Transcutaneous Electrostimulation for Intermittent Claudication Supervised Walking Therapy for Intermittent cLAudication
- Conditions
- Intermittent ClaudicationPeripheral Arterial Disease
- Registration Number
- NCT03512912
- Lead Sponsor
- Heinrich-Heine University, Duesseldorf
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
- intermittent claudication due to peripheral arterial disease
- ankle brachial index </=0.9
- occlusion or stenosis of the superficial femoral artery
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Walking distance 6 months Measurement of the pain-free and absolute walking distance on a standardized constant load treadmill test
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University Hospital Dusseldorf, Department of Vascular and Endovascular Surgery
🇩🇪Dusseldorf, NRW, Germany