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

Parkinson's Disease Clinical Trial

— ParkFit  

Official title:

The ParkFit Study; Effectiveness of an Active Lifestyle Promotion Program for Patients With Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00748488
• Other study ID #: 50-50310-98-034
• Status: Completed
• Phase: Phase 3
• First received: September 5, 2008
• Last updated: January 27, 2012
• Start date: September 2008
• Est. completion date: December 2011

Study information

• Verified date: January 2012
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Description:

no extensive description

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

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
• 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

Locations

Country	Name	City	State
Netherlands	Medisch Centrum alkmaar	Alkmaar	Postbus 50
Netherlands	Gelreziekenhuizen	Apeldoorn	Postbus 9014
Netherlands	Tergooiziekenhuizen	Blaricum	Postbus 900
Netherlands	Amphia Ziekenhuis	Breda	Postbus 90157
Netherlands	Reinier de Graaf Groep	Delft
Netherlands	Jeroen Bosch Ziekenhuis	Den Bosch	Postbus 1101
Netherlands	Hagaziekhuis	Den Haag	Postbus 40551
Netherlands	Medisch Centrum Haaglanden	Den Haag	Postbus 432
Netherlands	Deventer Ziekenhuis	Deventer
Netherlands	Slingeland Ziekenhuis	Doetinchem
Netherlands	Ziekenhuis Gelderse Vallei	Ede	Postbus 9025
Netherlands	Catharina ziekenhuis	Eindhoven	Postbus 1350
Netherlands	St. Anna Ziekenhuis	Geldrop
Netherlands	Groene Hart Ziekenhuis	Gouda
Netherlands	Kennemer Gasthuis	Haarlem
Netherlands	Atrium Medisch Centrum	Heerlen
Netherlands	Elkerliek ziekenhuis	Helmond	Postbus 98
Netherlands	Tergooiziekenhuizen	Hilversum	Postbus 10016
Netherlands	Westfriesgasthuis	Hoorn
Netherlands	Academisch Ziekenhuis Maastricht	Maastricht
Netherlands	Ziekenhuis Bernhoven	Oss
Netherlands	Laurentius Ziekenhuis	Roermond
Netherlands	Franciscus Ziekenhuis	Roosendaal
Netherlands	Erasmus Medisch Centrum	Rotterdam
Netherlands	Maasstad Ziekenhuis	Rotterdam
Netherlands	Sint Franciscus Gasthuis	Rotterdam
Netherlands	Vlietland Ziekenhuis	Schiedam
Netherlands	Maaslandziekenhuis	Sittard	Postbus 5500
Netherlands	Orbis Medisch Centrum	Sittard
Netherlands	Vie Curie Medisch Centrum	Venlo	Postbus 1926
Netherlands	't Lange Land Ziekenhuis	Zoetermeer
Netherlands	De Gelreziekenhuizen	Zutphen	Postbus 9020

Sponsors (3)

Lead Sponsor	Collaborator
Radboud University	Michael J. Fox Foundation for Parkinson's Research, ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

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