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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03995589
Acronym
PROSECO
Enrollment
59
Registered
2019-06-24
Start date
2019-03-01
Completion date
2021-03-01
Last updated
2022-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Arterial Disease

Brief 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)

Interventions

OTHERWalking

Technology-guided semi-supervised walking therapy

OTHERControl

Go Home and Walk advice

Sponsors

KU Leuven
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Pain free walking distanceBaseline - 12 weeksTreadmill protocol

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026