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Caffeine and Intermittent Claudication

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. Identifier: NCT00388128
Recruitment Status : Completed
First Posted : October 13, 2006
Last Update Posted : June 9, 2011
Herning Hospital
Central Jutland Regional Hospital
Information provided by:
University of Aarhus

Brief 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. 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).

Condition or disease Intervention/treatment Phase
Intermittent Claudication Drug: Caffeine 6mg/kg Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Caffeine in Patients With Intermittent Claudication.
Study Start Date : September 2006
Actual Primary Completion Date : May 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caffeine

Arm Intervention/treatment
Placebo Comparator: A Drug: Caffeine 6mg/kg
Capsules of caffeine 6 mg/kg, taken orally at each test. Before and after treadmill testing

Primary Outcome Measures :
  1. Quality of life [ Time Frame: during test 1 and 3 ]
  2. Maximum walking distance [ Time Frame: during treadmill test ]

Secondary Outcome Measures :
  1. Painfree Walking Distance [ Time Frame: treadmill test ]
  2. Max muscle strength (MVC) of kneeextension [ Time Frame: At end of each test ]
  3. Endurance of 50%MVC kneeextension [ Time Frame: At end of each test ]
  4. Postural stability [ Time Frame: in all tests ]
  5. Reaction speed [ Time Frame: in all tests ]
  6. Cognitive function [ Time Frame: in all tests ]
  7. Walking Impairment Questionnaire [ Time Frame: in first and third test ]
  8. vascular endothelian growth factors VGF. FGF [ Time Frame: before and after 1. and 2. test ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00388128

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Herning Hospital, Surgical research dep.
Herning, Region Central-Jutland, Denmark, 7400
Sponsors and Collaborators
University of Aarhus
Herning Hospital
Central Jutland Regional Hospital
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Principal Investigator: Anne-Mette H Momsen, MPH, Phys, ph.D stud Herning Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Regional Hospital Herning, Surgical Research Unit Identifier: NCT00388128    
Other Study ID Numbers: 2006-001902-10
First Posted: October 13, 2006    Key Record Dates
Last Update Posted: June 9, 2011
Last Verified: June 2011
Keywords provided by University of Aarhus:
Intermittent Claudication
Walking capacity
Growth factor
Additional relevant MeSH terms:
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Intermittent Claudication
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents