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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00117520
Other study ID # 2612-1987
Secondary ID
Status Completed
Phase Phase 4
First received June 30, 2005
Last updated July 3, 2006
Start date July 2002
Est. completion date March 2006

Study information

Verified date July 2002
Source Herning Hospital
Contact n/a
Is FDA regulated No
Health authority Denmark: National Board of Health
Study type Interventional

Clinical Trial Summary

The study investigated the effect of caffeine on physical performance in healthy citizens aged over 70 years. The main hypothesis was that 6 mg/kg caffeine would improve cycling endurance at 65% of expected maximal heart rate.


Description:

Caffeine ingestion increases the endurance of young people exercising at 60%-85% of their maximal oxygen uptake, and it also seems to improve endurance as measured by repeated sub-maximal isometric contraction and decreases the rate of perceived exertion during exercise. Although caffeine increases endurance in young people, an increase in endurance may be of greater interest in the elderly as the population of older adults with a physically active lifestyle is growing rapidly or for increasing endurance fitness through an exercise or rehabilitation program. Therefore the main hypothesis was that caffeine would improve cycling endurance at 65% of expected maximal heart rate, and the secondary hypotheses were that caffeine would improve postural stability, reaction and movement times, isometric arm flexion endurance, and walking speed, and would reduce the rate of perceived exertion after 5 minutes of cycling in healthy elderly citizens.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date March 2006
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 70 Years and older
Eligibility Inclusion Criteria:

- Healthy elderly individuals aged over 70 years

Exclusion Criteria:

- Dementia or invalidating psychiatric disease

- General debility, angina, or other diseases that would render participation in the test program impossible

- Treatment with beta receptor blocking drugs, calcium-channel blocking drugs, digitalis, or nitroglycerine

- Acute disease and injury

- Diabetes

- Conditions that would contraindicate caffeine ingestion or participation in the test program

- Treatment with medication that interacts with caffeine

- Ingestion of caffeine containing drinks and foods 48 hours before each session

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Caffeine


Locations

Country Name City State
Denmark Surgical Research Department Herning Ringkjoebing

Sponsors (1)

Lead Sponsor Collaborator
Herning Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary endurance measured on an ergometer bicycle
Secondary postural stability
Secondary reactiontime
Secondary isometric endurance (armflexion)
Secondary walking speed
Secondary fatigue