Falls Prevention in Osteoporosis
Primary Purpose
Osteoporosis
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Falls Prevention Program
Sponsored by
About this trial
This is an interventional prevention trial for Osteoporosis focused on measuring osteoporosis, falls, prevention, elderly, exercise, incidence, obstacle avoidance
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
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
NCT ID
NCT00432692
First Posted
February 7, 2007
Last Updated
February 24, 2010
Sponsor
Sint Maartenskliniek
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
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
Learn more about this trial
Falls Prevention in Osteoporosis
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