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

December 10, 2020 updated by: University of Erlangen-Nürnberg Medical School

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

378

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Munich, Germany, 80809
        • Department of Medicine, Division of Prevention and Sports Medicine TU Munich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Erlangen-Nürnberg Medical School

Collaborators

Technical University of Munich

Investigators

  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

December 12, 2009

First Submitted That Met QC Criteria

December 12, 2009

First Posted (Estimate)

December 15, 2009

Study Record Updates

Last Update Posted (Actual)

December 14, 2020

Last Update Submitted That Met QC Criteria

December 10, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FAU061209TUM (Other Grant/Funding Number: Bavarian State Ministry of the Environment and Public Health)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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