Indomethacin and Mechanisms Underlying Risk of Falling
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Primary Purpose: Prevention
|Official Title:||Effect of Indomethacin on Reaction Time, Postural Balance and the Ability to Avoid Suddenly Appearing Obstacles During Gait in Healthy Middle-aged Individuals.|
- Success rate on the obstacle avoidance task
- Reaction time
- Root mean square (RMS) of the velocity and amplitude of the centre of pressure (COP)
|Study Start Date:||April 2007|
|Study Completion Date:||September 2007|
|Primary Completion Date:||September 2007 (Final data collection date for primary outcome measure)|
A lot of (epidemiologic) research is done on causes for falls and factors contributing to falling. Most of this research was conducted on the elderly, either community-dwelling or institutionalised. It became clear that the elderly have a greater risk at falling because of:
- physiological changes due to increasing age [Gerdhem et al., 2005]
- previous falls [Myers et al., 1991; Lipsitz et al., 1992]
- comorbidity (including RA) [Bergland et al., 2004; Gerdhem et al., 2005; Lawlor et al., 2003]
- polypharmacy [Lawlor et al., 2003; Walker et al., 2005; Ziere et al., 2005] and/or
- use of specific drugs like antidepressives, benzodiazepines, vasodilators, and NSAIDs [Cumming R, 1998; Herings RMC, 2001; Kallin K et al., 2004; Granek et al., 1987].
The relation between benzodiazepines and falling has been extensively investigated in and affirmed by several fields of research and is practically common sense. However, the (possible) relation between NSAIDs and falling is much less investigated, even though there are various articles in which a higher risk of falling when using NSAIDs is stated; sometimes the risk is even as high as with benzodiazepines [Cumming R, 1998; Granek et al., 1987; Walker et al., 2005].
Objective of the study:
NSAIDs are drugs that are often prescribed to patients with rheumatic or orthopedic diseases. They seem to be at a greater risk for falls than healthy persons because of their disease, age and medication use. Therefore it is very important to keep this risk as small as possible. In this study healthy adults are measured on reaction time, postural balance and obstacle avoidance with and without use of indometacin or placebo. This is done in order to gain more comprehension in the mechanism and actual risk for falls when using NSAIDs.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00462111
|Nijmegen, Netherlands, 6522 JV|
|Principal Investigator:||Jacques van Limbeek, MD||Sint Maartenskliniek|
|Study Chair:||Jaak Duysens, Prof||St Maartenskliniek and University Medical Centre St. Radboud, Nijmegen|