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

NCT01032252 | Completed Phase 4

• 1 other identifier: FAU061209TUM
• Study Type: interventional
• Target: 378
• Locations: 1 country
• Sites: 1

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.

Conditions

Accidental Falls/Prevention & Control; Risk Assessment; General Practitioner Education; Humans; Multicenter Study; Randomized Controlled Trial

Keywords

fall prevention; general practitioners setting; implementation; network; community dwelling older adults; exercise intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (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.

  24 months

Study Arms (2)

observational

NO INTERVENTION

Control group: followed by monthly falls calenders and four testing periods

Exercise group

EXPERIMENTAL

16 week intervention, and followed by monthly fall calenders as well as 4 testing periods

Other: Exercise intervention

Interventions

Exercise intervention OTHER

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.

Exercise group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead
• Technical University of Munich: collaborator

Study Sites (1)

Department of Medicine, Division of Prevention and Sports Medicine TU Munich

Munich, 80809, Germany

Location

Related 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.

  PMID: 21329525 BACKGROUND

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2009
• First Posted: December 15, 2009
• Study Start: April 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: March 1, 2012
• Last Updated: December 14, 2020

Record last verified: 2020-12

Locations

DE (1)