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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03995589
Recruitment Status : Recruiting
First Posted : June 24, 2019
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
Véronique Cornelissen, KU Leuven

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)

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Other: Walking Other: Control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exercise Therapy in Patients With Peripheral Artery Disease: Evaluating the Clinical Effectiveness of Exercise Therapy and Exploring Determinants of Improvement
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Walking Group Other: Walking
Technology-guided semi-supervised walking therapy

Active Comparator: Control Other: Control
Go Home and Walk advice




Primary Outcome Measures :
  1. Pain free walking distance [ Time Frame: Baseline - 12 weeks ]
    Treadmill protocol



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03995589


Contacts
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Contact: Véronique Cornelissen, PhD 016329152 veronique.cornelissen@kuleuven.be

Locations
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Belgium
KU Leuven Recruiting
Leuven, Belgium, 3000
Contact: Veronique Cornelissen, PhD    003216329152    veronique.cornelissen@faber.kuleuven.be   
Sponsors and Collaborators
KU Leuven
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Responsible Party: Véronique Cornelissen, Assistant Professor, KU Leuven
ClinicalTrials.gov Identifier: NCT03995589    
Other Study ID Numbers: s9acq68z
First Posted: June 24, 2019    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases