STEPWISE Parkinson: A Smartphone Based Exercise Solution for Patients With Parkinson's Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Step count increase with the use of a motivational smartphone application.
- Who it may be relevant to
- Registry conditions: Movement Disorders, Parkinson Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
STEPWISE Parkinson: A Smartphone Based, Titrated Exercise Solution for Patients With Parkinson's Disease in Daily Life
Overview
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.
Interventions
- Behavioral Step 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 outcome measures
- Mean change in step count per day [Time frame: Week -4 until 0 and week 49 until 52]
Secondary outcome measures (12)
- 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)]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Netherlands · 1 center
- Radboud university medical center — Nijmegen
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. PMID 37700241
Identifiers
NCT: NCT04848077 · NL75501.091.20