NCT04848077

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 452 (estimated)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

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

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2021-05-18
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2021-04-19
• Last updated: 2025-04-20

Locations

1 site across 1 country: Netherlands