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

Phase 3

Completed

• Conditions: Parkinson's Disease
• Interventions: Other: Physical Therapy aimed to improve Physical Activity; Other: Physical therapy aimed to move safely

• Registration Number: NCT00748488
• Lead Sponsor: Radboud University Medical Center

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

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-09-05
• Study First Submitted QC: 2008-09-05
• Study First Posted: 2008-09-08
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-27
• Last Update Posted: 2012-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 700

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Physical Therapy aimed to improve Physical Activity	Physical Therapy aimed to promote the level of physical activity
B	Physical therapy aimed to move safely	Physical Therapy aimed to move safely

Primary Outcome Measures

Name	Time	Method
Level of Physical Activity based on the LAPAQ questionnaire	Average of 6, 12, 18 and 24 months

Secondary Outcome Measures

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

Trial Locations

Locations (31)

Tergooiziekenhuizen; 🇳🇱 Blaricum, Postbus 900, Netherlands

Vie Curie Medisch Centrum; 🇳🇱 Venlo, Postbus 1926, Netherlands

Medisch Centrum alkmaar; 🇳🇱 Alkmaar, Postbus 50, Netherlands

Maaslandziekenhuis; 🇳🇱 Sittard, Postbus 5500, Netherlands

Jeroen Bosch Ziekenhuis; 🇳🇱 Den Bosch, Postbus 1101, Netherlands

Catharina ziekenhuis; 🇳🇱 Eindhoven, Postbus 1350, Netherlands

Hagaziekhuis; 🇳🇱 Den Haag, Postbus 40551, Netherlands

Medisch Centrum Haaglanden; 🇳🇱 Den Haag, Postbus 432, Netherlands

Gelreziekenhuizen; 🇳🇱 Apeldoorn, Postbus 9014, Netherlands

Amphia Ziekenhuis; 🇳🇱 Breda, Postbus 90157, Netherlands

Reinier de Graaf Groep; 🇳🇱 Delft, Netherlands

Deventer Ziekenhuis; 🇳🇱 Deventer, Netherlands

Slingeland Ziekenhuis; 🇳🇱 Doetinchem, Netherlands

Groene Hart Ziekenhuis; 🇳🇱 Gouda, Netherlands

De Gelreziekenhuizen; 🇳🇱 Zutphen, Postbus 9020, Netherlands

Elkerliek ziekenhuis; 🇳🇱 Helmond, Postbus 98, Netherlands

Ziekenhuis Gelderse Vallei; 🇳🇱 Ede, Postbus 9025, Netherlands

St. Anna Ziekenhuis; 🇳🇱 Geldrop, Netherlands

Kennemer Gasthuis; 🇳🇱 Haarlem, Netherlands

Academisch Ziekenhuis Maastricht; 🇳🇱 Maastricht, Netherlands

Franciscus Ziekenhuis; 🇳🇱 Roosendaal, Netherlands

Erasmus Medisch Centrum; 🇳🇱 Rotterdam, Netherlands

Sint Franciscus Gasthuis; 🇳🇱 Rotterdam, Netherlands

Vlietland Ziekenhuis; 🇳🇱 Schiedam, Netherlands

Maasstad Ziekenhuis; 🇳🇱 Rotterdam, Netherlands

Atrium Medisch Centrum; 🇳🇱 Heerlen, Netherlands

Westfriesgasthuis; 🇳🇱 Hoorn, Netherlands

Ziekenhuis Bernhoven; 🇳🇱 Oss, Netherlands

Laurentius Ziekenhuis; 🇳🇱 Roermond, Netherlands

Orbis Medisch Centrum; 🇳🇱 Sittard, Netherlands

't Lange Land Ziekenhuis; 🇳🇱 Zoetermeer, Netherlands