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

January 27, 2012 updated by: dr Marten Munneke, PT, Radboud University Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

no extensive description

Study Type

Interventional

Enrollment (Actual)

700

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Delft, Netherlands
        • Reinier de Graaf Groep
      • Deventer, Netherlands
        • Deventer Ziekenhuis
      • Doetinchem, Netherlands
        • Slingeland Ziekenhuis
      • Geldrop, Netherlands
        • St. Anna Ziekenhuis
      • Gouda, Netherlands
        • Groene Hart ziekenhuis
      • Haarlem, Netherlands
        • Kennemer Gasthuis
      • Heerlen, Netherlands
        • Atrium medisch centrum
      • Hoorn, Netherlands
        • Westfriesgasthuis
      • Maastricht, Netherlands
        • Academisch Ziekenhuis Maastricht
      • Oss, Netherlands
        • Ziekenhuis Bernhoven
      • Roermond, Netherlands
        • Laurentius Ziekenhuis
      • Roosendaal, Netherlands
        • Franciscus Ziekenhuis
      • Rotterdam, Netherlands
        • Maasstad Ziekenhuis
      • Rotterdam, Netherlands
        • Sint Franciscus Gasthuis
      • Rotterdam, Netherlands
        • Erasmus Medisch Centrum
      • Schiedam, Netherlands
        • Vlietland Ziekenhuis
      • Sittard, Netherlands
        • Orbis Medisch Centrum
      • Zoetermeer, Netherlands
        • 't Lange Land Ziekenhuis
    • Postbus 10016
      • Hilversum, Postbus 10016, Netherlands, 1201 DA
        • Tergooiziekenhuizen
    • Postbus 1101
      • Den Bosch, Postbus 1101, Netherlands, 5200 BD
        • Jeroen Bosch Ziekenhuis
    • Postbus 1350
      • Eindhoven, Postbus 1350, Netherlands, 5602 ZA
        • Catharina Ziekenhuis
    • Postbus 1926
      • Venlo, Postbus 1926, Netherlands, 5900 BX
        • Vie Curie Medisch Centrum
    • Postbus 40551
      • Den Haag, Postbus 40551, Netherlands, 2504 LN
        • Hagaziekhuis
    • Postbus 432
      • Den Haag, Postbus 432, Netherlands, 2501 CK
        • Medisch Centrum Haaglanden
    • Postbus 50
      • Alkmaar, Postbus 50, Netherlands, 1800 AM
        • Medisch Centrum Alkmaar
    • Postbus 5500
      • Sittard, Postbus 5500, Netherlands, 6130 MB
        • Maaslandziekenhuis
    • Postbus 900
      • Blaricum, Postbus 900, Netherlands, 1250 CA
        • Tergooiziekenhuizen
    • Postbus 9014
      • Apeldoorn, Postbus 9014, Netherlands, 7300 DS
        • Gelreziekenhuizen
    • Postbus 90157
      • Breda, Postbus 90157, Netherlands, 4800 RL
        • Amphia Ziekenhuis
    • Postbus 9020
      • Zutphen, Postbus 9020, Netherlands, 7200 GZ
        • De Gelreziekenhuizen
    • Postbus 9025
      • Ede, Postbus 9025, Netherlands, 6710 HN
        • Ziekenhuis Gelderse Vallei
    • Postbus 98
      • Helmond, Postbus 98, Netherlands, 5700 AB
        • Elkerliek Ziekenhuis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Level of Physical Activity based on the LAPAQ questionnaire
Time Frame: Average of 6, 12, 18 and 24 months
Average of 6, 12, 18 and 24 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

September 5, 2008

First Submitted That Met QC Criteria

September 5, 2008

First Posted (Estimate)

September 8, 2008

Study Record Updates

Last Update Posted (Estimate)

January 31, 2012

Last Update Submitted That Met QC Criteria

January 27, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 50-50310-98-034

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Parkinson's Disease

Clinical Trials on Physical Therapy aimed to improve Physical Activity

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo, DR of

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe