A Phase 4 interventional study of Caffeine in Healthy and Elderly, sponsored by Herning Hospital. Completed at 1 site in Denmark. Open to participants aged 70 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-01-13.
Sponsored by Herning Hospital · Phase 4, Interventional, and Treatment
The study investigated the effect of caffeine on physical performance in healthy citizens aged over 70 years following eight hours of abstinence from caffeine containing drinks and foods. The main hypothesis was that 6 mg/kg caffeine would improve cycling endurance at 65% of expected maximal heart rate.
It is well documented that caffeine ingestion increases the endurance of young people exercising at 60%-85% of their maximal oxygen uptake (13;15;47). It also seems to improve endurance as measured by repeated sub-maximal isometric contraction (42), and decreases the rate of perceived exertion during exercise (6;9;46). Typically, doses of approximately 6 mg/kg caffeine were used in these studies.
With a growing number of elderly with a physical active lifestyle and many elderly participating in rehabilitation programs the endurance enhancing effect of caffeine is of increasing interest in this age group. We therefore conducted a study of healthy 75 year old citizens to investigate whether 6 mg/kg caffeine improved physical performance and reduced the perceived effort during work in healthy citizens aged ≥ 70 years. The main hypothesis was that caffeine would improve cycling endurance at 65% of expected maximal heart rate. The study showed that compared to placebo caffeine increased endurance by 25 % (p\<0.0001) and isometric sub-maximal strength with 54 % (p\<0.0001), reduced perceived exertion after 5 minutes of biking by 11 % (p=0.002), but in 21 of 30 participants there was reduced postural stability (with eyes open). In the above described study participants abstained from caffeine containing drinks and foods for 48 hours prior to each test. Half of the participants reported withdrawal symptoms. Such a long caffeine abstinence period would infer with daily life for many people. We therefore invited the participants from the above study to a repetition of the above study to test whether similar results would be obtained if participants only abstained from caffeine containing drinks and foods for 8 hours prior to each test.
Herning Hospital is the lead sponsor of 21 studies on the registry; none are open to participants now.
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Drug: Caffeine
Drug: Caffeine
Caffeine capsule 6 mg/kg given 1 hour before test
Also known as: Identical looking placebo capsule given 1 hour before test
Endurance measured on an ergometer bicycle
Time frame: The tests started 1 h following placebo/caffeine
Isometric endurance (arm flexion)
Time frame: The tests started 1 h following placebo/caffeine
Isometric maximum arm flexion strength
Time frame: The tests started 1 h following placebo/caffeine
Fatigue (Borg scale) during ergometer test
Time frame: After 5 minutes biking and at exhaustion
Postural stability
Time frame: The tests started 1 h following placebo/caffeine
Reaction time
Time frame: The tests started 1 h following placebo/caffeine
Walking speed
Time frame: The tests started 1 h following placebo/caffeine
Biochemistry: lactate, catecholamines, insulin, free fatty acids, glucose
Time frame: Before intervention; before cycling; after 5 minutes of cycling; and at exhaustion
Withdrawal symptoms
Time frame: At the end of each test
Side effects
Time frame: At the end of each test
The record gives a start of Feb 2005 and a primary completion of Nov 2005. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jan 2010. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Caffeine
Herning Hospital