Status:
COMPLETED
Structured Home-based Exercise Versus Walking Advice in Claudication Patients: a Randomized-controlled Trial
Lead Sponsor:
University Hospital of Ferrara
Conditions:
Peripheral Artery Disease
Eligibility:
All Genders
60+ years
Phase:
NA
Brief Summary
A recent position paper calls for effective home-based exercise program for patients with peripheral artery disease (PAD) and claudication to be implemented in real-world care. This randomized-contro...
Eligibility Criteria
Inclusion
- male and females aged \> 60 years old
- peripheral artery disease at Leriche-Fontaine's stage 2a or 2b
- cognitive functioning to give informed consent identified by a Mini Mental Status Examination score ≥18/30.
Exclusion
- peripheral artery disease at Leriche-Fontaine's stage 1
- peripheral artery disease at Leriche-Fontaine's stage 3 or more
- severe cardio-respiratory conditions (e.g. unstable angina; severe heart failure identified by New York Heart Association class III or IV)
- neurological or musculoskeletal conditions (e.g. above knee amputation) contraindicating or inhibiting exercise training.
- very good exercise capacity determined by a 6-minute walking distance \> 500 meters.
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT04751890
Start Date
March 1 2021
End Date
December 31 2023
Last Update
August 11 2025
Active Locations (1)
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1
University Hospital of Ferrara
Ferrara, Italy, 44124