Indomethacin and Mechanisms Underlying Risk of Falling
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Purpose
The purpose of this study is to determine whether indometacin has an effect on reaction time, postural stability, and the avoidance of obstacles.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Indometacin |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Double-Blind 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)
| Estimated Enrollment: | 20 |
| 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.
Eligibility| Ages Eligible for Study: | 50 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Age between 50-70 years old
- Not using any non-steroidal anti-inflammatory drugs (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 blood vessels
- 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
- Co-medication
- Over 100 kg of weight
Contacts and Locations| Netherlands | |
| Sint Maartenskliniek | |
| 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 |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00462111 History of Changes |
| Other Study ID Numbers: | SKM002 |
| Study First Received: | April 16, 2007 |
| Last Updated: | February 13, 2012 |
| Health Authority: | Netherlands: Medical Ethics Review Committee (METC) |
Keywords provided by Sint Maartenskliniek:
|
indometacin reaction time postural balance obstacle avoidance accidental falls |
Additional relevant MeSH terms:
|
Indomethacin Gout Suppressants Antirheumatic Agents Therapeutic Uses Pharmacologic Actions Tocolytic Agents Reproductive Control Agents Physiological Effects of Drugs Cyclooxygenase Inhibitors Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Anti-Inflammatory Agents Cardiovascular Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 19, 2013