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Caffeine and Intermittent Claudication

NCT00388128 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2011-06-09

No results posted yet for this study

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).

Conditions

  • Intermittent Claudication

Interventions

DRUG

Caffeine 6mg/kg

Capsules of caffeine 6 mg/kg, taken orally at each test. Before and after treadmill testing

Sponsors & Collaborators

  • Herning Hospital

    collaborator OTHER

  • Central Jutland Regional Hospital

    collaborator OTHER

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Anne-Mette H Momsen, MPH, Phys, ph.D stud · Herning Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2009-05-31
Completion
2009-09-30

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00388128 on ClinicalTrials.gov