NCT00117520

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2002

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

June 30, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 7, 2005

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

July 7, 2006

Status Verified

July 1, 2002

First QC Date

June 30, 2005

Last Update Submit

July 3, 2006

Conditions

Healthy Elderly Citizens

Keywords

caffeine, endurance, postural stability, elderly

Outcome Measures

Primary Outcomes (1)

  • endurance measured on an ergometer bicycle

Secondary Outcomes (5)

  • postural stability

  • reactiontime

  • isometric endurance (armflexion)

  • walking speed

  • fatigue

Interventions

CaffeineDRUG

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Healthy elderly individuals aged over 70 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Surgical Research Department

Herning, Ringkjoebing, 7400, Denmark

Location

MeSH Terms

Interventions

Caffeine

Intervention Hierarchy (Ancestors)

XanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Charlotte B Norager, M.D

    Surgical Research Department, Herning Hospital, DK-7400 Herning

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 30, 2005

First Posted

July 7, 2005

Study Start

July 1, 2002

Study Completion

March 1, 2006

Last Updated

July 7, 2006

Record last verified: 2002-07

Locations

DK(1)