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

This study has been completed.
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT00748488
First received: September 5, 2008
Last updated: January 27, 2012
Last verified: January 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Level of Physical Activity based on the LAPAQ questionnaire [ Time Frame: Average of 6, 12, 18 and 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • One week diary of physical activity [ Time Frame: Average of 6, 12, 18 and 24 months ] [ Designated as safety issue: No ]
  • Level of Physical Activity based on an activity monitor [ Time Frame: continuous during 24 months ] [ Designated as safety issue: No ]
  • Physical Fitness (Six Minute Walk Test & Astrand bicycle test) [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
  • Quality of Life (PDQ-39) [ Time Frame: 6, 12, 18 and 24 months ] [ Designated as safety issue: No ]
  • Mood and Depression (HADS) [ Time Frame: 6, 12, 18 and 24 months ] [ Designated as safety issue: No ]
  • Cognition (CANTAB) [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
  • disease severity ( Nine Hole Peg test, UPDRS) [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
  • Safety(Falls) [ Time Frame: monthly ] [ Designated as safety issue: Yes ]
  • Mobility (Timed up and go test) [ Time Frame: 12 and 24 months ] [ Designated as safety issue: No ]
  • Fatigue (FSS) [ Time Frame: 6, 12, 18 and 24 months ] [ Designated as safety issue: No ]
  • Medication (questionnaire) [ Time Frame: 6, 12, 18 and 24 months ] [ Designated as safety issue: No ]
  • Medical Costs (questionnaire) [ Time Frame: 6, 12, 18 and 24 months ] [ Designated as safety issue: No ]
  • Quality of Sleep (SCOPA-sleep) [ Time Frame: 6, 12, 18 and 24 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Sint Franciscus Gasthuis
Rotterdam, Netherlands
Maasstad Ziekenhuis
Rotterdam, Netherlands
Erasmus Medisch Centrum
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

No publications provided by Radboud University

Additional 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
Study First Received: September 5, 2008
Last Updated: January 27, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by 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

ClinicalTrials.gov processed this record on May 22, 2013