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Falls Prevention in Osteoporosis

Primary Purpose

Osteoporosis

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Falls Prevention Program
Sponsored by
Sint Maartenskliniek
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteoporosis focused on measuring osteoporosis, falls, prevention, elderly, exercise, incidence, obstacle avoidance

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sint Maartenskliniek

Outcomes

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)

Full Information

First Posted
February 7, 2007
Last Updated
February 24, 2010
Sponsor
Sint Maartenskliniek
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT00432692
Brief Title
Falls Prevention in Osteoporosis
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sint Maartenskliniek
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
osteoporosis, falls, prevention, elderly, exercise, incidence, obstacle avoidance

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Falls Prevention Program
Primary Outcome Measure Information:
Title
Fall incidence, which is measured by monthly fall registration cards
Secondary Outcome Measure Information:
Title
Obstacle avoidance performance
Title
Fear of falling (ABC)
Title
Activity level (LAPAQ)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ellen Smulders, MSc
Organizational Affiliation
Sint Maartenskliniek
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vivian Weerdesteyn, PhD
Organizational Affiliation
Sint Maartenskliniek
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wim van Lankveld, PhD
Organizational Affiliation
Sint Maartenskliniek
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sint Maartenskliniek
City
Nijmegen
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
21044715
Citation
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.
Results Reference
derived

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Falls Prevention in Osteoporosis

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