Intermittent Claudication, Peripheral Arterial Disease
Conditions
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.
Interventions
DEVICEtranscutaneous electrical calf muscle stimulation + supervised walking therapy
transcutaneous electrical calf muscle stimulation + supervised walking therapy
Sponsors
Heinrich-Heine University, Duesseldorf
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* intermittent claudication due to peripheral arterial disease * ankle brachial index \</=0.9 * occlusion or stenosis of the superficial femoral artery
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Walking distance | 6 months | Measurement of the pain-free and absolute walking distance on a standardized constant load treadmill test |
Countries
Germany
Contacts
Primary ContactPhilip Düppers, MD
Outcome results
None listed