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NCT03995589 Clinical Trial

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

Peripheral Arterial Disease Clinical Trial

— PROSECO  

Official title:
Exercise Therapy in Patients With Peripheral Artery Disease: Evaluating the Clinical Effectiveness of Exercise Therapy and Exploring Determinants of Improvement

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03995589
Other study ID # s9acq68z
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2019
Est. completion date March 1, 2021

Study information
Verified date March 2022
Source KU Leuven
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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)

Recruitment information / eligibility
Status Completed
Enrollment 59
Est. completion date March 1, 2021
Est. primary completion date March 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Walking
Technology-guided semi-supervised walking therapy
• Control
Go Home and Walk advice

Locations
Country Name City State
Belgium KU Leuven Leuven

Sponsors (1)
Lead Sponsor Collaborator
KU Leuven

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pain free walking distance Treadmill protocol Baseline - 12 weeks
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