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Falls Prevention in Osteoporosis

This study has been completed.
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by:
Sint Maartenskliniek
ClinicalTrials.gov Identifier:
NCT00432692
First received: February 7, 2007
Last updated: February 24, 2010
Last verified: April 2007
  Purpose

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


Condition Intervention
Osteoporosis
Procedure: Falls Prevention Program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Falls Prevention for People With Increased Risk of Fractures as a Result of Osteoporosis: a Randomized Controlled Study on the Effects of a Modified Program

Resource links provided by NLM:


Further study details as provided by Sint Maartenskliniek:

Primary Outcome Measures:
  • Fall incidence, which is measured by monthly fall registration cards

Secondary Outcome Measures:
  • Obstacle avoidance performance
  • Fear of falling (ABC)
  • Activity level (LAPAQ)

Enrollment: 96
Study Start Date: December 2005
Study Completion Date: December 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00432692

Locations
Netherlands
Sint Maartenskliniek
Nijmegen, Netherlands
Sponsors and Collaborators
Sint Maartenskliniek
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
Principal Investigator: Ellen Smulders, MSc Sint Maartenskliniek
Principal Investigator: Vivian Weerdesteyn, PhD Sint Maartenskliniek
Principal Investigator: Wim van Lankveld, PhD Sint Maartenskliniek
  More Information

No publications provided by Sint Maartenskliniek

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00432692     History of Changes
Other Study ID Numbers: SMK001
Study First Received: February 7, 2007
Last Updated: February 24, 2010
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Sint Maartenskliniek:
osteoporosis
falls
prevention
elderly
exercise
incidence
obstacle avoidance

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases
Bone Diseases, Metabolic
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on November 24, 2014