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Clinical Trials/NCT03995589
NCT03995589
Completed
Not Applicable

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

KU Leuven1 site in 1 country59 target enrollmentMarch 1, 2019
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ConditionsPeripheral Arterial Disease

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Peripheral Arterial Disease
Sponsor
KU Leuven
Enrollment
59
Locations
1
Primary Endpoint
Pain free walking distance
Status
Completed
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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)

Registry
clinicaltrials.gov
Start Date
March 1, 2019
End Date
March 1, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
KU Leuven
Responsible Party
Principal Investigator
Principal Investigator

Véronique Cornelissen

Assistant Professor

KU Leuven

Eligibility Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Pain free walking distance

Time Frame: Baseline - 12 weeks

Treadmill protocol

Study Sites (1)

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