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

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
Physical therapy aimed to move safely
Physical Therapy aimed to improve Physical Activity
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson, Physical Therapy, Physical Activity

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tergooiziekenhuizen
  • Jeroen Bosch Ziekenhuis
  • Catharina ziekenhuis
  • Vie Curie Medisch Centrum
  • Hagaziekhuis
  • Medisch Centrum Haaglanden
  • Medisch Centrum alkmaar
  • Maaslandziekenhuis
  • Tergooiziekenhuizen
  • Gelreziekenhuizen
  • Amphia Ziekenhuis
  • De Gelreziekenhuizen
  • Ziekenhuis Gelderse Vallei
  • Elkerliek ziekenhuis
  • Reinier de Graaf Groep
  • Deventer Ziekenhuis
  • Slingeland Ziekenhuis
  • St. Anna Ziekenhuis
  • Groene Hart Ziekenhuis
  • Kennemer Gasthuis
  • Atrium Medisch Centrum
  • Westfriesgasthuis
  • Academisch Ziekenhuis Maastricht
  • Ziekenhuis Bernhoven
  • Laurentius Ziekenhuis
  • Franciscus Ziekenhuis
  • Erasmus Medisch Centrum
  • Maasstad Ziekenhuis
  • Sint Franciscus Gasthuis
  • Vlietland Ziekenhuis
  • Orbis Medisch Centrum
  • 't Lange Land Ziekenhuis

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A

B

Arm Description

Physical Therapy aimed to promote the level of physical activity

Physical Therapy aimed to move safely

Outcomes

Primary Outcome Measures

Level of Physical Activity based on the LAPAQ questionnaire

Secondary Outcome Measures

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

Full Information

First Posted
September 5, 2008
Last Updated
January 27, 2012
Sponsor
Radboud University Medical Center
Collaborators
Michael J. Fox Foundation for Parkinson's Research, ZonMw: The Netherlands Organisation for Health Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT00748488
Brief Title
Effectiveness of an Active Lifestyle Promotion Program for Patients With Parkinson's Disease
Acronym
ParkFit
Official Title
The ParkFit Study; Effectiveness of an Active Lifestyle Promotion Program for Patients With Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Radboud University Medical Center
Collaborators
Michael J. Fox Foundation for Parkinson's Research, ZonMw: The Netherlands Organisation for Health Research and Development

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
no extensive description

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson, Physical Therapy, Physical Activity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
700 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Physical Therapy aimed to promote the level of physical activity
Arm Title
B
Arm Type
Active Comparator
Arm Description
Physical Therapy aimed to move safely
Intervention Type
Other
Intervention Name(s)
Physical therapy aimed to move safely
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Physical Therapy aimed to improve Physical Activity
Intervention Description
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 Outcome Measure Information:
Title
Level of Physical Activity based on the LAPAQ questionnaire
Time Frame
Average of 6, 12, 18 and 24 months
Secondary Outcome Measure Information:
Title
One week diary of physical activity
Time Frame
Average of 6, 12, 18 and 24 months
Title
Level of Physical Activity based on an activity monitor
Time Frame
continuous during 24 months
Title
Physical Fitness (Six Minute Walk Test & Astrand bicycle test)
Time Frame
12 and 24 months
Title
Quality of Life (PDQ-39)
Time Frame
6, 12, 18 and 24 months
Title
Mood and Depression (HADS)
Time Frame
6, 12, 18 and 24 months
Title
Cognition (CANTAB)
Time Frame
12 and 24 months
Title
disease severity ( Nine Hole Peg test, UPDRS)
Time Frame
12 and 24 months
Title
Safety(Falls)
Time Frame
monthly
Title
Mobility (Timed up and go test)
Time Frame
12 and 24 months
Title
Fatigue (FSS)
Time Frame
6, 12, 18 and 24 months
Title
Medication (questionnaire)
Time Frame
6, 12, 18 and 24 months
Title
Medical Costs (questionnaire)
Time Frame
6, 12, 18 and 24 months
Title
Quality of Sleep (SCOPA-sleep)
Time Frame
6, 12, 18 and 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marten Munneke, Dr.
Organizational Affiliation
UMC st Radboud
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tergooiziekenhuizen
City
Hilversum
State/Province
Postbus 10016
ZIP/Postal Code
1201 DA
Country
Netherlands
Facility Name
Jeroen Bosch Ziekenhuis
City
Den Bosch
State/Province
Postbus 1101
ZIP/Postal Code
5200 BD
Country
Netherlands
Facility Name
Catharina ziekenhuis
City
Eindhoven
State/Province
Postbus 1350
ZIP/Postal Code
5602 ZA
Country
Netherlands
Facility Name
Vie Curie Medisch Centrum
City
Venlo
State/Province
Postbus 1926
ZIP/Postal Code
5900 BX
Country
Netherlands
Facility Name
Hagaziekhuis
City
Den Haag
State/Province
Postbus 40551
ZIP/Postal Code
2504 LN
Country
Netherlands
Facility Name
Medisch Centrum Haaglanden
City
Den Haag
State/Province
Postbus 432
ZIP/Postal Code
2501 CK
Country
Netherlands
Facility Name
Medisch Centrum alkmaar
City
Alkmaar
State/Province
Postbus 50
ZIP/Postal Code
1800 AM
Country
Netherlands
Facility Name
Maaslandziekenhuis
City
Sittard
State/Province
Postbus 5500
ZIP/Postal Code
6130 MB
Country
Netherlands
Facility Name
Tergooiziekenhuizen
City
Blaricum
State/Province
Postbus 900
ZIP/Postal Code
1250 CA
Country
Netherlands
Facility Name
Gelreziekenhuizen
City
Apeldoorn
State/Province
Postbus 9014
ZIP/Postal Code
7300 DS
Country
Netherlands
Facility Name
Amphia Ziekenhuis
City
Breda
State/Province
Postbus 90157
ZIP/Postal Code
4800 RL
Country
Netherlands
Facility Name
De Gelreziekenhuizen
City
Zutphen
State/Province
Postbus 9020
ZIP/Postal Code
7200 GZ
Country
Netherlands
Facility Name
Ziekenhuis Gelderse Vallei
City
Ede
State/Province
Postbus 9025
ZIP/Postal Code
6710 HN
Country
Netherlands
Facility Name
Elkerliek ziekenhuis
City
Helmond
State/Province
Postbus 98
ZIP/Postal Code
5700 AB
Country
Netherlands
Facility Name
Reinier de Graaf Groep
City
Delft
Country
Netherlands
Facility Name
Deventer Ziekenhuis
City
Deventer
Country
Netherlands
Facility Name
Slingeland Ziekenhuis
City
Doetinchem
Country
Netherlands
Facility Name
St. Anna Ziekenhuis
City
Geldrop
Country
Netherlands
Facility Name
Groene Hart Ziekenhuis
City
Gouda
Country
Netherlands
Facility Name
Kennemer Gasthuis
City
Haarlem
Country
Netherlands
Facility Name
Atrium Medisch Centrum
City
Heerlen
Country
Netherlands
Facility Name
Westfriesgasthuis
City
Hoorn
Country
Netherlands
Facility Name
Academisch Ziekenhuis Maastricht
City
Maastricht
Country
Netherlands
Facility Name
Ziekenhuis Bernhoven
City
Oss
Country
Netherlands
Facility Name
Laurentius Ziekenhuis
City
Roermond
Country
Netherlands
Facility Name
Franciscus Ziekenhuis
City
Roosendaal
Country
Netherlands
Facility Name
Erasmus Medisch Centrum
City
Rotterdam
Country
Netherlands
Facility Name
Maasstad Ziekenhuis
City
Rotterdam
Country
Netherlands
Facility Name
Sint Franciscus Gasthuis
City
Rotterdam
Country
Netherlands
Facility Name
Vlietland Ziekenhuis
City
Schiedam
Country
Netherlands
Facility Name
Orbis Medisch Centrum
City
Sittard
Country
Netherlands
Facility Name
't Lange Land Ziekenhuis
City
Zoetermeer
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
23457213
Citation
van Nimwegen M, Speelman AD, Overeem S, van de Warrenburg BP, Smulders K, Dontje ML, Borm GF, Backx FJ, Bloem BR, Munneke M; ParkFit Study Group. Promotion of physical activity and fitness in sedentary patients with Parkinson's disease: randomised controlled trial. BMJ. 2013 Mar 1;346:f576. doi: 10.1136/bmj.f576.
Results Reference
derived
PubMed Identifier
20723221
Citation
van Nimwegen M, Speelman AD, Smulders K, Overeem S, Borm GF, Backx FJ, Bloem BR, Munneke M; ParkFit Study Group. Design and baseline characteristics of the ParkFit study, a randomized controlled trial evaluating the effectiveness of a multifaceted behavioral program to increase physical activity in Parkinson patients. BMC Neurol. 2010 Aug 19;10:70. doi: 10.1186/1471-2377-10-70.
Results Reference
derived

Learn more about this trial

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

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