Falls Prevention in Osteoporosis

Osteoporosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00432692
• Other study ID #: SMK001
• Status: Completed
• Phase: N/A
• First received: February 7, 2007
• Last updated: February 24, 2010
• Start date: December 2005
• Est. completion date: December 2009

Study information

• Verified date: April 2007
• Source: Sint Maartenskliniek
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: December 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Procedure:
• Falls Prevention Program

Locations

Country	Name	City	State
Netherlands	Sint Maartenskliniek	Nijmegen

Sponsors (2)

Lead Sponsor	Collaborator
Sint Maartenskliniek	ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fall incidence, which is measured by monthly fall registration cards
Secondary	Obstacle avoidance performance
Secondary	Fear of falling (ABC)
Secondary	Activity level (LAPAQ)