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The Effect of Caffeine in Elderly Citizens

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00117520
Recruitment Status : Completed
First Posted : July 7, 2005
Last Update Posted : July 7, 2006
Sponsor:
Information provided by:
Herning Hospital

Tracking Information
First Submitted Date  ICMJE June 30, 2005
First Posted Date  ICMJE July 7, 2005
Last Update Posted Date July 7, 2006
Study Start Date  ICMJE July 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: July 3, 2006)
endurance measured on an ergometer bicycle
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2006)
  • postural stability
  • reactiontime
  • isometric endurance (armflexion)
  • walking speed
  • fatigue
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Caffeine in Elderly Citizens
Official Title  ICMJE The Effect of Caffeine as Endurance Enhancing Drug in the Elderly
Brief 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.
Detailed 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Healthy Elderly Citizens
Intervention  ICMJE Drug: Caffeine
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June 30, 2005)
30
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE March 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 70 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00117520
Other Study ID Numbers  ICMJE 2612-1987
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Herning Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Charlotte B Norager, M.D Surgical Research Department, Herning Hospital, DK-7400 Herning
PRS Account Herning Hospital
Verification Date July 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP