An interventional study of Step count increase with the use of a motivational application in Movement Disorders and Parkinson Disease, sponsored by Radboud University Medical Center. Completed at 1 site in Netherlands. Per ClinicalTrials.gov, last updated 2024-11-18.
Sponsored by Radboud University Medical Center · Not applicable, Interventional, and Treatment
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.
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.
325 studies on the registry are indexed under Movement Disorders; 98 are open to participants now.
This study's enrollment of 30 is below the median of 46 across 182 interventional studies indexed under Movement Disorders.
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Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Ten people will be encouraged to increase their physical activity level, measured in step counts on the patients' own smartphone, with 10% compared to their own baseline level.
Behavioral: Step count increase with the use of a motivational application
Ten people will be encouraged to increase their physical activity level, measured in step counts on the patients' own smartphone, with 50% compared to their own baseline level.
Behavioral: Step count increase with the use of a motivational application
Ten people will be encouraged to increase their physical activity level, measured in step counts on the patients' own smartphone, with 100% compared to their own baseline level.
Behavioral: Step count increase with the use of a motivational application
The motivational app will encourage people to increase their physical activity for a short period of time (one month). Different treatment arms will receive different physical activity goals. People will get feedback and be motivated based on their own baseline level and actual activity level.
Change from baseline to the last week of the intervention in step count
Step counts measured continuously with patients' own smartphone
Time frame: Change from baseline to the last week of the intervention (week 4)
Change in PD motor symptoms
Movement Disorders Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) part 3. Range: 0-132. Higher scores indicate worse function.
Time frame: Change from baseline to the post-intervention visit in the first week after week 4 (week 5)
Change in Motor functioning in daily life
Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) part 2. Range: 0-52. Higher scores indicate worse function.
Time frame: Change from baseline to the post-intervention visit in the first week after week 4 (week 5)
Change in Physical fitness
Meters walked during the six minute walk test (6MWT). Higher scores indicate better function.
Time frame: Change from baseline to the post-intervention visit in the first week after week 4 (week 5)
Change in Mobility
Timed Up and Go Test, number of seconds to complete standing up from a chair, walk 3 meters, turn, walk 3 meters back and sit down. Higher scores indicate worse function.
Time frame: Change from baseline to the post-intervention visit in the first week after week 4 (week 5)
Change in Balance
The mini balance evaluation system (mini-BEST) is a 14-item, 3 points ordinal rating scale (0-2 points) to evaluate balance performance in 4 subcategories: anticipatory postural control, reactive postural control, sensory orientation and stability in gait. The attainable scores ranges from 0-28 points, in which a higher score indicates better balance.
Time frame: Change from baseline to the post-intervention visit in the first week after week 4 (week 5)
Change in Gait speed
The ten meter walk test (10MWT) is a standardised and recommended measurement of walking velocity. The number of seconds it takes to walk ten meters is recorded. Higher scores means worse function.
Time frame: Change from baseline to the post-intervention visit in the first week after week 4 (week 5)
Change in Fear of falling
Falls Efficacy Scale International \[FES-I\]. Range: 16-64. Higher score reflects higher fear of falling
Time frame: Change from baseline to the post-intervention visit in the first week after week 4 (week 5)
Change in Handgrip strength
Handgrip strength measured with a dynamometer. Higher scores mean better function.
Time frame: 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
LASA Physical Activity Questionnaire (LAPAQ). Range: 0-no maximum. Higher score reflecting more time spent in physical activities;
Time frame: 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
Movement Disorders Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) part 1. Range: 0-52. Higher scores mean worse function.
Time frame: Change from baseline to the post-intervention visit in the first week after week 4 (week 5)
Change in Cognition
Montreal Cognitive Assessment (MoCA). Range: 0-30. Higher scores reflect better cognition.
Time frame: Change from baseline to post-intervention in the first week after week 4 (week 5)
Change in Depression and anxiety
Hamilton Anxiety and Depression Scale; HADS; Minimum score = 0 (no anxiety or depression), maximum score = 42 (most anxiety or depression). Higher scores mean more anxiety/depression.
Time frame: Change from baseline to the post-intervention visit in the first week after week 4 (week 5)
Change in Apathy
Abbreviated version of the Apathy Evaluaton Scale; AES-12PD. Range 12-48. Higher scores indicate better function.
Time frame: Change from baseline to the post-intervention visit in the first week after week 4 (week 5)
Change in Sleep
Scales for Outcomes in Parkinson's Disease-Sleep; SCOPA-SLEEP. Range: 0-33. Higher scores reflect worse sleep.
Time frame: Change from baseline to the post-intervention visit in the first week after week 4 (week 5)
Change in Autonomic dysfunction
Scales for Outcomes in Parkinson's Disease-Autonomic questionnaire; SCOPA-AUT. Range: 0-69. Higher scores indicate more problems with autonomic function.
Time frame: Change from baseline to the post-intervention visit in the first week after week 4 (week 5)
Change in Health-related quality of life
Parkinson's Disease Questionnaire; PDQ-39. Range: 0-100. Lower scores reflecting a better health-related quality of life
Time frame: Change from baseline to the post-intervention visit in the first week after week 4 (week 5)
System Usability (SUS)
Usability of the STEPWISE application as assessed by the Dutch version of the System Usability Scale (SUS) at 5 weeks (follow-up). Range 0-100. Higher scores indicate better usability.
Time frame: After the post-intervention visit in the first week after week 4 (week 5)
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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