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OpenTrials
Completed

NCT Number: NCT00748488

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

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.

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Key information

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Tergooiziekenhuizen, Hilversum, Postbus 10016, Netherlands

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About this study

no extensive description

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical therapy aimed to move safely

Other

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

Physical Therapy aimed to improve Physical Activity

Other

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

Primary outcomes

  1. Level of Physical Activity based on the LAPAQ questionnaire

    Time frame: Average of 6, 12, 18 and 24 months

Secondary outcomes

  1. One week diary of physical activity

    Time frame: Average of 6, 12, 18 and 24 months

  2. Level of Physical Activity based on an activity monitor

    Time frame: continuous during 24 months

  3. Physical Fitness (Six Minute Walk Test & Astrand bicycle test)

    Time frame: 12 and 24 months

  4. Quality of Life (PDQ-39)

    Time frame: 6, 12, 18 and 24 months

  5. Mood and Depression (HADS)

    Time frame: 6, 12, 18 and 24 months

  6. Cognition (CANTAB)

    Time frame: 12 and 24 months

  7. disease severity ( Nine Hole Peg test, UPDRS)

    Time frame: 12 and 24 months

  8. Safety(Falls)

    Time frame: monthly

  9. Mobility (Timed up and go test)

    Time frame: 12 and 24 months

  10. Fatigue (FSS)

    Time frame: 6, 12, 18 and 24 months

  11. Medication (questionnaire)

    Time frame: 6, 12, 18 and 24 months

  12. Medical Costs (questionnaire)

    Time frame: 6, 12, 18 and 24 months

  13. Quality of Sleep (SCOPA-sleep)

    Time frame: 6, 12, 18 and 24 months

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • Michael J. Fox Foundation for Parkinson's Research
  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Official study title

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

Acronym: ParkFit

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Sep 8, 2008
Registry last updated
Jan 31, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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