Clinical trial NCT04848077: STEPWISE Parkinson: A Smartphone Based Exercise Solution for Patients With Parkinson's Disease
Official title: STEPWISE Parkinson: A Smartphone Based, Titrated Exercise Solution for Patients With Parkinson's Disease in Daily Life
Study type: INTERVENTIONAL
Overall status: RECRUITING
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
name: Massachusetts General Hospital
name: Hogeschool van Arnhem en Nijmegen (HAN)
name: Canisius-Wilhelmina Hospital
name: IJsfontein Health BV
First posted: 2021-04-19
Enrollment: 452
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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)

Primary outcomes:
measure: Mean change in step count per day
timeFrame: Week -4 until 0 and week 49 until 52
Secondary outcomes:
measure: Change in physical fitness (6MWT)
timeFrame: Week 0 (baseline) and week 53 (follow-up)
measure: Change in motor- and non-motor aspects of daily living
timeFrame: Week 0 (baseline) and week 53 (follow-up)
measure: Change in physical fitness (VO2max)
timeFrame: Week 0 (baseline) and week 53 (follow-up)
measure: Change in Parkinson's Disease symptoms (MDS-UPDRS)
timeFrame: Week 0 (baseline) and week 53 (follow-up)
measure: Change in ambulatory capacity (MDS-UPDRS)
timeFrame: Week 0 (baseline) and week 53 (follow-up)
measure: Change in mobility (TUG)
timeFrame: Week 0 (baseline) and week 53 (follow-up)
measure: Change in balance (Mini-BestTest)
timeFrame: Week 0 (baseline) and week 53 (follow-up)
measure: Change in gait speed (10MWT)
timeFrame: Week 0 (baseline) and week 53 (follow-up)
measure: Change in fear of falling (FES-I)
timeFrame: Week 0 (baseline) and week 53 (follow-up)
measure: Number of falls and near-falls (monthly fall diary)
timeFrame: Every four weeks after start of the intervention (at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 weeks).
measure: Change in handgrip strength
timeFrame: Week 0 (baseline) and week 53 (follow-up)
measure: Change in self-reported physical activity level (LAPAQ)
timeFrame: Week -4 (screening), week 0 (baseline) and week 53 (follow-up)
measure: Change in cognition (MOCA)
timeFrame: Week 0 (baseline) and week 53 (follow-up)
measure: Change in depression and anxiety (HADS)
timeFrame: Week 0 (baseline) and week 53 (follow-up)
measure: Change in apathy (AES-12PD)
timeFrame: Week 0 (baseline) and week 53 (follow-up)
measure: Change in fatigue (FSS)
timeFrame: Week 0 (baseline) and week 53 (follow-up)
measure: Change in severity of sleep problems and daytime sleepiness (SCOPA-SLEEP)
timeFrame: Week 0 (baseline) and week 53 (follow-up)
measure: Change in autonomic dysfunction (SCOPA-AUT)
timeFrame: Week 0 (baseline) and week 53 (follow-up)
measure: Change in Health related quality of life (PDQ-39)
timeFrame: Week 0 (baseline) and week 53 (follow-up)
measure: Perceived effect of intervention (GPE)
timeFrame: At week 53 (follow-up)
measure: System Usability (SUS)
timeFrame: At week 53 (follow-up)
measure: Perceived physical ability (LIVAS)
timeFrame: Week 0 (baseline) and week 53 (follow-up)
Other outcomes:
measure: STEPWISE Parkinson smartphone application data
timeFrame: From baseline (week 0) to follow-up (week 53)
measure: Adherence to the intervention
timeFrame: From baseline (week 0) to follow-up (week 53)
measure: Barriers and motivators to engage in exercise/physical activity at baseline and follow-up
timeFrame: Week 0 (baseline) and week 53 (follow-up)
measure: Exploratory measurement of physical acitivity with wearable sensor
timeFrame: From week 0 (baseline) to week 1 and from week 52 to week 53 (follow-up)
measure: Parkinson's disease symptoms monitored with the mPower app
timeFrame: Every three months from week 0 (baseline) to week 53 (follow-up)
measure: Blood-based biomarkers
timeFrame: Week 0 (baseline) and week 53 (follow-up)
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud university medical center
state: Gelderland
Study officials:
affiliation: Radboudumc Department of Neurology
name: Bastiaan Bloem, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: