STEPWISE Parkinson: A Smartphone Based Exercise Solution for Patients With Parkinson's Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRadboud University Medical Center
About this trial
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
This trial does not accept healthy volunteersQualifiers
idiopathic PD
Hoehn and Yahr 1-3
able to understand the Dutch language
able to walk independently
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Step count increase with the use of a motivational smartphone application
BehavioralAll 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).
Treatment groups
452 Participants
are divided into 4 treatment groupsGroup A: Very high doseExperimental treatment 1 intervention
Group B: High doseExperimental treatment 1 intervention
Group C: Intermediate doseExperimental treatment 1 intervention
Group D: Active controlsActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Mean change in step count per day
Mean change in step count per day as measured continuously with the participant's smartphone from baseline (week -4 to 0) to follow-up (week 49-52). Higher scores indicate more physical activity (steps).
Time frame
Week -4 until 0 and week 49 until 52Secondary outcomes
1
Change in physical fitness (6MWT)
Change from baseline in meters walked during the six minute walk test (6MWT) at week 53 (follow-up). Higher scores indicate better function.
Time frame
Week 0 (baseline) and week 53 (follow-up)2
Change in motor- and non-motor aspects of daily living
Change from baseline in the Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) parts Ib and II at 53 weeks (follow-up). Range 0-80. Higher scores indicate worse function.
Time frame
Week 0 (baseline) and week 53 (follow-up)3
Change in physical fitness (VO2max)
Change from baseline in VO2max in ml/kg/min assessed by a maximal aerobic exercise test on a cycle ergometer at follow-up (week 53). Higher scores indicate better function. Performed in a subgroup of 100 participants.
Time frame
Week 0 (baseline) and week 53 (follow-up)4
Change in Parkinson's Disease symptoms (MDS-UPDRS)
Change from baseline in the Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) at 53 weeks (follow-up). Range 0-199. Higher scores indicate worse function. Total scores for Parts I, II, III, and IV will also be calculated.
Time frame
Week 0 (baseline) and week 53 (follow-up)Other outcomes
1
STEPWISE Parkinson smartphone application data
User data from the STEPWISE smartphone application will be collected, including number of interactions with the app and the total time the application was used.
Time frame
From baseline (week 0) to follow-up (week 53)2
Adherence to the intervention
Adherence to the study intervention as indicated by the number of days the STEPWISE app was used.
Time frame
From baseline (week 0) to follow-up (week 53)3
Barriers and motivators to engage in exercise/physical activity at baseline and follow-up
Barriers and motivators to engage in exercise/physical activity reported on the self-developed Barriers and Motivators questionnaire at week 0 (baseline) and week 53 (follow-up).
Time frame
Week 0 (baseline) and week 53 (follow-up)4
Exploratory measurement of physical acitivity with wearable sensor
Movement data captured with a 6-axis inertial movement sensor (Axivity AX6).
Time frame
From week 0 (baseline) to week 1 and from week 52 to week 53 (follow-up)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Radboud University Medical Center
Lead sponsor
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborator
Massachusetts General Hospital
Collaborator
Hogeschool van Arnhem en Nijmegen (HAN)
Collaborator
Canisius-Wilhelmina Hospital
Collaborator
IJsfontein Health BV
Collaborator
Source ClinicalTrials.gov