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

Radboud University Medical Center

Status and phase: Completed; Phase 3

Conditions: Parkinson's Disease

Treatments: Other: Physical Therapy aimed to improve Physical Activity; Other: Physical therapy aimed to move safely

Study type: Interventional

Funder types: Other

Identifiers

NCT00748488

50-50310-98-034

Details and patient eligibility

About

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.

Full description

no extensive description

Enrollment: 700 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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700 participants in 2 patient groups

A

Experimental group

Description:

Physical Therapy aimed to promote the level of physical activity

Treatment:

Other: Physical Therapy aimed to improve Physical Activity

B

Active Comparator group

Description:

Physical Therapy aimed to move safely

Treatment:

Other: Physical therapy aimed to move safely