Transcutaneous Electrostimulation of the Calf Muscle and Supervised Walking Therapy for Intermittent cLAudication
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Walking distance
研究概览
简要总结
Prospective mono-centric trial on patients with peripheral arterial disease and intermittent claudication that receive supervised exercise therapy (group 1) vs. supervised exercise therapy + daily transcutaneous electro-stimulation of the calf muscles.
详细描述
The investigators conduct a prospective mono-centric trial on all patient with peripheral arterial disease with intermittent claudication that receive supervised exercise therapy (SET) and additional transcutaneous electric stimulation (TES) of the calf muscle. SET program consists in once weekly walking training for 75 min under supervision of a professional trainer. Patients are encouraged to continue the training modules at home. TES is performed using the mobile "Veinoplus arterial" device (AdRem Technology, France) on a daily base for 60-120 min at home. Patient outcome will be compared to the retrospectively analyzed results of patients, that received the same SET program alone in the past.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •intermittent claudication due to peripheral arterial disease
- •ankle brachial index </=0.9
- •occlusion or stenosis of the superficial femoral artery
排除标准
- •rest pain or peripheral arterial lesions
- •contraindications for supervised walking therapy
- •non-vascular conditions that limit patients´ walking ability
- •patients that have already received supervised walking therapy
- •occlusion of the deep femoral artery
- •occlusion or high-grade stenoses of the iliac arteries
- •stroke in the last 12 months
- •premenopausal women
- •diabetes mellitus, dialysis, sclerodermia and other conditions that impair leg perfusion
- •active cilostazol therapy or alprostadil-infusion in the last 3 months
- •pacemaker, defibrillator systems, life vest
- •visible muscle contraction is not achieved without pain
结局指标
主要结局
Walking distance
时间窗: 6 months
Measurement of the pain-free and absolute walking distance on a standardized constant load treadmill test
次要结局
未报告次要终点
研究者
Dr. Philip Düppers
Dr. med.
Heinrich-Heine University, Duesseldorf