Falls Prevention in Osteoporosis
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Purpose
The purpose of this study is to determine wether a falls prevention program can reduce fall incidence in people with osteoporosis.
| Condition | Intervention |
|---|---|
|
Osteoporosis |
Procedure: Falls Prevention Program |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| 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 |
- Fall incidence, which is measured by monthly fall registration cards
- Obstacle avoidance performance
- Fear of falling (ABC)
- Activity level (LAPAQ)
| Enrollment: | 96 |
| Study Start Date: | December 2005 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
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 |
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| Netherlands | |
| Sint Maartenskliniek | |
| Nijmegen, Netherlands | |
| 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 by Sint Maartenskliniek
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00432692 History of Changes |
| Other Study ID Numbers: | SMK001 |
| Study First Received: | February 7, 2007 |
| Last Updated: | February 24, 2010 |
| 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 Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on May 21, 2013