Status:
COMPLETED
Effect of a Neuromuscular Electrical Stimulation Program on Walking Capacity in Peripheral Artery Disease Patients
Lead Sponsor:
Rennes University Hospital
Collaborating Sponsors:
AD REM TECHNOLOGY
Ecole Normale Supérieure de Rennes
Conditions:
Arteriopathy
Eligibility:
All Genders
41+ years
Phase:
NA
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 ...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Arteriopatic patients :
- Age \> 40 years old.
- Subjects with Lower Extremity Peripheral Artery disease (LEPAD). LEPAD is defined by the presence of at least one of the following criteria:
- History of revascularization in the lower limbs due to LEPAD; OR
- Ankle brachial index (ABI) of ≤ 0.90; OR
- ABI or ankle systolic blood pressure decrease during recovery from treadmill walking test \> 20 % or \> 30 mmHg, respectively; OR
- Toe-brachial index ≤0.70 if ABI cannot be measured and if incompressible arteries are suspected.
- Complain of exertional calf pain (fatigue, discomfort or cramping) 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);
- Pain (fatigue, discomfort or cramping) is mainly located at the calves' level.
- Maximal walking distance on treadmill \< 300 m (treadmill protocol 3.2 km/h, 10% grade);
- Subject receiving from at least one month the recommend medical therapy for LEPAD management (antiplatelet therapy and statin medication).
- Obtained informed consent.
- Healthy volunteers
- Age \> 50 years old;
- Absence of pain reported in the lower limbs during walking as supported by a negative score in the San Diego Questionnaire;
- Absence of any functional limitation during the treadmill walking test: 15 min of walking at 3.2 km/h and 10% slope;
- ABI ≥1.00 and ≤1.40.
- Obtained informed consent.
Exclusion
- Arteriopatic patients :
- Patients with a pacemaker or defibrillator;
- Patients with acute or critical limb ischemia;
- Ambulation limited by exertional symptoms other than intermittent claudication (e.g., dyspnea or angina pectoris);
- Ambulation limited by exertional symptoms indicative of intermittent claudication but affecting muscles in the lower extremities other than the calves;
- Contraindication to exercise testing according to the American Heart Association and the American College of Sports Medicine;
- Major cardiovascular event (myocardial infarction or stroke) or major surgery within the previous three months before inclusion;
- Female patients who are pregnant, planning to become pregnant, or lactating;
- Known presence of an aneurysm of the abdominal aorta \> 4cm or an aneurysm of the iliac artery \>1.5cm;
- Patient subject to legal protection (guardianship or tutelage measure) and persons deprived from their liberty (according to French law);
- Simultaneous participation to another ongoing clinical research protocol;
- Unwilling or unable to engage in the completion of a 12 week programme;
- Any planned event(s) that could interfere with the completion of the protocol: e.g., extended holidays preventing the completion of the intervention or planned hospitalization for a prolonged period of time.
- Body mass \> 160 kg (may exceed treadmill limit).
- Inability to understand and sign informed consent forms due to cognitive or language barriers
- LEPAD due to other causes than atherosclerosis.
- Healthy volunteers :
- Contraindication to walking;
- ABI \<1.00 or \>1.40;
- Inability to obtain a measure of ABI due to uncompressible arteries;
- Limitation(s) and/or symptoms during the treadmill walking test;
- Treadmill walking test uncompleted.
- Presence of hypertension, heart failure, angina pectoris, diabetes, chronic obstructive pulmonary disease, supported by the presence of a medical treatment and the medical history.
- Presence of conditions likely to cause a functional limitation in walking and/or significant modification of physiological responses to the exercise: current or former smoker from less than 6 months, cancer (ongoing), Parkinson's disease, renal failure (ongoing), supported by the presence of a medical treatment and the medical history.
- History of cardiovascular disease (heart failure, stroke, myocardial infarction) reported by the patient.
- Female volunteers who are pregnant, planning to become pregnant, or lactating;
- Volunteers subject to legal protection (guardianship or tutelage measure) and persons deprived from their liberty (according to French law).
- Simultaneous participation to another ongoing clinical research protocol.
- Secondary exclusion criteria for patients :
- Patients requiring a pacemaker or defibrillator within the first three months.
- For the primary endpoint, patients who underwent revascularisation (surgical or endovascular) in the first three months.
- revascularisation (surgical or endovascular) in the first three months.
- 3\. Any health events during the first three months that no longer allow the patient to follow the protocol.
- Burning during the electrostimulation sessions;
- Skin allergy due to the placement of the electro-stimulation electrodes
Key Trial Info
Start Date :
January 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 22 2022
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03795103
Start Date
January 9 2019
End Date
November 22 2022
Last Update
November 23 2022
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
CHU Angers
Angers, France
2
CHU Brest
Brest, France, 29000
3
CHU Caen
Caen, France
4
CHU de Rennes
Rennes, France, 35033