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

NCT03795103 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2022-11-23

No results posted yet for this study

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

Interventions

DEVICE

neuromuscular electrical stimulator

A 12-week program of neuromuscular electrical stimulation

OTHER

Walking sessions

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

OTHER

Advices

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

Sponsors & Collaborators

  • AD REM TECHNOLOGY

    collaborator UNKNOWN

  • Ecole Normale Supérieure de Rennes

    collaborator UNKNOWN

  • Rennes University Hospital

    lead OTHER

Principal Investigators

  • Guillaume Mahe, Pr · Rennes University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
41 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-09
Primary Completion
2022-11-17
Completion
2022-11-22

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03795103 on ClinicalTrials.gov