Exercise Therapy in Patients With Peripheral Artery Disease: Evaluating the Clinical Effectiveness of Exercise Therapy and Exploring Determinants of Improvement (PROSECO)

Catholic University (KU) of Leuven

Status

Completed

Conditions

Peripheral Arterial Disease

Treatments

Other: Walking

Other: Control

Study type

Interventional

Funder types

Other

Identifiers

NCT03995589

s9acq68z

Details and patient eligibility

About

I. To investigate whether patient characteristics, exercise therapy characteristics, local metabolic exercise response, endothelial function, autonomic function or atherosclerotic lesion location can predict the walking response to a successfully completed semi-supervised exercise intervention in patients with intermittent claudication (WP I) II. To assess the effect of a home-based exercise intervention with remote monitoring and coaching on cardiovascular risk factors in patients with intermittent claudication (WP II)

Enrollment

59 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

The study population will comprise patients diagnosed with lower-extremity artery disease (ABI ≤0.9 and/or 20% decrease after a maximal treadmill test) suffering from intermittent claudication (Rutherford 1-3) presenting with new complaints (at least 6 months after previous revascularization) at the Vascular Center of university hospitals Leuven will be included if according to current guidelines their initial treatment should be conservative

Inclusion Criteria:

age > 17 yrs
ABI ≤0.9 and/or 20% decrease after a maximal treadmill test
intermittent claudication (Rutherford 1-3)
ability to undertake an exercise test and read and understand Dutch questionnaires

Exclusion criteria

exercise test induced signs of complex arrhythmias or significant ischemia during baseline testing
other comorbidity limiting participation in the exercise group