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Effectiveness of an Active Lifestyle Promotion Program for Patients With Parkinson's Disease

The ParkFit Study; Effectiveness of an Active Lifestyle Promotion Program for Patients With Parkinson's Disease

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00748488
Acronym
ParkFit
Enrollment
700
Registered
2008-09-08
Start date
2008-09-30
Completion date
2011-12-31
Last updated
2012-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

Keywords

Parkinson, Physical Therapy, Physical Activity

Brief summary

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. Secondly, 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. Simply informing patients about the importance of physical activity is not enough to initiate and maintain an adequate level of physical activity. We propose to develop a physical activity promoting program for sedentary patients with PD in order to raise their level of daily physical activity. Objective: The first aim of the study is to investigate whether a physical activity promotion program will result in an increase in physical activity in sedentary patients with PD. The second aim is to demonstrate an increase in physical fitness and quality of life.

Detailed description

no extensive description

Interventions

OTHERPhysical therapy aimed to move safely

Physical Therapy according to the Dutch guidelines for Physical Therapy in Parkinson's Disease solely focused on safety of movement. Duration program: 2 years Maximum number of sessions: 35 per year Duration sessions: 30 minutes

OTHERPhysical Therapy aimed to improve Physical Activity

Physical Therapy according to the Dutch guidelines for Physical Therapy in Parkinson's Disease combined with a coaching program aimed to promote the level of physical activity Duration program: 2 years Maximum number of sessions: 35 per year Duration of sessions: 30 minutes

Sponsors

Michael J. Fox Foundation for Parkinson's Research
CollaboratorOTHER
ZonMw: The Netherlands Organisation for Health Research and Development
CollaboratorOTHER
Radboud University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Idiopathic PD * Hoehn and Yahr stage I-III * Between 40 and 75 years old * Not meeting the norm for healthy physical activity: the latter being defined according to international standards as either five days a week 30 minutes of moderate-intensity physical activity, or 3 days a week 20 minutes of vigorous-intensity physical activity

Exclusion criteria

* Wheel chair bounded * Severe co-morbidity (e.g. orthopaedic disorders or chronic hart failure) * Severe cognitive decline, defined as Mini Mental State Examination \< 24

Design outcomes

Primary

MeasureTime frame
Level of Physical Activity based on the LAPAQ questionnaireAverage of 6, 12, 18 and 24 months

Secondary

MeasureTime frame
Level of Physical Activity based on an activity monitorcontinuous during 24 months
Physical Fitness (Six Minute Walk Test & Astrand bicycle test)12 and 24 months
Quality of Life (PDQ-39)6, 12, 18 and 24 months
Mood and Depression (HADS)6, 12, 18 and 24 months
Cognition (CANTAB)12 and 24 months
disease severity ( Nine Hole Peg test, UPDRS)12 and 24 months
One week diary of physical activityAverage of 6, 12, 18 and 24 months
Mobility (Timed up and go test)12 and 24 months
Fatigue (FSS)6, 12, 18 and 24 months
Medication (questionnaire)6, 12, 18 and 24 months
Medical Costs (questionnaire)6, 12, 18 and 24 months
Quality of Sleep (SCOPA-sleep)6, 12, 18 and 24 months
Safety(Falls)monthly

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026