The aim of this pilot study is to investigate whether the developed smartphone app can increase physical activity in PD patients for a short period of time (one month). The secondary aim is to study the usability and enjoyment of the app and theā¦
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
bewegingsstoornis, ziekte van Parkinson
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter will be change in number of steps from baseline to
follow-up (after four weeks), measured with the patients* own smartphone
Secondary outcome
Secondary outcomes will be usability and enjoyment of the application and
different measures of physical fitness, motor- and non-motor functioning.
Background summary
Exercise affords health benefits for patients with Parkinson*s disease (PD),
but implementing exercise in daily life remains challenging. We recently showed
that PD patients can adhere to a 6 month high-intensity exercise training
program on a stationary bicycle at home and found a higher aerobic capacity and
improved motor symptoms after the training program. However, such a training
program is not very scalable. We take an important step forward by developing
and studying an innovative and fully decentralized smartphone-based program to
increase long-term physical activity in patients with PD in daily life.
Study objective
The aim of this pilot study is to investigate whether the developed smartphone
app can increase physical activity in PD patients 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 controlled intervention study.
Intervention
Patients 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 patients* 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.
Study burden and risks
The motivational application is non-invasive and the risks associated with
participation in this project is negligible. Patients with PD will use the
application at home for a time period of four weeks. The interventional groups
will be encouraged to become substantially more active (ie. Take 50% or 100%
more steps than at baseline) and one group will be encouraged to only slightly
increase their physical activity level (ie. Take 10% more steps than at
baseline). At baseline and after four weeks, PD patients will visit the Radboud
University Medical Centre for measurements and PD patients and their caregivers
will fill in a questionnaire and will be interviewed by telephone. This will
take approximately 3-4 hours. All tests will be performed in the medication on
state. Travel expenses will be reimbursed.
Reinier Postlaan 4 (route 914)
Nijmegen 6500 HB
NL
Reinier Postlaan 4 (route 914)
Nijmegen 6500 HB
NL
Listed location countries
Age
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 outdoor and/or sports activities per day (LASA
Physical Activity Questionnaire (LAPAQ))
6) takes less than 7.000 steps/day during 1-week baseline
Exclusion criteria
1) weekly falls in the previous 3 months
3) medical conditions that hamper mobility
4) living in a nursing home
5) cognitive impairments that hamper use of the motivational app on the
smartphone (Montreal Cognitive Assessment <26)
6) not in the possession of a suitable smartphone (Iphone or Android)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL74352.091.20 |