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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01032252
Other study ID # FAU061209TUM
Secondary ID FAU061209TUM
Status Completed
Phase Phase 4
First received
Last updated
Start date April 2009
Est. completion date March 2012

Study information

Verified date December 2020
Source University of Erlangen-Nürnberg Medical School
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 378
Est. completion date March 2012
Est. primary completion date September 2011
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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

Study Design


Intervention

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.

Locations

Country Name City State
Germany Department of Medicine, Division of Prevention and Sports Medicine TU Munich Munich

Sponsors (2)

Lead Sponsor Collaborator
University of Erlangen-Nürnberg Medical School Technische Universität München

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Blank WA, Freiberger E, Siegrist M, Landendoerfer P, Linde K, Schuster T, Pfeifer K, Schneider A, Halle M. An interdisciplinary intervention to prevent falls in community-dwelling elderly persons: protocol of a cluster-randomized trial [PreFalls]. BMC Geriatr. 2011 Feb 17;11:7. doi: 10.1186/1471-2318-11-7. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Primary outcomes are number of falls and falls rates as well as number and incidence of injurious falls measured by monthly fall calendars 24 months
Secondary 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. 24 months
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