Clinical trial NCT00748488: Effectiveness of an Active Lifestyle Promotion Program for Patients With Parkinson's Disease
Official title: The ParkFit Study; Effectiveness of an Active Lifestyle Promotion Program for Patients With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parkinson's Disease
Keywords: Parkinson
Physical Therapy
Physical Activity
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Michael J. Fox Foundation for Parkinson's Research
name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2008-09-08
Enrollment: 700
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Level of Physical Activity based on the LAPAQ questionnaire
timeFrame: Average of 6, 12, 18 and 24 months
Secondary outcomes:
measure: One week diary of physical activity
timeFrame: Average of 6, 12, 18 and 24 months
measure: Level of Physical Activity based on an activity monitor
timeFrame: continuous during 24 months
measure: Physical Fitness (Six Minute Walk Test & Astrand bicycle test)
timeFrame: 12 and 24 months
measure: Quality of Life (PDQ-39)
timeFrame: 6, 12, 18 and 24 months
measure: Mood and Depression (HADS)
timeFrame: 6, 12, 18 and 24 months
measure: Cognition (CANTAB)
timeFrame: 12 and 24 months
measure: disease severity ( Nine Hole Peg test, UPDRS)
timeFrame: 12 and 24 months
measure: Safety(Falls)
timeFrame: monthly
measure: Mobility (Timed up and go test)
timeFrame: 12 and 24 months
measure: Fatigue (FSS)
timeFrame: 6, 12, 18 and 24 months
measure: Medication (questionnaire)
timeFrame: 6, 12, 18 and 24 months
measure: Medical Costs (questionnaire)
timeFrame: 6, 12, 18 and 24 months
measure: Quality of Sleep (SCOPA-sleep)
timeFrame: 6, 12, 18 and 24 months
Other outcomes:
Locations:
city: Hilversum
country: Netherlands
facility: Tergooiziekenhuizen
state: Postbus 10016
city: Den Bosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis
state: Postbus 1101
city: Eindhoven
country: Netherlands
facility: Catharina ziekenhuis
state: Postbus 1350
city: Venlo
country: Netherlands
facility: Vie Curie Medisch Centrum
state: Postbus 1926
city: Den Haag
country: Netherlands
facility: Hagaziekhuis
state: Postbus 40551
city: Den Haag
country: Netherlands
facility: Medisch Centrum Haaglanden
state: Postbus 432
city: Alkmaar
country: Netherlands
facility: Medisch Centrum alkmaar
state: Postbus 50
city: Sittard
country: Netherlands
facility: Maaslandziekenhuis
state: Postbus 5500
city: Blaricum
country: Netherlands
facility: Tergooiziekenhuizen
state: Postbus 900
city: Apeldoorn
country: Netherlands
facility: Gelreziekenhuizen
state: Postbus 9014
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
state: Postbus 90157
city: Zutphen
country: Netherlands
facility: De Gelreziekenhuizen
state: Postbus 9020
city: Ede
country: Netherlands
facility: Ziekenhuis Gelderse Vallei
state: Postbus 9025
city: Helmond
country: Netherlands
facility: Elkerliek ziekenhuis
state: Postbus 98
city: Delft
country: Netherlands
facility: Reinier de Graaf Groep
city: Deventer
country: Netherlands
facility: Deventer Ziekenhuis
city: Doetinchem
country: Netherlands
facility: Slingeland Ziekenhuis
city: Geldrop
country: Netherlands
facility: St. Anna Ziekenhuis
city: Gouda
country: Netherlands
facility: Groene Hart Ziekenhuis
city: Haarlem
country: Netherlands
facility: Kennemer Gasthuis
city: Heerlen
country: Netherlands
facility: Atrium Medisch Centrum
city: Hoorn
country: Netherlands
facility: Westfriesgasthuis
city: Maastricht
country: Netherlands
facility: Academisch Ziekenhuis Maastricht
city: Oss
country: Netherlands
facility: Ziekenhuis Bernhoven
city: Roermond
country: Netherlands
facility: Laurentius Ziekenhuis
city: Roosendaal
country: Netherlands
facility: Franciscus Ziekenhuis
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum
city: Rotterdam
country: Netherlands
facility: Maasstad Ziekenhuis
city: Rotterdam
country: Netherlands
facility: Sint Franciscus Gasthuis
city: Schiedam
country: Netherlands
facility: Vlietland Ziekenhuis
city: Sittard
country: Netherlands
facility: Orbis Medisch Centrum
city: Zoetermeer
country: Netherlands
facility: 't Lange Land Ziekenhuis
Study officials:
affiliation: UMC st Radboud
name: Marten Munneke, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.