Effect of a Neuromuscular Electrical Stimulation Program on Walking Capacity in Peripheral Artery Disease Patients

NCT03795103 | Completed

• 1 other identifier: 35RC15_8961_ELECTROPAD
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 5

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. 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.

Conditions

Arteriopathy

Keywords

Lower Extremity Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• 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)

  12 weeks

Secondary Outcomes (13)

• Change in treadmill walking distance to onset of leg pain

  12 weeks

• Change in 6-minute total walk distance

  12 weeks

• Change in maximal walking distance and medium walking speed under natural outdoor conditions

  12 weeks

• Change in the Walking Impairment Questionnaire score

  12 weeks

• Change in the Short Form (36) Health Survey (SF36) score

  12 weeks

Study Arms (3)

Patients achieving neuromuscular electrical stimulation

EXPERIMENTAL

LEPAD patients achieving a 12-week program of neuromuscular electrical stimulation. Group of arteriopathic patients who will perform electrostimulation sessions at home and independently. These patients will also receive a study participation guide that will include an information leaflet outlining tips for active living and walking.

Device: neuromuscular electrical stimulator

Control

OTHER

Group of artriopathic patients who will maintain their usual drug management. These patients will also receive a study participation guide that will include an information leaflet outlining tips for active living and walking.

Other: Advices

Healthy volunteers

OTHER

Ancillary study. Participants will perform a precise program of walking sessions performed outdoors and independently and the same biological parameters as those assessed in arteriopathic patients will be assessed

Other: Walking sessions

Interventions

neuromuscular electrical stimulator DEVICE

A 12-week program of neuromuscular electrical stimulation

Patients achieving neuromuscular electrical stimulation

Walking sessions OTHER

A 12-week program of walking sessions performed outdoors and independently

Healthy volunteers

Advices OTHER

The usual practice associated with an information leaflet outlining tips for active living and walking.

Control

Eligibility Criteria

• Age: 41 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Rennes University Hospital: lead
• AD REM TECHNOLOGY: collaborator
• Ecole Normale Supérieure de Rennes: collaborator

Study Sites (5)

CHU Angers

Angers, France

Location

CHU Brest

Brest, 29000, France

Location

CHU Caen

Caen, France

Location

CHU de Rennes

Rennes, 35033, France

Location

Hôpital de Rangueil

Toulouse, 31403, France

Location

Related Publications (1)

• Jehannin P, Craughwell M, Omarjee L, Donnelly A, Jaquinandi V, Mahe G, Le Faucheur A. A systematic review of lower extremity electrical stimulation for treatment of walking impairment in peripheral artery disease. Vasc Med. 2020 Aug;25(4):354-363. doi: 10.1177/1358863X20902272. Epub 2020 Apr 17.

  PMID: 32303155 DERIVED

MeSH Terms

Interventions

Counseling

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Guillaume Mahe, Pr

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Investigators won't know which arm is allocated to arteriopathic patients. Program will be send to patients by a outcome research engineer
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2018
• First Posted: January 7, 2019
• Study Start: January 9, 2019
• Primary Completion: November 17, 2022
• Study Completion: November 22, 2022
• Last Updated: November 23, 2022

Record last verified: 2022-11

Locations

FR (5)