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

Last updated: February 23, 2023
Sponsor: Radboud University Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dyskinesias

Tardive Dyskinesia

Tic Disorders

Treatment

N/A

Clinical Study ID

NCT04848077
NL75501.091.20
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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 5-28LASA Physical Activity Questionnaire (LAPAQ))
  • less than 7,000 steps/day during 1-month baseline (week -4 until 0)

Exclusion

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 evaluationby the assessor)
  • not in the possession of a suitable smartphone (Iphone 5S or newer with iOS 10 orhigher or Android 4.1 or newer)

Study Design

Total Participants: 452
Study Start date:
May 18, 2021
Estimated Completion Date:
July 31, 2026

Study 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.

Connect with a study center

  • Radboud university medical center

    Nijmegen, Gelderland 6500 HB
    Netherlands

    Active - Recruiting

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