Lower Extremity Peripheral Arterial Disease and Exercise Ischemia: Walking Capacity Variability, Pain Evolution and Pathophysiological Responses. The CLASH Study.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Peripheral Arterial Diseases
- Sponsor
- Rennes University Hospital
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- Coefficient of determination between the recovery duration and subsequent walking performance, obtained from individual regression analyses.
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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 :
- To determine the nature of the relationship between the recovery duration and subsequent walking performance.
- To study the relationship between exercise ischemia, pain evolution and previous recovery duration.
- To determine whether the experimental procedure influence the determination of an optimal of minimal recovery duration.
- To study the influence of recovery duration on walking capacity from community-based measurement.
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.
Investigators
Eligibility Criteria
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)
- •As assessed during the medical appointment.
- •According to our inclusion criteria, patients' leg symptoms that fell within the following leg symptom categories could be included in the study:
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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 Outcomes
- Coefficient of determination determined from different curves fitting(32 days)