Effects of Caffeine in Patients With Intermittent Claudication.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Maximum walking distance
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
A
干预措施: Caffeine 6mg/kg (Drug)
结局指标
主要结局
Maximum walking distance
时间窗: during treadmill test
Quality of life
时间窗: during test 1 and 3
次要结局
- Painfree Walking Distance(treadmill test)
- Max muscle strength (MVC) of kneeextension(At end of each test)
- Endurance of 50%MVC kneeextension(At end of each test)
- Postural stability(in all tests)
- Reaction speed(in all tests)
- Cognitive function(in all tests)
- Walking Impairment Questionnaire(in first and third test)
- vascular endothelian growth factors VGF. FGF(before and after 1. and 2. test)