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

Radboud University Medical Center

Status: Enrolling

Conditions: Parkinson Disease; Movement Disorders

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04848077

NL75501.091.20

Details and patient eligibility

About

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).

Full 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 study is to investigate whether a smartphone app can increase physical activity in PD patients for a long period of time (12 months). The secondary aim is to test the potential group effect on physical fitness, motor- and non-motor symptoms. Thirdly, we aim to investigate whether there is a dose-response relationship between amount of physical activity and physical fitness, motor- and non-motor functioning.

Study design: Double-blind randomized controlled trial.

Study population: A total of 452 Dutch patients with PD who have no other medical conditions that markedly hamper mobility other than PD, 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 to a group that will be motivated to increase their physical activity level to a small, medium, large or very large degree with respect to their own baseline level.

Enrollment: 452 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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)

Exclusion criteria

• 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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452 participants in 4 patient groups

Very high dose

Experimental group

Description:

Very large proportional increase in stepcount relative to baseline stepcount.

Treatment:

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

High dose

Experimental group

Description:

Large proportional increase in stepcount relative to baseline stepcount.

Treatment:

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

Intermediate dose

Experimental group

Description:

Medium proportional increase in stepcount relative to baseline stepcount.

Treatment:

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

Active controls

Active Comparator group

Description:

Small proportional increase in stepcount relative to baseline stepcount.

Treatment:

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