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出境医 / 临床实验 / Exercise Therapy in Patients With Peripheral Artery Disease: Evaluating the Clinical Effectiveness of Exercise Therapy and Exploring Determinants of Improvement (PROSECO)

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

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)

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

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 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 : May 2021
Estimated Study Completion Date : May 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: Walking Group Other: Walking
Technology-guided semi-supervised walking therapy
Active Comparator: Control Other: Control
Go Home and Walk advice
Outcome Measures
Primary Outcome Measures :
  1. Pain free walking distance [ Time Frame: Baseline - 12 weeks ]
    Treadmill protocol


Eligibility Criteria
Layout table for eligibility information
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
Contacts and Locations

Locations
Layout table for location information
Belgium
KU Leuven
Leuven, Belgium, 3000
Sponsors and Collaborators
KU Leuven
Tracking Information
First Submitted Date  ICMJE June 20, 2019
First Posted Date  ICMJE June 24, 2019
Last Update Posted Date February 5, 2021
Actual Study Start Date  ICMJE March 1, 2019
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 20, 2019) 		Pain free walking distance [ Time Frame: Baseline - 12 weeks ]
Treadmill protocol
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exercise Therapy in Patients With Peripheral Artery Disease: Evaluating the Clinical Effectiveness of Exercise Therapy and Exploring Determinants of Improvement
Official Title  ICMJE Exercise Therapy in Patients With Peripheral Artery Disease: Evaluating the Clinical Effectiveness of Exercise Therapy and Exploring Determinants of Improvement
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)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Peripheral Arterial Disease
Intervention  ICMJE
  • Other: Walking
    Technology-guided semi-supervised walking therapy
  • Other: Control
    Go Home and Walk advice
Study Arms  ICMJE
  • Experimental: Walking Group
    Intervention: Other: Walking
  • Active Comparator: Control
    Intervention: Other: Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: February 4, 2021) 		59
Original Estimated Enrollment  ICMJE
 (submitted: June 20, 2019) 		100
Estimated Study Completion Date  ICMJE May 2021
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03995589
Other Study ID Numbers  ICMJE s9acq68z
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Véronique Cornelissen, KU Leuven
Study Sponsor  ICMJE KU Leuven
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account KU Leuven
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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