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…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
gezonde proefpersonen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Successrate on the obstacle avoidance task.
Secondary outcome
Reactiontime
Root Mean Square (RMS) of the velocity and amplitude of the Centre of Pressure
(COP)
Background summary
A lot of (epidemiologic) research is done on causes for falls and factors
contributing to falling. Most of this research was conducted on elderly, either
community-dwelling or institutionalised. It became clear that 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, vasodilatators
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].
Study objective
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 reactiontime, postural balance and obstacle avoidance with and
without a single dose of indometacine or placebo. This is done in order to gain
more comprehension in the mechanism and actual risk for falls when using
NSAIDs.
Study design
Doubleblind placebo-controlled cross-over design.
Study burden and risks
The subjects will be measured four times for 3 hours and it will not bring them
any benefits. There is a minimal risk for side effects (especially
gastro-intestinal problems) of indometacin. Provided that these side effects
will occur anyway, they will last for a short time and will be treated
adequately by the investigator. The risk for injuries caused by the tasks is
minimal as well; falls will be prevented by means of a safety harness or
handrails.
Hengstdal 3
6522 JV NIJMEGEN
Nederland
Hengstdal 3
6522 JV NIJMEGEN
Nederland
Listed location countries
Age
Inclusion criteria
- age between 50-70
- not using any NSAIDs for at least 3 days prior to the test session
Exclusion criteria
- neurological or orthopedic disorders
- poor comprehension of Dutch language
- hearing problems
- severe problems with heart and/or bloodvessels
- acutely existing Ulcus ventriculi and/or duodeni, or history of Ulcus
- allergy against Indomethacin, Aspirin, or other NSAIDs
- patients with nasal polyps reacting with an angioedema to other NSAIDS
- severe preexisting renal and liver damage
- comedication
- over 100kg of weight
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
EudraCT | EUCTR2006-005324-17-NL |
CCMO | NL14489.091.06 |