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

Study Overview
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Brief Summary
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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
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no extensive description

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

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Other: Physical therapy aimed to move safely
* Other: Physical Therapy aimed to improve Physical Activity


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Physical Therapy aimed to promote the level of physical activity | Other: Physical Therapy aimed to improve Physical Activity<br>* 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<br>|
| Active Comparator: B<br>Physical Therapy aimed to move safely | Other: Physical therapy aimed to move safely<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of Physical Activity based on the LAPAQ questionnaire |  | Average of 6, 12, 18 and 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| One week diary of physical activity |  | Average of 6, 12, 18 and 24 months | 
| Level of Physical Activity based on an activity monitor |  | continuous 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 | 
| Safety(Falls) |  | monthly | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson, Physical Therapy, Physical Activity