Caffeine and Intermittent Claudication

June 8, 2011 updated by: University of Aarhus

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Region Central-Jutland
      • Herning, Region Central-Jutland, Denmark, 7400
        • Herning Hospital, Surgical research dep.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quality of life
Time Frame: during test 1 and 3
during test 1 and 3
Maximum walking distance
Time Frame: during treadmill test
during treadmill test

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Herning Hospital
Central Jutland Regional Hospital

Investigators

  • Principal Investigator: Anne-Mette H Momsen, MPH, Phys, ph.D stud, Herning Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

October 12, 2006

First Submitted That Met QC Criteria

October 12, 2006

First Posted (Estimate)

October 13, 2006

Study Record Updates

Last Update Posted (Estimate)

June 9, 2011

Last Update Submitted That Met QC Criteria

June 8, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006-001902-10
  • 2006/168

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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