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

NCT ID: NCT00748488

Last Updated: 2012-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

700 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2011-12-31

Brief Summary

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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

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no extensive description

Conditions

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Parkinson's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A

Physical Therapy aimed to promote the level of physical activity

Group Type EXPERIMENTAL

Physical Therapy aimed to improve Physical Activity

Intervention Type OTHER

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

B

Physical Therapy aimed to move safely

Group Type ACTIVE_COMPARATOR

Physical therapy aimed to move safely

Intervention Type OTHER

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

Interventions

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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

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Michael J. Fox Foundation for Parkinson's Research

OTHER

Sponsor Role collaborator

ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

Sponsor Role collaborator

Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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dr Marten Munneke, PT

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marten Munneke, Dr.

Role: PRINCIPAL_INVESTIGATOR

UMC st Radboud

Locations

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Tergooiziekenhuizen

Hilversum, Postbus 10016, Netherlands

Site Status

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, Postbus 1101, Netherlands

Site Status

Catharina ziekenhuis

Eindhoven, Postbus 1350, Netherlands

Site Status

Vie Curie Medisch Centrum

Venlo, Postbus 1926, Netherlands

Site Status

Hagaziekhuis

The Hague, Postbus 40551, Netherlands

Site Status

Medisch Centrum Haaglanden

The Hague, Postbus 432, Netherlands

Site Status

Medisch Centrum alkmaar

Alkmaar, Postbus 50, Netherlands

Site Status

Maaslandziekenhuis

Sittard, Postbus 5500, Netherlands

Site Status

Tergooiziekenhuizen

Blaricum, Postbus 900, Netherlands

Site Status

Gelreziekenhuizen

Apeldoorn, Postbus 9014, Netherlands

Site Status

Amphia Ziekenhuis

Breda, Postbus 90157, Netherlands

Site Status

De Gelreziekenhuizen

Zutphen, Postbus 9020, Netherlands

Site Status

Ziekenhuis Gelderse Vallei

Ede, Postbus 9025, Netherlands

Site Status

Elkerliek ziekenhuis

Helmond, Postbus 98, Netherlands

Site Status

Reinier de Graaf Groep

Delft, , Netherlands

Site Status

Deventer Ziekenhuis

Deventer, , Netherlands

Site Status

Slingeland Ziekenhuis

Doetinchem, , Netherlands

Site Status

St. Anna Ziekenhuis

Geldrop, , Netherlands

Site Status

Groene Hart Ziekenhuis

Gouda, , Netherlands

Site Status

Kennemer Gasthuis

Haarlem, , Netherlands

Site Status

Atrium Medisch Centrum

Heerlen, , Netherlands

Site Status

Westfriesgasthuis

Hoorn, , Netherlands

Site Status

Academisch Ziekenhuis Maastricht

Maastricht, , Netherlands

Site Status

Ziekenhuis Bernhoven

Oss, , Netherlands

Site Status

Laurentius Ziekenhuis

Roermond, , Netherlands

Site Status

Franciscus Ziekenhuis

Roosendaal, , Netherlands

Site Status

Erasmus Medisch Centrum

Rotterdam, , Netherlands

Site Status

Maasstad Ziekenhuis

Rotterdam, , Netherlands

Site Status

Sint Franciscus Gasthuis

Rotterdam, , Netherlands

Site Status

Vlietland Ziekenhuis

Schiedam, , Netherlands

Site Status

Orbis Medisch Centrum

Sittard, , Netherlands

Site Status

't Lange Land Ziekenhuis

Zoetermeer, , Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type DERIVED
PMID: 23457213 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20723221 (View on PubMed)

Other Identifiers

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50-50310-98-034

Identifier Type: -

Identifier Source: org_study_id

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