Lower Extremity Peripheral Arterial Disease and Exercise Ischemia (CLASH)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2014 by Rennes University Hospital
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT02041169
First received: January 14, 2014
Last updated: August 5, 2014
Last verified: August 2014
  Purpose

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 Intervention
Peripheral Arterial Diseases
Intermittent Claudication
Other: Subsequent walking performance

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Rennes University Hospital:

Primary Outcome Measures:
  • Coefficient of determination between the recovery duration and subsequent walking performance, obtained from individual regression analyses. [ Time Frame: 32 days ] [ Designated as safety issue: No ]
    Coefficient of determination between the recovery duration and subsequent walking performance, obtained from individual regression analyses.


Secondary Outcome Measures:
  • Coefficient of determination determined from different curves fitting [ Time Frame: 32 days ] [ Designated as safety issue: No ]
    Coefficient of determination determined from different curves fitting


Other Outcome Measures:
  • Coefficient of correlation between the level of ischemia during recovery and exercise ischemia and pain occurrence during subsequent walking [ Time Frame: 32 days ] [ Designated as safety issue: No ]
    Coefficient of correlation between the level of ischemia during recovery and exercise ischemia and pain occurrence during subsequent walking

  • Coefficient of correlation between the optimal recovery duration measured on the laboratory and measures from community-based measurements. [ Time Frame: 32 days ] [ Designated as safety issue: No ]
    Coefficient of correlation between the optimal recovery duration measured on the laboratory and measures from community-based measurements


Estimated Enrollment: 40
Study Start Date: September 2014
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Subsequent walking performance
    Subsequent walking performance
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02041169

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 Not yet 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

No publications provided

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT02041169     History of Changes
Other Study ID Numbers: 35RC13-9907-CLASH, 2013-A01381-44, 13/34-914
Study First Received: January 14, 2014
Last Updated: August 5, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Additional relevant MeSH terms:
Intermittent Claudication
Ischemia
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms
Pathologic Processes
Atherosclerosis

ClinicalTrials.gov processed this record on August 28, 2014