Clinical Trials Directory

Trials / Completed

CompletedNCT06692387

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
30 (actual)
Sponsor
Radboud University Medical Center · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALStep count increase with the use of a motivational applicationThe 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.

Timeline

Start date
2020-11-02
Primary completion
2021-04-01
Completion
2021-04-01
First posted
2024-11-18
Last updated
2024-11-18

Locations

1 site across 1 country: Netherlands

Source: ClinicalTrials.gov record NCT06692387. Inclusion in this directory is not an endorsement.