Prevention of Falls in General Practitioner for Community-dwelling Older Adults [PreFalls]

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: NCT01032252
Recruitment Status : Completed
First Posted : December 15, 2009
Last Update Posted : June 18, 2012
Technische Universität München
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School

Brief Summary:

The primary aim of this two-year project for falls prevention is to reduce number of falls and fall incidence in community-dwelling people of 65 years and older in the setting of general practitioners. In addition a reduction of fall-related injuries, reduction of fall-related risk factors and preservation of Quality of Life is to be achieved.

A second goal of this study is the implementation of standardized assessment for fall risk factors as well as building up a network between instructors for fall prevention exercise and general practitioners.

Condition or disease Intervention/treatment Phase
Accidental Falls/Prevention & Control Risk Assessment General Practitioner Education Humans Multicenter Study Randomized Controlled Trial Other: Exercise intervention Phase 4

Detailed Description:

Health related consequences of falls are underestimated. In comparison to different health related risk factors like hypertension etc. falls and their risks are being underestimated by many physicians. Regardless of the high relevance of falls for the elderly as well as the Health Care System, risk of falling is only rarely being assessed. The reasons for this are manifold. Insufficient assessment of risk of falling are one of the reasons. Many registered doctors with their own practice do not use a standardized assessment of risk of falling that is quick and effective. Additionally, patients rarely report occurred falls to their physicians because they don't know the implications or are afraid of subsequently losing their independence.

Physicians already assessing their senior patients' risk of falling lack the possibility to assign them to according ambulatory interventions since these scarcely exist in Bavaria. Chances for improvement are: standardized assessment of risk of falling needed to uncover senior patients' risk of falling quickly, reliably and efficiently at their family physician's. At the same time area-wide programs to effectively reduce falls by targeting individual behavior as well as general conditions must be provided to maintain the independence of individual senior citizens.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 378 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prevention of Falls in Community-dwelling Older Adults by a Standardized Assessment of Fall Risks in the General Practitioner Setting and Through Implementation of a Network for Effective Individual Reduction on Fall Risks.
Study Start Date : April 2009
Actual Primary Completion Date : September 2011
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: observational
Control group: followed by monthly falls calenders and four testing periods
Experimental: Exercise group
16 week intervention, and followed by monthly fall calenders as well as 4 testing periods
Other: Exercise intervention

16 week exercise once a week of 60 minutes intervention by trained fall prevention instructors and a home program.

Intervention includes strength/power training, balance/gait training, behavioral aspects and perceptual and functional training.

Primary Outcome Measures :
  1. Primary outcomes are number of falls and falls rates as well as number and incidence of injurious falls measured by monthly fall calendars [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Secondary endpoints are a reduction in fear of falling, a reduction in risk of falling in the physical dimensions e.g. strength, balance and function, the preservation of quality of life and the preservation or increase in physical activity. [ Time Frame: 24 months ]

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Target group are community-dwelling senior citizens aged 65 years or above with an increased risk of falling.
  • Increased risk of falling are seen by:

    • history of falls
    • fear of falling
    • chair rise > 10 sec./TUG > 10 sec./ subjective & objective balance deficits

Exclusion Criteria:

  • Elderly people not living independently or suffering from physical or mental restrictions that do not allow the participation in an exercise program or the assessment of risk of falling

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): NCT01032252

Department of Medicine, Division of Prevention and Sports Medicine TU Munich
Munich, Germany, 80809
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Technische Universität München
Principal Investigator: Monika Siegrist, PhD Department of Medicine, Division of Prevention and Sports Medicine TU Munich
Principal Investigator: Ellen Freiberger, PhD Department of Sport Science, University of Erlangen-Nürnberg

Responsible Party: University of Erlangen-Nürnberg Medical School Identifier: NCT01032252     History of Changes
Other Study ID Numbers: FAU061209TUM
FAU061209TUM ( Other Grant/Funding Number: Bavarian State Ministry of the Environment and Public Health )
First Posted: December 15, 2009    Key Record Dates
Last Update Posted: June 18, 2012
Last Verified: June 2012

Keywords provided by University of Erlangen-Nürnberg Medical School:
fall prevention
general practitioners setting
community dwelling older adults
exercise intervention