Lower Extremity Peripheral Arterial Disease and Exercise Ischemia — CLASH  

Intermittent Claudication Clinical Trial

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

Status Completed

Clinical Trial Summary

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Intermittent Claudication
• Ischemia
• Peripheral Arterial Disease
• Peripheral Arterial Diseases
• Peripheral Vascular Diseases

• NCT number: NCT02041169
• Study type: Interventional
• Source: Rennes University Hospital
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Completion date: September 2018