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| Sponsor: | Sint Maartenskliniek |
|---|---|
| Collaborator: |
ZonMw: The Netherlands Organisation for Health Research and Development |
| Information provided by: | Sint Maartenskliniek |
| ClinicalTrials.gov Identifier: | NCT00432692 |
Purpose
The purpose of this study is to determine wether a fall prevention program can reduce fall incidence in people with osteoporosis.
| Condition | Intervention |
|---|---|
|
Osteoporosis |
Procedure: Fall Prevention Program |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Open Label, Placebo Control, Single Group Assignment, Efficacy Study |
| Official Title: | Fall Prevention for People With Increased Risk of Fractures as a Result of Osteoporosis: a Randomized Controlled Study on the Effects of a Modified Program |
| Estimated Enrollment: | 120 |
| Study Start Date: | December 2005 |
| Estimated Study Completion Date: | December 2008 |
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:
Exclusion Criteria:
Contacts and Locations| Contact: Ellen Smulders Smulders, MSc | 0031 24 3659832 | e.smulders@maartenskliniek.nl |
| Contact: Wim van Lankveld, PhD | w.vanlankveld@maartenskliniek.nl |
| Netherlands | |
| Sint Maartenskliniek | Recruiting |
| Nijmegen, Netherlands, 6522 JV | |
| Principal Investigator: | Ellen Smulders, MSc | Sint Maartenskliniek |
| Principal Investigator: | Vivian Weerdesteyn, PhD | Sint Maartenskliniek |
| Principal Investigator: | Wim van Lankveld, PhD | Sint Maartenskliniek |
More Information
| Study ID Numbers: | SMK001 |
| Study First Received: | February 7, 2007 |
| Last Updated: | April 16, 2007 |
| ClinicalTrials.gov Identifier: | NCT00432692 History of Changes |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
|
osteoporosis falls prevention elderly |
exercise incidence obstacle avoidance |
|
Osteoporosis Musculoskeletal Diseases Osteoporosis, Postmenopausal Bone Diseases, Metabolic Bone Diseases |