Healthy Elderly CitizensPhase 4NCT00117520
The Effect of Caffeine in Elderly Citizens
A Phase 4 study testing Caffeine in people with Healthy Elderly Citizens, run by Herning Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Elderly Citizens
- What is being tested?
- Caffeine
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- Jul 2002to Mar 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Healthy elderly individuals aged over 70 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Caffeine as Endurance Enhancing Drug in the Elderly
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.
Read the 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.
- Conditions
- Healthy Elderly Citizens
- Being tested
- Caffeine
- Keywords
- caffeine, endurance, postural stability, elderly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaffeineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
endurance measured on an ergometer bicycle
Secondary outcomes (5)
postural stability
reactiontime
isometric endurance (armflexion)
walking speed
fatigue
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2005 (estimated)
- Study startJul 2002
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Elderly CitizensStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Herning Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Charlotte B Norager, M.D, Principal investigator, Surgical Research Department, Herning Hospital, DK-7400 Herning
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00117520
- Sponsor's protocol ID
- 2612-1987
- Status last verified
- Jul 2002
- First submitted
- 30 Jun 2005
- Last updated
- 7 Jul 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Caffeine as Endurance Enhancing Drug in the Elderly
- ClinicalTrials.gov ID
- NCT00117520
- Acronym / sponsor ID
- 2612-1987
- Conditions
- Healthy Elderly Citizens
- Keywords
- caffeine, endurance, postural stability, elderly
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- Herning HospitalUniversity, hospital or other
- Study start
- Jul 2002
- Study completion
- Mar 2006
- First posted
- 7 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Healthy elderly individuals aged over 70 years
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caffeine | Drug | – |
Primary outcome
endurance measured on an ergometer bicycle
5 secondary outcomes
postural stability
reactiontime
isometric endurance (armflexion)
walking speed
fatigue
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2006.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charlotte B Norager, M.D principal investigator
Surgical Research Department, Herning Hospital, DK-7400 Herning
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Caffeine in people with Healthy Elderly Citizens, run by Herning Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
endurance measured on an ergometer bicycle. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2006.