Falls Prevention in Osteoporosis

Not Applicable

Completed

• Conditions: Osteoporosis

• Registration Number: NCT00432692
• Lead Sponsor: Sint Maartenskliniek

Brief Summary

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

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.

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2007-02-07
• Study First Submitted QC: 2007-02-07
• Study First Posted: 2007-02-08
• Status Verified: 2007-04
• Primary Completion: 2009-05
• Study Completion: 2009-12
• Last Update Submitted: 2010-02-24
• Last Update Posted: 2010-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Fall incidence, which is measured by monthly fall registration cards

Secondary Outcome Measures

Name	Time	Method
Obstacle avoidance performance
Fear of falling (ABC)
Activity level (LAPAQ)

Trial Locations

Locations (1)

Sint Maartenskliniek; 🇳🇱 Nijmegen, Netherlands