Intermittent ClaudicationPhase 3NCT00388128
Caffeine and Intermittent Claudication
A Phase 3 study testing Caffeine 6mg/kg in people with Intermittent Claudication, run by University of Aarhus at 1 site in Denmark.
Trial summary
The purpose of this study is to evaluate the change in Walking capacity after an intake of caffeine. The study design is cross-over and follow-up of 80 patients with leg pain caused by narrowing of their leg arteries, Peripheral Vascular Disease (PAD), stage II. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Intermittent Claudication
- What is being tested?
- Caffeine 6mg/kg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2006to Sep 2009
- Phase
- Phase 3
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- men and women > 40 years
- history of IC of the lower extremities, Fontaine II
- ankle-brachial index (ABI)> 0.9 (subjects who are referred for a revasularizarition procedure)
Who cannot join
- dementia
- diabetes
- illness or reason to be unable to participate, f.ex. general weakness, amputation or arthritis
- acute illness, f.ex. inflammation, unstable angina
- other reasons which contraindicate participation/treadmill exercise
- intake of Trental and/or Teofyllamin
- weight > 100kg
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Herning Hospital, Surgical research dep.
Herning, Central Jutland, 7400
About this study
Official title: Effects of Caffeine in Patients With Intermittent Claudication.
The purpose of this study is to evaluate the change in Walking capacity after an intake of caffeine. The study design is cross-over and follow-up of 80 patients with leg pain caused by narrowing of their leg arteries, Peripheral Vascular Disease (PAD), stage II. Half of all will be revascularised, follow up will be after 3 months. It is hypothesized that caffeine (6mg/kg) can be a cheap, safe drug before walking exercise. Primary endpoint is maximum walking distance (MWD), treadmill-testing,(constant load, 0%,2m/h). Secondary endpoints are pain free walking distance (PWD), maximum muscle strength, endurance, reaction speed, balance, cognitive function, health related quality of life (SF-36).
Read the detailed description
PAD has a prevalence of 15-20 % in an elderly (>50) western population. PAD can not be seen in isolation but represents the peripheral manifestation of a generalized artherosclerosis. The co-morbidity with coronary or cerebralartherosclerosis depends on the degree of severity of PAD, the relative risk of a death (predominantly cardiac) is increased by a factor 4. From af medical and a socio-economic point of view there is the need to control the PAD complication rate and related treatment costs as effectively as possible.
The aim of any treatment of intermittent claudication is a clinically relevant improvement in the patient´s mobility and quality of life.
There is agreement, that physical training does improve the collateralisation of vascular lesions, the rheologic properties of blood and lead to a shift from glycolytic to oxidative muscle fibers in the working musculature which increases the capillary density. The effect of physical training is also to modify the patients risk factor profile, even moderate training increase the insulin receptor sensitivity and the fibrinolytic activity and decrease the dLDL/HDL ratio and the diastolic blood pressure in hypertensive patients - and thereby decrease the overall cardiac mortality.
This is a Phase 3, 12-week, double-blind, randomized, placebo-controlled cross-over and a follow-up study with 80 patients with intermittent claudication, half of which will be revascularized.
The objectives of this study are to evaluate the efficacy of caffeine (6mg/kg)and the revascularisation procedure. The primary end-point will be maximal walking distance (MWD) in both groups of patients. Other efficacy measures will include claudication onset time (PWD), changes in Ankle Brachial Index (ABI), Quality of Life (QoL), cognitive function, plasma response of Vascular Endothelian Growth Factor (VEGF, FGF). Safety variables will include routine hematology parameters and adverse events.
- Conditions
- Intermittent Claudication
- Being tested
- Caffeine 6mg/kg
- Keywords
- Intermittent Claudication, PAD, Caffeine, Walking capacity, ABI, QoL, Growth factor
- Medical subject headings
- Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caffeine 6mg/kgDrug
Capsules of caffeine 6 mg/kg, taken orally at each test. Before and after treadmill testing
| Study group | Role | What they receive |
|---|---|---|
| A | Placebo comparator | Not described Receives: Drug: Caffeine 6mg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
Measured: during test 1 and 3
Maximum walking distance
Measured: during treadmill test
Secondary outcomes (8)
Painfree Walking Distance
Measured: treadmill test
Max muscle strength (MVC) of kneeextension
Measured: At end of each test
Endurance of 50%MVC kneeextension
Measured: At end of each test
Postural stability
Measured: in all tests
Reaction speed
Measured: in all tests
Cognitive function
Measured: in all tests
Walking Impairment Questionnaire
Measured: in first and third test
vascular endothelian growth factors VGF. FGF
Measured: before and after 1. and 2. test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2006 (estimated)
- Study startSep 2006
- Primary completionMay 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intermittent ClaudicationStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Herning Hospital, Central Jutland Regional Hospital
- Investigators
- Anne-Mette H Momsen, MPH, Phys, ph.D stud, Principal investigator, Herning Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00388128
- Sponsor's protocol ID
- 2006-001902-10
- Other IDs
- 2006/168
- Status last verified
- Jun 2011
- First submitted
- 12 Oct 2006
- Last updated
- 9 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Momsen AH, Jensen MB, Norager CB, Madsen MR, Vestersgaard-Andersen T, Lindholt JS. Randomized double-blind placebo-controlled crossover study of caffeine in patients with intermittent claudication. Br J Surg. 2010 Oct;97(10):1503-10. doi: 10.1002/bjs.7149.
PubMed 20629111
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Caffeine in Patients With Intermittent Claudication.
- ClinicalTrials.gov ID
- NCT00388128
- Acronym / sponsor ID
- 2006-001902-10
- Conditions
- Intermittent Claudication
- Keywords
- Intermittent Claudication, PAD, Caffeine, Walking capacity, ABI, QoL, Growth factor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Herning Hospital, Central Jutland Regional Hospital
- Study start
- Sep 2006
- Primary completion
- May 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 13 Oct 2006 (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 purpose of this study is to evaluate the change in Walking capacity after an intake of caffeine. The study design is cross-over and follow-up of 80 patients with leg pain caused by narrowing of their leg arteries, Peripheral Vascular Disease (PAD), stage II. Half of all will be revascularised, follow up will be after 3 months. It is hypothesized that caffeine (6mg/kg) can be a cheap, safe drug before walking exercise. Primary endpoint is maximum walking distance (MWD), treadmill-testing,(constant load, 0%,2m/h). Secondary endpoints are pain free walking distance (PWD), maximum muscle strength, endurance, reaction speed, balance, cognitive function, health related quality of life (SF-36).
Detailed description
PAD has a prevalence of 15-20 % in an elderly (>50) western population. PAD can not be seen in isolation but represents the peripheral manifestation of a generalized artherosclerosis. The co-morbidity with coronary or cerebralartherosclerosis depends on the degree of severity of PAD, the relative risk of a death (predominantly cardiac) is increased by a factor 4. From af medical and a socio-economic point of view there is the need to control the PAD complication rate and related treatment costs as effectively as possible.
The aim of any treatment of intermittent claudication is a clinically relevant improvement in the patient´s mobility and quality of life.
There is agreement, that physical training does improve the collateralisation of vascular lesions, the rheologic properties of blood and lead to a shift from glycolytic to oxidative muscle fibers in the working musculature which increases the capillary density. The effect of physical training is also to modify the patients risk factor profile, even moderate training increase the insulin receptor sensitivity and the fibrinolytic activity and decrease the dLDL/HDL ratio and the diastolic blood pressure in hypertensive patients - and thereby decrease the overall cardiac mortality.
This is a Phase 3, 12-week, double-blind, randomized, placebo-controlled cross-over and a follow-up study with 80 patients with intermittent claudication, half of which will be revascularized.
The objectives of this study are to evaluate the efficacy of caffeine (6mg/kg)and the revascularisation procedure. The primary end-point will be maximal walking distance (MWD) in both groups of patients. Other efficacy measures will include claudication onset time (PWD), changes in Ankle Brachial Index (ABI), Quality of Life (QoL), cognitive function, plasma response of Vascular Endothelian Growth Factor (VEGF, FGF). Safety variables will include routine hematology parameters and adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Placebo comparator | Drug: Caffeine 6mg/kg |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- men and women > 40 years
- history of IC of the lower extremities, Fontaine II
- ankle-brachial index (ABI)> 0.9 (subjects who are referred for a revasularizarition procedure)
Key exclusion criteria (7 listed)
- dementia
- diabetes
- illness or reason to be unable to participate, f.ex. general weakness, amputation or arthritis
- acute illness, f.ex. inflammation, unstable angina
- other reasons which contraindicate participation/treadmill exercise
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 6mg/kgCapsules of caffeine 6 mg/kg, taken orally at each test. Before and after treadmill testing | Drug | A |
Primary outcome
Quality of life
Time frame: during test 1 and 3
Maximum walking distance
Time frame: during treadmill test
8 secondary outcomes
Painfree Walking Distance
Time frame: treadmill test
Max muscle strength (MVC) of kneeextension
Time frame: At end of each test
Endurance of 50%MVC kneeextension
Time frame: At end of each test
Postural stability
Time frame: in all tests
Reaction speed
Time frame: in all tests
Cognitive function
Time frame: in all tests
Walking Impairment Questionnaire
Time frame: in first and third test
vascular endothelian growth factors VGF. FGF
Time frame: before and after 1. and 2. test
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 9 Jun 2011.
- Derived from this study: PubMed 20629111Momsen AH, Jensen MB, Norager CB, Madsen MR, Vestersgaard-Andersen T, Lindholt JS. Randomized double-blind placebo-controlled crossover study of caffeine in patients with intermittent claudication. Br J Surg. 2010 Oct;97(10):1503-10. doi: 10.1002/bjs.7149.
Related trials for Intermittent Claudication
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Personalised Multicomponent Exercise Programme in Peripheral Arterial Disease
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Active, not recruitingPhase 4
Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis
Peripheral Arterial Disease
Recruiting
EVERO Drug-coated Balloon (DCB) Randomized Trial
Peripheral Vascular Disease, Peripheral Arterial Disease
RecruitingPhase 3
Improving Mobility After Revascularization in Peripheral Artery Disease
Peripheral Artery Disease, Intermittent Claudication
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Passive Calf Stretching Therapy in Peripheral Artery Disease
Peripheral Artery Disease, Claudication, Intermittent
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.
Anne-Mette H Momsen, MPH, Phys, ph.D stud principal investigator
Herning Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Caffeine 6mg/kg in people with Intermittent Claudication, run by University of Aarhus 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 3 inclusion and 7 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 9 Jun 2011. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Quality of life (time frame: during test 1 and 3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00388128, which also lists 1 linked publication.
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 9 Jun 2011.