Lower Extremity Peripheral Arterial Disease and Exercise Ischemia (CLASH)

May 22, 2023 updated by: Rennes University Hospital

Lower Extremity Peripheral Arterial Disease and Exercise Ischemia: Walking Capacity Variability, Pain Evolution and Pathophysiological Responses. The CLASH Study.

Lower extremity peripheral arterial disease (LEPAD) is a highly prevalent chronic disease. Cardiovascular mortality of LEPAD patients at five years ranges between 18 to 30%. LEPAD is primarily caused by atherosclerosis that induces an inadequate blood flow to meet the tissues demand due to the narrowing of the arteries. An aggravation of the arterial lesions in LEPAD patients induces a worsening of patients' symptoms and a severe limitation of their walking capacity, contributing to an impairment of their quality of life. Despite maintaining a sufficient walking activity is essential for these patients, LEPAD patients lower their physical activity, which worsen the disease and potentially contribute to increase the risk of cardiovascular events and deaths.

In a recent study in LEPAD patients, we showed, from a one hour GPS recording, a high variability of the patients' walking capacity (i.e., walking distances between two stops induced by lower limbs pain). Results suggested that in most patients previous stop duration before each walk was a predictor parameter of this walking variability. Whether there is an optimal or minimal recovery time influencing the walking capacity in LEPAD patients has never been studied.

This study is a prospective, cross-sectional study in exercise pathophysiology.

The main goal is to determine, following a walk that induces ischemia, the influence of the recovery duration on the subsequent walking performance in LEPAD patients.

Secondary goals are :

  1. To determine the nature of the relationship between the recovery duration and subsequent walking performance.
  2. To study the relationship between exercise ischemia, pain evolution and previous recovery duration.
  3. To determine whether the experimental procedure influence the determination of an optimal of minimal recovery duration.
  4. To study the influence of recovery duration on walking capacity from community-based measurement.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

It is expected to determine for the first time an optimal recovery duration that would maximize the walking capacity of LEPAD patients.

In the medium term :

  • To give indications to the LEPAD patients to manage their pain in the community without lower their physical activity.
  • To limit the functional decline of LEPAD patients.
  • To influence the quality of life and cardiovascular mortality. This would deserve furthers studies.

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Brittany
      • Rennes, Brittany, France, 35033
        • Rennes University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 18 years old
  • Insured under the French social security system (according to French law)

  • Presence of lower-extremity peripheral artery disease, defined by:

    • A resting ankle-brachial index (ABI) ≤ 0.90
    • OR if resting ABI > 0.90 and < 1.00, a decrease in recovery ankle systolic pressure or in recovery ABI from treadmill exercise higher than 30% or 20%, respectively (AHA recommendations).
    • OR if resting ABI > 1.40, a toe pressure index ≤ 0.70
  • Maximal walking distance on treadmill (3.2 km/h, 10% grade) < 500m (a)

  • Complain of exertional lower limbs pain that can begin or not at rest, causes the participant to stop walking and relieves or lessens within 10 minutes of rest (assessed using the San Diego questionnaire AND confirmed during treadmill testing) (b)

    1. As assessed during the medical appointment.
    2. According to our inclusion criteria, patients' leg symptoms that fell within the following leg symptom categories could be included in the study:

    i) Intermittent claudication. Patients that experience exertional calf pain that does not begin at rest and that forces them to stop walking and that relieves or lessens within 10 minutes of rest; ii) Atypical exertional leg pain/stop. This category can encompass diverse situations of exertional leg symptoms. In the present study, patients in this category were included if they experience exertional pain that does not begin at rest and that forces them to stop walking, but that do not involve only the calf(s) but also thigh(s) and/or buttock(s). Further, the exertional leg pain relieves or lessens within 10 minutes of rest; iii) Leg pain on exertion and rest. In this category, patients sometimes experience exertional leg pain at rest when they are standing still or sitting. On exertion, patients also experience a walking pain as described above. As reminded by Criqui et al., this category of patients with "pain at rest" should not be confused with patients that experience "rest pain", which usually refers to patients with such severe advanced PAD that ischemic pain is present even at rest. Patients with ischemic rest pain were not included in the study.

Non-Inclusion criteria

  • Exercise limitation due to symptoms not related to an arterial insufficiency in the lower limbs (e.g., dyspnea, angina pectoris)
  • Contraindication for walking (Abdominal aortic aneurysm > 4 cm)
  • Myocardial infarction and no stroke in the last 3 months
  • Critical limb ischemia, amputation.
  • Pregnant women
  • Adult subject to legal protection (guardianship or tutelage measure) and persons deprived from their liberty (according to French law).
  • Patient living more than 50 km from the university hospital
  • Patient unable to understand the instructions of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Subsequent walking performance
Other: Subsequent walking performance
Subsequent walking performance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Coefficient of determination between the recovery duration and subsequent walking performance, obtained from individual regression analyses.
Time Frame: 32 days
Coefficient of determination between the recovery duration and subsequent walking performance, obtained from individual regression analyses.
32 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Coefficient of determination determined from different curves fitting
Time Frame: 32 days
Coefficient of determination determined from different curves fitting
32 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Coefficient of correlation between the level of ischemia during recovery and exercise ischemia and pain occurrence during subsequent walking
Time Frame: 32 days
Coefficient of correlation between the level of ischemia during recovery and exercise ischemia and pain occurrence during subsequent walking
32 days
Coefficient of correlation between the optimal recovery duration measured on the laboratory and measures from community-based measurements.
Time Frame: 32 days
Coefficient of correlation between the optimal recovery duration measured on the laboratory and measures from community-based measurements
32 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Investigators

  • Principal Investigator: Guillaume MAHE, MD, Rennes University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2014

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

September 1, 2018

Study Registration Dates

First Submitted

January 14, 2014

First Submitted That Met QC Criteria

January 17, 2014

First Posted (Estimate)

January 20, 2014

Study Record Updates

Last Update Posted (Actual)

May 24, 2023

Last Update Submitted That Met QC Criteria

May 22, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 35RC13-9907-CLASH
  • 2013-A01381-44 (Other Identifier: ANSM)
  • 13/34-914 (Other Identifier: CPP Ouest V)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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