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Completed

NCT Number: NCT06692387

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.

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Key information

Conditions

Movement Disorders Basal Ganglia Diseases Behavior Brain Diseases Central Nervous System Diseases Motor Activity Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Radboud university medical center

Nijmegen, Gelderland, 6500 HB, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Step count increase with the use of a motivational application

Behavioral

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.

Primary outcomes

  1. Change from baseline to the last week of the intervention in step count

    Time frame: Change from baseline to the last week of the intervention (week 4)

    Step counts measured continuously with patients' own smartphone

Secondary outcomes

  1. Change in PD motor symptoms

    Time frame: Change from baseline to the post-intervention visit in the first week after week 4 (week 5)

    Movement Disorders Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) part 3. Range: 0-132. Higher scores indicate worse function.

  2. Change in Motor functioning in daily life

    Time frame: Change from baseline to the post-intervention visit in the first week after week 4 (week 5)

    Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) part 2. Range: 0-52. Higher scores indicate worse function.

  3. Change in Physical fitness

    Time frame: Change from baseline to the post-intervention visit in the first week after week 4 (week 5)

    Meters walked during the six minute walk test (6MWT). Higher scores indicate better function.

  4. Change in Mobility

    Time frame: Change from baseline to the post-intervention visit in the first week after week 4 (week 5)

    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.

  5. Change in Balance

    Time frame: Change from baseline to the post-intervention visit in the first week after week 4 (week 5)

    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.

  6. Change in Gait speed

    Time frame: Change from baseline to the post-intervention visit in the first week after week 4 (week 5)

    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.

  7. Change in Fear of falling

    Time frame: Change from baseline to the post-intervention visit in the first week after week 4 (week 5)

    Falls Efficacy Scale International [FES-I]. Range: 16-64. Higher score reflects higher fear of falling

  8. Change in Handgrip strength

    Time frame: Change from baseline to post-intervention in the first week after week 4 (week 5)

    Handgrip strength measured with a dynamometer. Higher scores mean better function.

  9. Change from baseline to post-intervention after week 4 in Self-reported physical activity level

    Time frame: Change from baseline to the post-intervention visit in the first week after week 4 (week 5)

    LASA Physical Activity Questionnaire (LAPAQ). Range: 0-no maximum. Higher score reflecting more time spent in physical activities;

  10. Change from baseline to post-intervention after week 4 in Global PD non-motor symptoms

    Time frame: Change from baseline to the post-intervention visit in the first week after week 4 (week 5)

    Movement Disorders Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) part 1. Range: 0-52. Higher scores mean worse function.

  11. Change in Cognition

    Time frame: Change from baseline to post-intervention in the first week after week 4 (week 5)

    Montreal Cognitive Assessment (MoCA). Range: 0-30. Higher scores reflect better cognition.

  12. Change in Depression and anxiety

    Time frame: Change from baseline to the post-intervention visit in the first week after week 4 (week 5)

    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.

  13. Change in Apathy

    Time frame: Change from baseline to the post-intervention visit in the first week after week 4 (week 5)

    Abbreviated version of the Apathy Evaluaton Scale; AES-12PD. Range 12-48. Higher scores indicate better function.

  14. Change in Sleep

    Time frame: Change from baseline to the post-intervention visit in the first week after week 4 (week 5)

    Scales for Outcomes in Parkinson's Disease-Sleep; SCOPA-SLEEP. Range: 0-33. Higher scores reflect worse sleep.

  15. Change in Autonomic dysfunction

    Time frame: Change from baseline to the post-intervention visit in the first week after week 4 (week 5)

    Scales for Outcomes in Parkinson's Disease-Autonomic questionnaire; SCOPA-AUT. Range: 0-69. Higher scores indicate more problems with autonomic function.

  16. Change in Health-related quality of life

    Time frame: Change from baseline to the post-intervention visit in the first week after week 4 (week 5)

    Parkinson's Disease Questionnaire; PDQ-39. Range: 0-100. Lower scores reflecting a better health-related quality of life

Other outcomes

  1. System Usability (SUS)

    Time frame: After the post-intervention visit in the first week after week 4 (week 5)

    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.

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Official study title

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

Acronym: STEPWISE

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 18, 2024
Registry last updated
Nov 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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