Back to resultsExercise Therapy in Patients With Peripheral Artery Disease: Evaluating the Clinical Effectiveness of Exercise Therapy and Exploring Determinants of Improvement (PROSECO)
Primary Purpose
Peripheral Arterial Disease
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Walking
Control
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Arterial Disease
Eligibility 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
Sites / Locations
- KU Leuven
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Walking Group
Control
Arm Description
Outcomes
Primary Outcome Measures
Pain free walking distance
Treadmill protocol
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03995589
Brief Title
Exercise Therapy in Patients With Peripheral Artery Disease: Evaluating the Clinical Effectiveness of Exercise Therapy and Exploring Determinants of Improvement
Acronym
PROSECO
Official Title
Exercise Therapy in Patients With Peripheral Artery Disease: Evaluating the Clinical Effectiveness of Exercise Therapy and Exploring Determinants of Improvement
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
March 1, 2021 (Actual)
Study Completion Date
March 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
KU Leuven
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Walking Group
Arm Type
Experimental
Arm Title
Control
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Walking
Intervention Description
Technology-guided semi-supervised walking therapy
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Go Home and Walk advice
Primary Outcome Measure Information:
Title
Pain free walking distance
Description
Treadmill protocol
Time Frame
Baseline - 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
KU Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34417620
Citation
Cornelis N, Buys R, Fourneau I, Van den Bosch A, De Wilde C, Goetschalckx K, Cornelissen V. Cardiorespiratory fitness in patients with lower extremity artery disease? It takes more than just some steps! Eur J Prev Cardiol. 2022 May 5;29(5):e190-e192. doi: 10.1093/eurjpc/zwab135. No abstract available.
Results Reference
derived
Learn more about this trial
Exercise Therapy in Patients With Peripheral Artery Disease: Evaluating the Clinical Effectiveness of Exercise Therapy and Exploring Determinants of Improvement
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