Rennes University Hospital
Rennes, Brittany Region, 35033, France
NCT Number: NCT02041169
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Rennes, Brittany Region, 35033, France
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 :
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
Subsequent walking performance
Time frame: 32 days
Coefficient of determination between the recovery duration and subsequent walking performance, obtained from individual regression analyses.
Time frame: 32 days
Coefficient of determination determined from different curves fitting
Time frame: 32 days
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 optimal recovery duration measured on the laboratory and measures from community-based measurements
Rennes University Hospital
Other
Lower Extremity Peripheral Arterial Disease and Exercise Ischemia: Walking Capacity Variability, Pain Evolution and Pathophysiological Responses. The CLASH Study.
Acronym: CLASH
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