NCT06692387

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 3, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

November 2, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
3.6 years until next milestone

First Posted

Study publicly available on registry

November 18, 2024

Completed
Last Updated

November 18, 2024

Status Verified

November 1, 2024

Enrollment Period

5 months

First QC Date

July 3, 2020

Last Update Submit

November 14, 2024

Conditions

Movement DisordersParkinson Disease

Keywords

Physical activityWalkingExerciseParkinson DiseaseLocomotionMotivational application

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (16)

  • Change in PD motor symptoms

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

  • Change in Motor functioning in daily life

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

  • Change in Physical fitness

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

  • Change in Mobility

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

  • Change in Balance

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

  • +11 more secondary outcomes

Other Outcomes (1)

  • System Usability (SUS)

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

Study Arms (3)

Active control group

ACTIVE COMPARATOR

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

Step count increase 50%

EXPERIMENTAL

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

Step count increase 100%

EXPERIMENTAL

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

Interventions

Step count increase with the use of a motivational applicationBEHAVIORAL

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.

Active control groupStep count increase 100%Step count increase 50%

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud university medical center

Nijmegen, Gelderland, 6500 HB, Netherlands

Location

MeSH Terms

Conditions

Movement DisordersParkinson DiseaseMotor Activity

Condition Hierarchy (Ancestors)

Central Nervous System DiseasesNervous System DiseasesParkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesSynucleinopathiesNeurodegenerative DiseasesBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2020

First Posted

November 18, 2024

Study Start

November 2, 2020

Primary Completion

April 1, 2021

Study Completion

April 1, 2021

Last Updated

November 18, 2024

Record last verified: 2024-11

Locations

NL(1)