Exercise Therapy in Patients With Peripheral Artery Disease: Evaluating the Clinical Effectiveness of Exercise Therapy and Exploring Determinants of Improvement
PROSECO
1 other identifier
interventional
59
1 country
1
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2019
CompletedFirst Submitted
Initial submission to the registry
June 20, 2019
CompletedFirst Posted
Study publicly available on registry
June 24, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2021
CompletedMarch 8, 2022
March 1, 2022
2 years
June 20, 2019
March 7, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Pain free walking distance
Treadmill protocol
Baseline - 12 weeks
Study Arms (2)
Walking Group
EXPERIMENTALControl
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- exercise test induced signs of complex arrhythmias or significant ischemia during baseline testing
- other comorbidity limiting participation in the exercise group
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- KU Leuvenlead
Study Sites (1)
KU Leuven
Leuven, 3000, Belgium
Related Publications (1)
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.
PMID: 34417620DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
June 20, 2019
First Posted
June 24, 2019
Study Start
March 1, 2019
Primary Completion
March 1, 2021
Study Completion
March 1, 2021
Last Updated
March 8, 2022
Record last verified: 2022-03