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

NCT00748488 | Completed Phase 3 DMC

• 1 other identifier: 50-50310-98-034
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 32

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.

Conditions

Parkinson's Disease

Keywords

Parkinson; Physical Therapy; Physical Activity

Outcome Measures

Primary Outcomes (1)

• Level of Physical Activity based on the LAPAQ questionnaire

  Average of 6, 12, 18 and 24 months

Secondary Outcomes (13)

• One week diary of physical activity

  Average of 6, 12, 18 and 24 months

• Level of Physical Activity based on an activity monitor

  continuous during 24 months

• Physical Fitness (Six Minute Walk Test & Astrand bicycle test)

  12 and 24 months

• Quality of Life (PDQ-39)

  6, 12, 18 and 24 months

• Mood and Depression (HADS)

  6, 12, 18 and 24 months

Study Arms (2)

A

EXPERIMENTAL

Physical Therapy aimed to promote the level of physical activity

Other: Physical Therapy aimed to improve Physical Activity

B

ACTIVE COMPARATOR

Physical Therapy aimed to move safely

Other: Physical therapy aimed to move safely

Interventions

Physical therapy aimed to move safely 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

B

Physical Therapy aimed to improve Physical Activity 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

A

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Wheel chair bounded
• Severe co-morbidity (e.g. orthopaedic disorders or chronic hart failure)
• Severe cognitive decline, defined as Mini Mental State Examination \< 24

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Michael J. Fox Foundation for Parkinson's Research: collaborator
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (32)

Tergooiziekenhuizen

Hilversum, Postbus 10016, 1201 DA, Netherlands

Location

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, Postbus 1101, 5200 BD, Netherlands

Location

Catharina ziekenhuis

Eindhoven, Postbus 1350, 5602 ZA, Netherlands

Location

Vie Curie Medisch Centrum

Venlo, Postbus 1926, 5900 BX, Netherlands

Location

Hagaziekhuis

The Hague, Postbus 40551, 2504 LN, Netherlands

Location

Medisch Centrum Haaglanden

The Hague, Postbus 432, 2501 CK, Netherlands

Location

Medisch Centrum alkmaar

Alkmaar, Postbus 50, 1800 AM, Netherlands

Location

Maaslandziekenhuis

Sittard, Postbus 5500, 6130 MB, Netherlands

Location

Tergooiziekenhuizen

Blaricum, Postbus 900, 1250 CA, Netherlands

Location

Gelreziekenhuizen

Apeldoorn, Postbus 9014, 7300 DS, Netherlands

Location

Amphia Ziekenhuis

Breda, Postbus 90157, 4800 RL, Netherlands

Location

De Gelreziekenhuizen

Zutphen, Postbus 9020, 7200 GZ, Netherlands

Location

Ziekenhuis Gelderse Vallei

Ede, Postbus 9025, 6710 HN, Netherlands

Location

Elkerliek ziekenhuis

Helmond, Postbus 98, 5700 AB, Netherlands

Location

Reinier de Graaf Groep

Delft, Netherlands

Location

Deventer Ziekenhuis

Deventer, Netherlands

Location

Slingeland Ziekenhuis

Doetinchem, Netherlands

Location

St. Anna Ziekenhuis

Geldrop, Netherlands

Location

Groene Hart Ziekenhuis

Gouda, Netherlands

Location

Kennemer Gasthuis

Haarlem, Netherlands

Location

Atrium Medisch Centrum

Heerlen, Netherlands

Location

Westfriesgasthuis

Hoorn, Netherlands

Location

Academisch Ziekenhuis Maastricht

Maastricht, Netherlands

Location

Ziekenhuis Bernhoven

Oss, Netherlands

Location

Laurentius Ziekenhuis

Roermond, Netherlands

Location

Franciscus Ziekenhuis

Roosendaal, Netherlands

Location

Erasmus Medisch Centrum

Rotterdam, Netherlands

Location

Maasstad Ziekenhuis

Rotterdam, Netherlands

Location

Sint Franciscus Gasthuis

Rotterdam, Netherlands

Location

Vlietland Ziekenhuis

Schiedam, Netherlands

Location

Orbis Medisch Centrum

Sittard, Netherlands

Location

't Lange Land Ziekenhuis

Zoetermeer, Netherlands

Location

Related Publications (2)

• 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.

  PMID: 23457213 DERIVED

• 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.

  PMID: 20723221 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Motor Activity

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavior

Study Officials

• Marten Munneke, Dr.

  UMC st Radboud

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: September 5, 2008
• First Posted: September 8, 2008
• Study Start: September 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: January 31, 2012

Record last verified: 2012-01

Locations

NL (32)