STEPWISE Parkinson: A Smartphone Based Exercise Solution for Patients With Parkinson's Disease

NCT04848077 | Recruiting DMC

• 1 other identifier: NL75501.091.20
• Study Type: interventional
• Target: 452
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Movement Disorders; Parkinson Disease

Keywords

Physical activity; Walking; Exercise; Parkinson Disease; Locomotion; Motivational application

Outcome Measures

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).

  Week -4 until 0 and week 49 until 52

Secondary Outcomes (22)

• Change in physical fitness (6MWT)

  Week 0 (baseline) and week 53 (follow-up)

• Change in motor- and non-motor aspects of daily living

  Week 0 (baseline) and week 53 (follow-up)

• Change in physical fitness (VO2max)

  Week 0 (baseline) and week 53 (follow-up)

• Change in Parkinson's Disease symptoms (MDS-UPDRS)

  Week 0 (baseline) and week 53 (follow-up)

• Change in ambulatory capacity (MDS-UPDRS)

  Week 0 (baseline) and week 53 (follow-up)

Other Outcomes (6)

• STEPWISE Parkinson smartphone application data

  From baseline (week 0) to follow-up (week 53)

• Adherence to the intervention

  From baseline (week 0) to follow-up (week 53)

• Barriers and motivators to engage in exercise/physical activity at baseline and follow-up

  Week 0 (baseline) and week 53 (follow-up)

Study Arms (4)

Very high dose

EXPERIMENTAL

Very large proportional increase in stepcount relative to baseline stepcount.

Behavioral: Step count increase with the use of a motivational smartphone application

High dose

EXPERIMENTAL

Large proportional increase in stepcount relative to baseline stepcount.

Behavioral: Step count increase with the use of a motivational smartphone application

Intermediate dose

EXPERIMENTAL

Medium proportional increase in stepcount relative to baseline stepcount.

Behavioral: Step count increase with the use of a motivational smartphone application

Active controls

ACTIVE COMPARATOR

Small proportional increase in stepcount relative to baseline stepcount.

Behavioral: Step count increase with the use of a motivational smartphone application

Interventions

Step count increase with the use of a motivational smartphone application BEHAVIORAL

All 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).

Active controls; High dose; Intermediate dose; Very high dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: 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
• equal to or less than 120 minutes of sports/outdoor activities per day (question 5-28 LASA Physical Activity Questionnaire (LAPAQ))
• less than 7,000 steps/day during 1-month baseline (week -4 until 0)

You may not qualify if:

• 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)
• not in the possession of a suitable smartphone (Iphone 5S or newer with iOS 10 or higher or Android 4.1 or newer)

Sponsors & Collaborators

• Radboud University Medical Center: lead
• 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

Study Sites (1)

Radboud university medical center

Nijmegen, Gelderland, 6500 HB, Netherlands

RECRUITING

Related Publications (1)

• Schootemeijer S, de Vries NM, Macklin EA, Roes KCB, Joosten H, Omberg L, Ascherio A, Schwarzschild MA, Bloem BR. The STEPWISE study: study protocol for a smartphone-based exercise solution for people with Parkinson's Disease (randomized controlled trial). BMC Neurol. 2023 Sep 12;23(1):323. doi: 10.1186/s12883-023-03355-8.

  PMID: 37700241 DERIVED

MeSH Terms

Conditions

Movement Disorders; Parkinson Disease; Motor Activity

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Synucleinopathies; Neurodegenerative Diseases; Behavior

Study Officials

• Bastiaan Bloem, Prof. Dr.

  Radboudumc Department of Neurology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sabine Schootemeijer, MSc

CONTACT

00316 50155754; sabine.schootemeijer@radboudumc.nl

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: April 13, 2021
• First Posted: April 19, 2021
• Study Start: May 18, 2021
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 20, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After publication of the main results of our trial.
• Access Criteria: Access to the data is restricted, meaning that researchers who are interested in re-use of the data are asked to contact the central contact person for permission. Approval is given after a signed agreement.

Locations

NL (1)