Clinical trial NCT00432692: 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
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Keywords: osteoporosis
falls
prevention
elderly
exercise
incidence
obstacle avoidance
Lead sponsor: Sint Maartenskliniek
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2007-02-08
Enrollment: 96
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Fall incidence, which is measured by monthly fall registration cards
Secondary outcomes:
measure: Obstacle avoidance performance
measure: Fear of falling (ABC)
measure: Activity level (LAPAQ)
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Sint Maartenskliniek
Study officials:
affiliation: Sint Maartenskliniek
name: Ellen Smulders, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Sint Maartenskliniek
name: Vivian Weerdesteyn, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sint Maartenskliniek
name: Wim van Lankveld, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.