Caffeine and Intermittent Claudication

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Aarhus
• Collaborators: Central Jutland Regional Hospital; Herning Hospital
• Treatments: Caffeine

Criteria

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