STEPWISE Parkinson: A Smartphone Based, Titrated Exercise Solution for Patients With Parkinson's Disease in Daily Life - Pilot Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Movement Disorders
- Sponsor
- Radboud University Medical Center
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Change from baseline to the last week of the intervention in step count
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The aim of this pilot randomized controlled trial is to test whether it's feasible to increase participants' step counts within four weeks with a developed motivational smartphone application. If this is feasible, then we can proceed to test the app in a large, long-term randomized clinical trial.
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 pilot study is to investigate whether the developed smartphone app can increase physical activity in people with PD for a short period of time (one month). The secondary aim is to study the usability and enjoyment of the app and the potential effects of an increase in physical activity on physical fitness, motor- and non-motor functioning. Study design: Pilot double-blind randomized controlled intervention study. Study population: A total of 30 Dutch people with PD who have no other medical conditions that markedly hamper mobility, 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 into one of three groups. All groups will be encouraged to increase their physical activity level, measured in step counts on the participants' own smartphone, with a different percentage: (a) an increase in step count of 10% (active control group, N = 10), (b) in increase in step count of 50% (experimental group 1, N = 10), or (c) an increase in step count of 100% (experimental group 2, N = 10), compared to their baseline level.
Investigators
Eligibility Criteria
Inclusion Criteria
- •idiopathic PD
- •Hoehn and Yahr 1-3
- •able to understand the Dutch language
- •able to walk independently
- •less than 30 minutes of sports/outdoor activities per day (LASA Physical Activity Questionnaire, LAPAQ)
- •less than 7,000 steps/day during 1-week baseline
Exclusion Criteria
- •weekly falls in the previous 3 months
- •medical conditions that hamper mobility
- •living in a nursing home
- •cognitive impairments that hamper use of the motivational app on the smartphone (Montreal Cognitive Assessment, MoCA \<26)
- •not in the possession of a suitable smartphone (Iphone 5S or newer with iOS 10 or higher or Android 4.1 or newer)
Outcomes
Primary Outcomes
Change from baseline to the last week of the intervention in step count
Time Frame: Change from baseline to the last week of the intervention (week 4)
Step counts measured continuously with patients' own smartphone
Secondary Outcomes
- Change in PD motor symptoms(Change from baseline to the post-intervention visit in the first week after week 4 (week 5))
- Change in Motor functioning in daily life(Change from baseline to the post-intervention visit in the first week after week 4 (week 5))
- Change in Physical fitness(Change from baseline to the post-intervention visit in the first week after week 4 (week 5))
- Change in Mobility(Change from baseline to the post-intervention visit in the first week after week 4 (week 5))
- Change in Health-related quality of life(Change from baseline to the post-intervention visit in the first week after week 4 (week 5))
- Change in Balance(Change from baseline to the post-intervention visit in the first week after week 4 (week 5))
- Change in Gait speed(Change from baseline to the post-intervention visit in the first week after week 4 (week 5))
- Change in Fear of falling(Change from baseline to the post-intervention visit in the first week after week 4 (week 5))
- Change in Handgrip strength(Change from baseline to post-intervention in the first week after week 4 (week 5))
- Change from baseline to post-intervention after week 4 in Self-reported physical activity level(Change from baseline to the post-intervention visit in the first week after week 4 (week 5))
- Change from baseline to post-intervention after week 4 in Global PD non-motor symptoms(Change from baseline to the post-intervention visit in the first week after week 4 (week 5))
- Change in Cognition(Change from baseline to post-intervention in the first week after week 4 (week 5))
- Change in Depression and anxiety(Change from baseline to the post-intervention visit in the first week after week 4 (week 5))
- Change in Apathy(Change from baseline to the post-intervention visit in the first week after week 4 (week 5))
- Change in Sleep(Change from baseline to the post-intervention visit in the first week after week 4 (week 5))
- Change in Autonomic dysfunction(Change from baseline to the post-intervention visit in the first week after week 4 (week 5))