Clinical trial NCT06692387: A Smartphone Based, Titrated Exercise Solution for Patients With Parkinson's Disease in Daily Life: Pilot Study
Official title: STEPWISE Parkinson: A Smartphone Based, Titrated Exercise Solution for Patients With Parkinson's Disease in Daily Life - Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Movement Disorders
Parkinson Disease
Keywords: Physical activity
Walking
Exercise
Parkinson Disease
Locomotion
Motivational application
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2024-11-18
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. idiopathic PD
2. Hoehn and Yahr 1-3
3. able to understand the Dutch language
4. able to walk independently
5. less than 30 minutes of sports/outdoor activities per day (LASA Physical Activity Questionnaire, LAPAQ)
6. less than 7,000 steps/day during 1-week baseline

Exclusion Criteria:

1. weekly falls in the previous 3 months
2. medical conditions that hamper mobility
3. living in a nursing home
4. cognitive impairments that hamper use of the motivational app on the smartphone (Montreal Cognitive Assessment, MoCA \<26)
5. not in the possession of a suitable smartphone (Iphone 5S or newer with iOS 10 or higher or Android 4.1 or newer)

Primary outcomes:
measure: Change from baseline to the last week of the intervention in step count
timeFrame: Change from baseline to the last week of the intervention (week 4)
Secondary outcomes:
measure: Change in PD motor symptoms
timeFrame: Change from baseline to the post-intervention visit in the first week after week 4 (week 5)
measure: Change in Motor functioning in daily life
timeFrame: Change from baseline to the post-intervention visit in the first week after week 4 (week 5)
measure: Change in Physical fitness
timeFrame: Change from baseline to the post-intervention visit in the first week after week 4 (week 5)
measure: Change in Mobility
timeFrame: Change from baseline to the post-intervention visit in the first week after week 4 (week 5)
measure: Change in Balance
timeFrame: Change from baseline to the post-intervention visit in the first week after week 4 (week 5)
measure: Change in Gait speed
timeFrame: Change from baseline to the post-intervention visit in the first week after week 4 (week 5)
measure: Change in Fear of falling
timeFrame: Change from baseline to the post-intervention visit in the first week after week 4 (week 5)
measure: Change in Handgrip strength
timeFrame: Change from baseline to post-intervention in the first week after week 4 (week 5)
measure: Change from baseline to post-intervention after week 4 in Self-reported physical activity level
timeFrame: Change from baseline to the post-intervention visit in the first week after week 4 (week 5)
measure: Change from baseline to post-intervention after week 4 in Global PD non-motor symptoms
timeFrame: Change from baseline to the post-intervention visit in the first week after week 4 (week 5)
measure: Change in Cognition
timeFrame: Change from baseline to post-intervention in the first week after week 4 (week 5)
measure: Change in Depression and anxiety
timeFrame: Change from baseline to the post-intervention visit in the first week after week 4 (week 5)
measure: Change in Apathy
timeFrame: Change from baseline to the post-intervention visit in the first week after week 4 (week 5)
measure: Change in Sleep
timeFrame: Change from baseline to the post-intervention visit in the first week after week 4 (week 5)
measure: Change in Autonomic dysfunction
timeFrame: Change from baseline to the post-intervention visit in the first week after week 4 (week 5)
measure: Change in Health-related quality of life
timeFrame: Change from baseline to the post-intervention visit in the first week after week 4 (week 5)
Other outcomes:
measure: System Usability (SUS)
timeFrame: After the post-intervention visit in the first week after week 4 (week 5)
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud university medical center
state: Gelderland
Study officials:
References: