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

Radboud University Medical Center

Status: Completed

Conditions: Parkinson Disease; Movement Disorders

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06692387

NL74352.091.20

Details and patient eligibility

About

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.

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 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.

Enrollment: 30 patients

Sex: All

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 3 patient groups

Active control group

Active Comparator group

Description:

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.

Treatment:

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

Step count increase 50%

Experimental group

Description:

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.

Treatment:

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

Step count increase 100%

Experimental group

Description:

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.

Treatment:

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