A Smartphone Based, Titrated Exercise Solution for Patients With Parkinson's Disease in Daily Life: Pilot Study (STEPWISE)

STEPWISE Parkinson: A Smartphone Based, Titrated Exercise Solution for Patients With Parkinson's Disease in Daily Life - Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease; Movement Disorders
• Intervention / Treatment: Behavioral: Step count increase with the use of a motivational application

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6500 HB
      • Radboud University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active control group; 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; 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.
Experimental: Step count increase 50%; 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; 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.
Experimental: Step count increase 100%; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline to the last week of the intervention in step count	Step counts measured continuously with patients' own smartphone	Change from baseline to the last week of the intervention (week 4)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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	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.	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;	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.	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.	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.	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.	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.	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.	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	Change from baseline to the post-intervention visit in the first week after week 4 (week 5)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	After the post-intervention visit in the first week after week 4 (week 5)

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2020
• Primary Completion (Actual): April 1, 2021
• Study Completion (Actual): April 1, 2021

Study Registration Dates

• First Submitted: July 3, 2020
• First Submitted That Met QC Criteria: November 14, 2024
• First Posted (Estimated): November 18, 2024

Study Record Updates

• Last Update Posted (Estimated): November 18, 2024
• Last Update Submitted That Met QC Criteria: November 14, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Exercise; Physical activity; Parkinson Disease; Walking; Locomotion; Motivational application
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Parkinson Disease
• Other Study ID Numbers: NL74352.091.20

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No