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

Study Overview
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Brief Summary
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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
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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.

Official Title
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STEPWISE Parkinson: A Smartphone Based, Titrated Exercise Solution for Patients With Parkinson's Disease in Daily Life

Conditions
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Movement Disorders, Parkinson Disease

Intervention / Treatment
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* Behavioral: Step count increase with the use of a motivational smartphone application


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Very high dose<br>Very large proportional increase in stepcount relative to baseline stepcount. | Behavioral: Step count increase with the use of a motivational smartphone application<br>* 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).<br>|
| Experimental: High dose<br>Large proportional increase in stepcount relative to baseline stepcount. | Behavioral: Step count increase with the use of a motivational smartphone application<br>* 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).<br>|
| Experimental: Intermediate dose<br>Medium proportional increase in stepcount relative to baseline stepcount. | Behavioral: Step count increase with the use of a motivational smartphone application<br>* 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).<br>|
| Active Comparator: Active controls<br>Small proportional increase in stepcount relative to baseline stepcount. | Behavioral: Step count increase with the use of a motivational smartphone application<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Week -4 until 0 and week 49 until 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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. | 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. | 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. | 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. | 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. | 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). | 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). | 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. | 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. | 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. | 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. | Week 0 (baseline) and week 53 (follow-up) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical activity, Walking, Exercise, Parkinson Disease, Locomotion, Motivational application