Effectiveness of an Active Lifestyle Promotion Program for Patients with Parkinson*s disease; The ParkFit study

Patients with Parkinson*s disease (PD) are heavily inclined towards a sedentary
lifestyle. This is caused by a combination of physical impairments and
cognitive dysfunction. However, regular physical activity in PD is highly
desirable, for two reasons. First, physical activity has positive generic
effects in preventing complications such as cardiovascular diseases, type II
diabetes mellitus, osteoporosis and certain cases of cancer. Second, physical
activity has additional disease-specific merits in PD such as depression, sleep
disturbances and constipation. These effects lead to raised quality of life.
Furthermore, animal studies suggest that physical activity could slow down
disease progression.
The first aim of the ParkFit-study is to investigate if a exercise-program
results in a meaningful improvement in physical activity levels during two
years in patients with PD with a sedentary lifestyle. Second, the
disease-specific health benefits of improved physical activity will be
determined.
During a period of two years, patients are referred to a physical therapist
with specific exercise in PD. These physical therapists are educated and
trained in the past two years (The ParkNet trial). In the ParkFit-study,
physical therapists will be specifically trained as a ParkFit-therapist. Next
to sport-specific information, special attention will be given to motivational
interviewing and the coaching of sedentary patients.
A PD-specific physical promotion program will be developed as a principle for
the intervention. Signing a Health Contract will be added to the intervention.
The contract includes motivation strategies, goal setting, social support,
memory techniques and problem solving techniques. Besides, each patient
receives a pedometer as a motivational and feedback tool.
Weekly participation in a Parkinson exercise group is also part of the
intervention. These exercise groups are formed in order to experience effects
of physical activity in a controlled and supervised situation.
Seven hundred patients with PD will be enrolled in the study. Patients will be
randomly assigned to the experimental group or the control group. In the
control group, patients will receive ParkinsonNet physical therapy. After 6, 12
and 24 months the effects will be measured by standardized questionnaires and a
test for physical fitness.
In order to try to investigate genetic variations in responsible growth factors
for neuroplasticity, patients have to give one blood sample.

First aim of the study is to investigate whether a physical activity promotion
program will result in a improvement in physical activity in sedentary patients
with PD. Furthermore, the related health benefits will be analysed.

Multicentre randomised controlled trial

The intervention has four key elements:
- Personal Activity Coach (the ParkFit-therapist) for counseling and motivating
the patient
- Health Contract between coach and patient which leads to a Personal Activity
Plan
- Exercise group sessions
Year 1
Month 1-3: two times per week exercise group
Month 4-12: one time per week exercise group
Year 2
Month 1-3: two times per week exercise group
Month 4-12: one time per week exercise group
- Pedometer as an individual motivational and feedback tool

During the study, measurements will take place at baseline, and after 6, 12 and
24 months. Measurements will be performed in a local hospital or sports hall.
For the once-only venapuncture, patients can visit the polyclinic of the
participating hospital in the patients' neighbourhood.

In the experimental group, physical therapists with specific expertise in
activity coaching and in PD will take care over the patients. However, also in
daily life patients will be supported towards an active lifestyle which is not
possible without investing in time and energy. The sport exercise group is time
consuming but we are convinced that offering sport groups will be very
motivating and supporting. Next to exercise, attention will be paid to
motivational strategies and patients can motivate and help each other.
The risks of an improved level of physical activity are at first an increased
risk of (sport-)injuries. Furthermore, patients who are more physically active
are in a higher risk of falling. However, these possible risks are minimal and
in our opinion no contra-indication for participating in the study, for
example because of the intensive counseling. The risks to and burdens for the
patients are also extensively described in the research protocol.