up

   Barriers and motivators to engage in exercise/physical activity reported on the self-developed Barriers and Motivators questionnaire at week 0 (baseline) and week 53 (follow-up).

   Time frame: Week 0 (baseline) and week 53 (follow-up)

4. Exploratory measurement of physical acitivity with wearable sensor

   Movement data captured with a 6-axis inertial movement sensor (Axivity AX6).

   Time frame: From week 0 (baseline) to week 1 and from week 52 to week 53 (follow-up)

5. Parkinson's disease symptoms monitored with the mPower app

   Parkinson's disease symptoms monitored remotely with the mPower smartphone app.

   Time frame: Every three months from week 0 (baseline) to week 53 (follow-up)

6. Blood-based biomarkers

   Change in blood-based biomarkers. Assays will be determined before unblinding. Collected for a subgroup of participants (maximum n=135).

   Time frame: Week 0 (baseline) and week 53 (follow-up)

Study documents

• Statistical analysis plan · Aug 8, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

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

Supporting information: Study protocol, Sap