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. Interventions designed to improve walking impairment may have a significant impact on the functional capacity in LEPAD patients. Lower extremity electrical stimulation is an older technique that relies on different types of electrical stimulations with different expected physiological effects on hemodynamics, skeletal muscle functions or pain pathway. The aim of the ELECTRO-PAD study is to assess the effect of a 12 weeks program of neuromuscular electrical stimulation (NMES) on the absolute walking distance (AWD) measured during a treadmill test in peripheral artery disease patients.
The aim of the ELECTRO-PAD study is to assess the effect of a 12 weeks program of neuromuscular electrical stimulation (NMES) on the absolute walking distance (AWD) measured during a treadmill test in peripheral artery disease patients. Arteriopatic patients will be randomized in 2 groups : * patients submitted to a 12 weeks program of neuromuscular electrical stimulation (NMES group) * patients without any program (control group) All patients will also receive a study participation guide that will include an information leaflet outlining tips for active living and walking. After eligibility criteria will be assessed, patient will be included and randomized (visit 1). A second visit will be performed after 12 weeks (visit 2). In parallel, 2 ancillary studies will be performed : * Among Rennes' arteriopatic patients, endothelial function will be assessed using measures from 40 patients. Assessment will be done between 1 and 14 days after visit 1 (visit 1') * The second ancillary study concerns 40 volunteers with no cardiac or vascular pathology, only in the coordinating center Rennes. The same measures will be performed for these volunteers and for arteriopatic patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
120
A 12-week program of neuromuscular electrical stimulation
A 12-week program of walking sessions performed outdoors and independently
The usual practice associated with an information leaflet outlining tips for active living and walking.
CHU Angers
Angers, France
CHU Brest
Brest, France
CHU Caen
Caen, France
CHU de Rennes
Rennes, France
Hôpital de Rangueil
Toulouse, France
Change in treadmill walking distance to maximal leg pain (absolute walking distance)
Comparison of change in treadmill walking distance to maximal leg pain (absolute walking distance) after 12 weeks between ESM group and control group (between visit 1 and visit 2)
Time frame: 12 weeks
Change in treadmill walking distance to onset of leg pain
Comparison of change in treadmill walking distance to onset of leg pain between visit 1 and visit 2, and between NMES and control group
Time frame: 12 weeks
Change in 6-minute total walk distance
Comparison of change in 6-minute total walk distance between visit 1 and visit 2, and between NMES and control group
Time frame: 12 weeks
Change in maximal walking distance and medium walking speed under natural outdoor conditions
Comparison of change in maximal walking distance and medium walking speed under natural outdoor conditions between visit 1 and visit 2, and between NMES and control group
Time frame: 12 weeks
Change in the Walking Impairment Questionnaire score
Comparison of change in the Walking Impairment Questionnaire (WIQ) score between visit 1 and visit 2 and between NMES and control group. the WIQ is a valid tool to detect improvement or deterioration in the daily walking ability of patients with intermittent claudication. The higher the WIQ score is, the better the patient's functional walking ability is.
Time frame: 12 weeks
Change in the Short Form (36) Health Survey (SF36) score
Comparison of change in the Short Form (36) Health Survey (SF36) score between visit 1 and visit 2, and between NMES and control group. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. To calculate the scores it is necessary to purchase special software.
Time frame: 12 weeks
Change in the Peripheral Artery Questionnaire (PAQ) score
Comparison of change in the Peripheral Artery Questionnaire score between visit 1 and visit 2, and between NMES and control group. The Peripheral Artery Questionnaire (PAQ) is a 20-item questionnaire developed to meet this need by quantifying patients' physical limitations, symptoms, social function, treatment satisfaction, and quality of life. higher scores represent fewer symptoms and better health status
Time frame: 12 weeks
Change in in actigraphy measures
Comparison of change in actigraphy measures to define daily physical activity level between visit 1 and visit 2 and between NMES, and control group
Time frame: 12 weeks
Change in ankle brachial index
Comparison of change in ankle brachial index between visit 1 and visit 2, and between NMES and control group. The ankle-brachial index (ABI) is the ratio of the blood pressure at the ankle to the blood pressure in the upper arm (brachium). Compared to the arm, lower blood pressure in the leg suggests blocked arteries due to peripheral artery disease (PAD). The ABI is calculated by dividing the systolic blood pressure at the ankle by the systolic blood pressure in the arm
Time frame: 12 weeks
Change in TcPO2 DROP during treadmill walking test
Comparison of change in TcPO2 DROP during treadmill walking test between visit 1 and visit 2 and between NMES and control group
Time frame: 12 weeks
Number of patients submitted to a revascularization procedure
Comparison in the number of patients submitted to a revascularization procedure between visit 1 and visit 2, and between NMES and control group
Time frame: 12 weeks
Change in results of Contrast imaging with laser granularity
Comparison of change in endothelial function using Contrast imaging with laser granularity, only for arteriopathic patients included in Rennes, between visit 1 and visit 2 and between NMES and control group. Laser Contrast Granularity Analysis is a method that allows the visualization of tissue blood perfusion instantly in real time.
Time frame: 12 weeks
Percentage of physiological response achieved by patients
Percentage of physiological response achieved by patients for all outcome measures (comparison with parameters of volunteers without any cardiac or vascular disease) between all visits
Time frame: 12 weeks
Change in maximum walking distance according to the location of the arterial obstruction
Change in maximum walking distance according to the location of the arterial obstruction using scan images between visit 1 and visit 2 and between NMES and control group.
Time frame: 12 weeks
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