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

Sponsor

University of Erlangen-Nürnberg Medical School (Other)

Overall Status

Completed

CT.gov ID

NCT01032252

Collaborator

Technische Universität München (Other)

378

Enrollment

Location

Arms

Duration (Months)

10.8

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

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 :

Apr 1, 2009

Actual Primary Completion Date :

Sep 1, 2011

Actual Study Completion Date :

Mar 1, 2012

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

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