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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00748488
First Posted: September 8, 2008
Last Update Posted: January 31, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Michael J. Fox Foundation for Parkinson's Research
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
dr Marten Munneke, PT, Radboud University
  Purpose

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.


Condition Intervention Phase
Parkinson's Disease Other: Physical therapy aimed to move safely Other: Physical Therapy aimed to improve Physical Activity Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The ParkFit Study; Effectiveness of an Active Lifestyle Promotion Program for Patients With Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by dr Marten Munneke, PT, Radboud University:

Primary Outcome Measures:
  • Level of Physical Activity based on the LAPAQ questionnaire [ Time Frame: Average of 6, 12, 18 and 24 months ]

Secondary Outcome Measures:
  • One week diary of physical activity [ Time Frame: Average of 6, 12, 18 and 24 months ]
  • Level of Physical Activity based on an activity monitor [ Time Frame: continuous during 24 months ]
  • Physical Fitness (Six Minute Walk Test & Astrand bicycle test) [ Time Frame: 12 and 24 months ]
  • Quality of Life (PDQ-39) [ Time Frame: 6, 12, 18 and 24 months ]
  • Mood and Depression (HADS) [ Time Frame: 6, 12, 18 and 24 months ]
  • Cognition (CANTAB) [ Time Frame: 12 and 24 months ]
  • disease severity ( Nine Hole Peg test, UPDRS) [ Time Frame: 12 and 24 months ]
  • Safety(Falls) [ Time Frame: monthly ]
  • Mobility (Timed up and go test) [ Time Frame: 12 and 24 months ]
  • Fatigue (FSS) [ Time Frame: 6, 12, 18 and 24 months ]
  • Medication (questionnaire) [ Time Frame: 6, 12, 18 and 24 months ]
  • Medical Costs (questionnaire) [ Time Frame: 6, 12, 18 and 24 months ]
  • Quality of Sleep (SCOPA-sleep) [ Time Frame: 6, 12, 18 and 24 months ]

Enrollment: 700
Study Start Date: September 2008
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Physical Therapy aimed to promote the level of physical activity
Other: Physical 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
Other Name: n.a.
Active Comparator: B
Physical Therapy aimed to move safely
Other: Physical 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

Other Name: n.a.

Detailed Description:
no extensive description
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00748488


Locations
Netherlands
Tergooiziekenhuizen
Hilversum, Postbus 10016, Netherlands, 1201 DA
Jeroen Bosch Ziekenhuis
Den Bosch, Postbus 1101, Netherlands, 5200 BD
Catharina ziekenhuis
Eindhoven, Postbus 1350, Netherlands, 5602 ZA
Vie Curie Medisch Centrum
Venlo, Postbus 1926, Netherlands, 5900 BX
Hagaziekhuis
Den Haag, Postbus 40551, Netherlands, 2504 LN
Medisch Centrum Haaglanden
Den Haag, Postbus 432, Netherlands, 2501 CK
Medisch Centrum alkmaar
Alkmaar, Postbus 50, Netherlands, 1800 AM
Maaslandziekenhuis
Sittard, Postbus 5500, Netherlands, 6130 MB
Tergooiziekenhuizen
Blaricum, Postbus 900, Netherlands, 1250 CA
Gelreziekenhuizen
Apeldoorn, Postbus 9014, Netherlands, 7300 DS
Amphia Ziekenhuis
Breda, Postbus 90157, Netherlands, 4800 RL
De Gelreziekenhuizen
Zutphen, Postbus 9020, Netherlands, 7200 GZ
Ziekenhuis Gelderse Vallei
Ede, Postbus 9025, Netherlands, 6710 HN
Elkerliek ziekenhuis
Helmond, Postbus 98, Netherlands, 5700 AB
Reinier de Graaf Groep
Delft, Netherlands
Deventer Ziekenhuis
Deventer, Netherlands
Slingeland Ziekenhuis
Doetinchem, Netherlands
St. Anna Ziekenhuis
Geldrop, Netherlands
Groene Hart Ziekenhuis
Gouda, Netherlands
Kennemer Gasthuis
Haarlem, Netherlands
Atrium Medisch Centrum
Heerlen, Netherlands
Westfriesgasthuis
Hoorn, Netherlands
Academisch Ziekenhuis Maastricht
Maastricht, Netherlands
Ziekenhuis Bernhoven
Oss, Netherlands
Laurentius Ziekenhuis
Roermond, Netherlands
Franciscus Ziekenhuis
Roosendaal, Netherlands
Erasmus Medisch Centrum
Rotterdam, Netherlands
Maasstad Ziekenhuis
Rotterdam, Netherlands
Sint Franciscus Gasthuis
Rotterdam, Netherlands
Vlietland Ziekenhuis
Schiedam, Netherlands
Orbis Medisch Centrum
Sittard, Netherlands
't Lange Land Ziekenhuis
Zoetermeer, Netherlands
Sponsors and Collaborators
Radboud University
Michael J. Fox Foundation for Parkinson's Research
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
Principal Investigator: Marten Munneke, Dr. UMC st Radboud
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: dr Marten Munneke, PT, Dr, Radboud University
ClinicalTrials.gov Identifier: NCT00748488     History of Changes
Other Study ID Numbers: 50-50310-98-034
First Submitted: September 5, 2008
First Posted: September 8, 2008
Last Update Posted: January 31, 2012
Last Verified: January 2012

Keywords provided by dr Marten Munneke, PT, Radboud University:
Parkinson
Physical Therapy
Physical Activity

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases