Lower Extremity Peripheral Arterial Disease and Exercise Ischemia (CLASH)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief 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.

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.

Condition or disease	Intervention/treatment	Phase
Peripheral Arterial Diseases; Intermittent Claudication	Other: Subsequent walking performance	Not Applicable

Detailed Description:

Primary Outcome Measure :

Coefficient of determination between the recovery duration and subsequent walking performance, obtained from individual regression analyses.

Secondary outcome measures :

1. Coefficient of determination determined from different curves fitting.
2. Coefficient of correlation between the level of ischemia during recovery and exercise ischemia and pain occurrence during subsequent walking.
3. Coefficient of correlation between the optimal recovery duration measured on the laboratory and measures from community-based measurements.

Eligibility criteria :

Inclusion criteria :

• Age > 18 years.
• Ankle-to-Brachial index ≤ 0.90 ;
• Patient with symptom of intermittent claudication
• Maximal walking distance on treadmill < 500 m (treadmill protocol 3.2 km/h, 10% grade) ;
• Informed consent obtained

Exclusion criteria :

• Patients that do not understand the protocol and the recommendations of the study;
• Patients living far away from the university hospital (more than 50 km)
• Diabetic patients;
• Medical therapy for chronic management of pain;
• Contraindication(s) for walking;
• Patient with critical ischemia;
• Exercise limitations others than vascular reasons.
• Cardiovascular events within the three months before inclusion ;
• Pregnant women;
• Adults subject to legal protection.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	40 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Supportive Care
Official Title:	Lower Extremity Peripheral Arterial Disease and Exercise Ischemia: Walking Capacity Variability, Pain Evolution and Pathophysiological Responses. The CLASH Study.
Study Start Date :	September 2014
Estimated Primary Completion Date :	July 2019
Estimated Study Completion Date :	October 2019

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Subsequent walking performance; Subsequent walking performance	Other: Subsequent walking performance; Subsequent walking performance

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. Coefficient of determination determined from different curves fitting [ Time Frame: 32 days ]
   Coefficient of determination determined from different curves fitting

Other Outcome Measures:

1. 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
2. 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

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Age > 18 years.
• Ankle-to-Brachial index ≤ 0.90 ;
• Patient with symptom of intermittent claudication
• Maximal walking distance on treadmill < 500 m (treadmill protocol 3.2 km/h, 10% grade) ;
• Informed consent obtained

Exclusion Criteria:

• Patients that do not understand the protocol and the recommendations of the study;
• Patients living far away from the university hospital (more than 50 km)
• Diabetic patients;
• Medical therapy for chronic management of pain;
• Contraindication(s) for walking;
• Patient with critical ischemia;
• Exercise limitations others than vascular reasons.
• Cardiovascular events within the three months before inclusion ;
• Pregnant women;
• Adults subject to legal protection.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Guillaume MAHE, MD	+33 (0)2.99.28.43.09	guillaume.mahe@chu-rennes.fr
Contact: Alexis Le Faucheur	+33 (0)2.99.05.94.19	alexis.lefaucheur@bretagne.ens-cachan.fr

Locations

France
Rennes University Hospital	Recruiting
Rennes, Brittany, France, 35033
Contact: Guillaume MAHE, MD
Principal Investigator: Guillaume MAHE, MD
Sub-Investigator: Antoine LUCAS, MD
Sub-Investigator: Alain CARDON, MD

Sponsors and Collaborators

Rennes University Hospital

Investigators

Principal Investigator:	Guillaume MAHE, MD	Rennes University Hospital

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Rennes University Hospital
ClinicalTrials.gov Identifier:	NCT02041169 History of Changes
Other Study ID Numbers:	35RC13-9907-CLASH; 2013-A01381-44 ( Other Identifier: ANSM ); 13/34-914 ( Other Identifier: CPP Ouest V )
First Posted:	January 20, 2014
Last Update Posted:	April 9, 2018
Last Verified:	April 2018

Additional relevant MeSH terms:

Intermittent Claudication; Ischemia; Peripheral Arterial Disease; Peripheral Vascular Diseases; Pathologic Processes; Atherosclerosis	Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms