Falls Prevention in Osteoporosis

NCT ID: NCT00432692

Last Updated: 2010-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2009-12-31

Brief Summary

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The purpose of this study is to determine wether a falls prevention program can reduce fall incidence in people with osteoporosis.

Detailed Description

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Falling is a major health problem in the elderly causing physical and psychosocial problems. People with osteoporosis are at higher risk for fractures due to falling, because of decreased bone strength. The 'Nijmegen Falls Prevention Program" (NFPP) (Weerdesteyn et al, 2006) has been shown to reduce fall incidence rates by 46% in healthy community-dwelling elderly. This program was adapted in order to meet the specific demands and constraints of people with osteoporosis.

The contents of the program are an obstacle course, walking exercises, the practice of fall techniques, adjustment of gait abnormalities, weight bearing exercises and educational sessions.

The effectiveness of the program will be evaluated in a randomized clinical trial. Primary outcome measure is fall incidence. Additionally, laboratory assessments of gait and obstacle avoidance will be conducted in conjunction with questionnaires about balance confidence and activity level.

Conditions

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Osteoporosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Falls Prevention Program

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* osteoporosis (DXA T-score \< -2.5 in hip and/or vertebrae)
* able to walk at least 15 minutes without an helping device
* 65 years or older
* community dwelling
* at least one fall in the prior year

Exclusion Criteria

* severe cardiac, pulmonary or musculoskeletal disorders
* pathologies associated with increased fall risks (i.e. stroke or Parkinson's disease)
* use of psychotropic drugs
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

Sponsor Role collaborator

Sint Maartenskliniek

OTHER

Sponsor Role lead

Principal Investigators

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Ellen Smulders, MSc

Role: PRINCIPAL_INVESTIGATOR

Sint Maartenskliniek

Vivian Weerdesteyn, PhD

Role: PRINCIPAL_INVESTIGATOR

Sint Maartenskliniek

Wim van Lankveld, PhD

Role: PRINCIPAL_INVESTIGATOR

Sint Maartenskliniek

Locations

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Sint Maartenskliniek

Nijmegen, , Netherlands

Site Status

Countries

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Netherlands

References

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Smulders E, Weerdesteyn V, Groen BE, Duysens J, Eijsbouts A, Laan R, van Lankveld W. Efficacy of a short multidisciplinary falls prevention program for elderly persons with osteoporosis and a fall history: a randomized controlled trial. Arch Phys Med Rehabil. 2010 Nov;91(11):1705-11. doi: 10.1016/j.apmr.2010.08.004.

Reference Type DERIVED
PMID: 21044715 (View on PubMed)

Other Identifiers

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SMK001

Identifier Type: -

Identifier Source: org_study_id

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