Reduction of Falls in the Elderly - Parkinson's Disease (REFINE-PD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00518648
Recruitment Status : Completed
First Posted : August 21, 2007
Last Update Posted : November 23, 2010
National Parkinson Foundation
Information provided by:
Radboud University

Brief Summary:
The REFINE-PD study is a controlled trial embedded within a larger cluster controlled study (the IMPACT study). The study aims to investigate the efficacy of a multifactorial falls prevention program for patients with Parkinson's Disease (PD). This program contains PD-specific elements (e.g., optimizing dopaminergic therapy), plus a generic falls prevention program. The intervention will be tailored to each individual's specific risk profile for falls, as identified during detailed baseline examination.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Other: Multifactorial fall prevention program Other: Usual care Phase 3

Detailed Description:

Falls and postural instability are common complications of advanced Parkinson's Disease (PD). Falls in PD often have devastating consequences, leading to a poor overall prognosis. In addition, falls in PD are associated with substantial medical expenses due to treatment of injuries and nursing home admission. The risk of falls in older PD patients is aggravated by "generic" age-related factors, such as sedative medication or poor vision. Observations on elderly persons without PD suggest that a multifactorial prevention program might be more effective. We propose to investigate the effectiveness of a multifactorial prevention program aimed at the prevention of falls in PD, which is based on disease-specific treatment strategies with demonstrated efficacy in PD, as well as prevention strategies with proven effectiveness for the general elderly population.

In this study an individualised multifactorial program aimed at the prevention of falls in PD containing PD-specific elements and a generic falls prevention program will be compared to usual care.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 187 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Reduction of Falls in the Elderly - Parkinson's Disease
Study Start Date : August 2007
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: I
Multifactorial fall prevention program
Other: Multifactorial fall prevention program
Individualised multifactorial fall prevention program containing PD-specific elements as well as generic elements
Usual care
Other: Usual care
Usual care

Primary Outcome Measures :
  1. Incidence of falls [ Time Frame: 8 months ]

Secondary Outcome Measures :
  1. Number of fallers (secondary) [ Time Frame: 8 months ]
  2. Falls Efficacy Scale (tertiary) [ Time Frame: 8 months ]
  3. Unified Parkinson's Disease rating scale (UPDRS) Motor Examination (part III) (tertiary) [ Time Frame: 4 months ]
  4. Parkinson's Disease quality of life questionnaire (PDQL) (tertiary) [ Time Frame: 8 months ]
  5. Self-assessment Parkinson's Disease disability scale (SPDDS)(tertiary) [ Time Frame: 8 months ]
  6. Caregiver burden assessed with BELA-A-k, SF-36, and HADS (tertiary) [ Time Frame: 8 months ]
  7. Number of injurious falls (secondary) [ Time Frame: 8 months ]
  8. Number of patients with injurious falls (secondary) [ Time Frame: 8 months ]
  9. Freezing of gait (tertiary) [ Time Frame: 8 months ]
  10. Costs (secondary) [ Time Frame: 8 months ]

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with idiopathic Parkinson's Disease, diagnosed according to the Brain Bank criteria of the UK Parkinson's Society
  • Regular control by the neurologist
  • Living independently in the community
  • Able to complete the trial questionnaires
  • An increased risk for falling, defined as:

    • at least one fall in the preceding 12 months OR
    • recurrent (monthly) near falls in the preceding 12 months OR
    • fear of falling OR (iv) avoidance of activities due to fear of falling OR a combination of these findings

Exclusion Criteria:

  • Atypical parkinsonian syndromes
  • Hoehn and Yahr stage 5
  • Severe cognitive impairment (MMSE < 24)
  • Severe co-morbidity (e.g., cancer)
  • Planned surgical procedure for PD within the intervention period
  • Patients who have already visited the Multidisciplinary Assessment Center

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00518648

Ziekenhuis Groep Twente, Twenteborg Ziekenhuis
Almelo, Netherlands
Ziekenhuis Rijnstate
Arnhem, Netherlands
Wilhelmina Ziekenhuis Assen
Assen, Netherlands
Ziekenhuis Groep Twente, Streekziekenhuis Midden-Twente
Hengelo, Netherlands
Medisch Centrum Leeuwarden
Leeuwarden, Netherlands
Canisius Wilhelmina Ziekenhuis
Nijmegen, Netherlands
Sponsors and Collaborators
Radboud University
National Parkinson Foundation
Principal Investigator: Marten Munneke, PhD UMC St. Radboud
Principal Investigator: Bastiaan R. Bloem, MD, PhD UMC St. Radboud
Principal Investigator: Marjolein A. van der Marck, MSc UMC St. Radboud

Responsible Party: Dr. M. Munneke, UMC St Radboud, Neurology Identifier: NCT00518648     History of Changes
Other Study ID Numbers: 2007_RP1.1
First Posted: August 21, 2007    Key Record Dates
Last Update Posted: November 23, 2010
Last Verified: November 2010

Keywords provided by Radboud University:
Accidental falls
Treatment effectiveness

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases