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Fall Prevention in Osteoporosis
This study is currently recruiting participants.
Verified by Sint Maartenskliniek, April 2007
First Received: February 7, 2007   Last Updated: April 16, 2007   History of Changes
Sponsor: Sint Maartenskliniek
Collaborator: ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by: Sint Maartenskliniek
ClinicalTrials.gov Identifier: NCT00432692
  Purpose

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


Condition Intervention
Osteoporosis
Procedure: Fall Prevention Program

Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Placebo Control, Single Group Assignment, Efficacy Study
Official Title: Fall 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)

Estimated Enrollment: 120
Study Start Date: December 2005
Estimated Study Completion Date: December 2008
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00432692

Contacts
Contact: Ellen Smulders Smulders, MSc 0031 24 3659832 e.smulders@maartenskliniek.nl
Contact: Wim van Lankveld, PhD w.vanlankveld@maartenskliniek.nl

Locations
Netherlands
Sint Maartenskliniek Recruiting
Nijmegen, Netherlands, 6522 JV
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

Study ID Numbers: SMK001
Study First Received: February 7, 2007
Last Updated: April 16, 2007
ClinicalTrials.gov Identifier: NCT00432692     History of Changes
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
Musculoskeletal Diseases
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases

ClinicalTrials.gov processed this record on February 08, 2010