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

September 5, 2008
January 27, 2012
September 2008
December 2011   (final data collection date for primary outcome measure)
Level of Physical Activity based on the LAPAQ questionnaire [ Time Frame: Average of 6, 12, 18 and 24 months ] [ Designated as safety issue: No ]
Level of Physical Activity based on the LAPAQ questionnaire and a one week diary of physical activity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00748488 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Level of Physical Activity based on the LAPAQ questionnaire and a one week diary of physical activity [ Time Frame: 12 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 (Astrand bicycle test) [ Time Frame: 0, 12 and 24 months ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: 6, 12 and 24 months ] [ Designated as safety issue: No ]
  • Mood and Depression (HADS) [ Time Frame: 6, 12 and 24 months ] [ Designated as safety issue: No ]
  • Cognition (CANTAB) [ Time Frame: 6, 12 and 24 months ] [ Designated as safety issue: No ]
  • disease severity ( Nine Hole Peg test, UPDRS) [ Time Frame: 0,12,24 months ] [ Designated as safety issue: No ]
  • Safety(Falls) [ Time Frame: monthly ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Effectiveness of an Active Lifestyle Promotion Program for Patients With Parkinson's Disease
The ParkFit Study; 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.

no extensive description

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Parkinson's Disease
  • 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.
  • 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.
  • Experimental: A
    Physical Therapy aimed to promote the level of physical activity
    Intervention: Other: Physical Therapy aimed to improve Physical Activity
  • Active Comparator: B
    Physical Therapy aimed to move safely
    Intervention: Other: Physical therapy aimed to move safely

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
700
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Both
40 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00748488
50-50310-98-034
Yes
dr Marten Munneke, PT, Radboud University
Radboud University
  • Michael J. Fox Foundation for Parkinson's Research
  • ZonMw: The Netherlands Organisation for Health Research and Development
Principal Investigator: Marten Munneke, Dr. UMC st Radboud
Radboud University
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP