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A Multicenter, Investigator-Blinded, Randomized Controlled Trial to Assess the Efficacy of Calf Neuromuscular Electrical Stimulation Program on Walking Performance in Peripheral Artery Disease: The ELECTRO-PAD Study Protocol

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  • معلومة اضافية
    • Contributors:
      Centre d'Investigation Clinique Rennes (CIC); Université de Rennes (UR)-Centre Hospitalier Universitaire de Rennes CHU Rennes = Rennes University Hospital Pontchaillou -Institut National de la Santé et de la Recherche Médicale (INSERM); Laboratoire Mouvement Sport Santé (M2S); Université de Rennes (UR)-École normale supérieure - Rennes (ENS Rennes)-Université de Rennes 2 (UR2)-Structure Fédérative de Recherche en Biologie et Santé de Rennes (Biosit : Biologie - Santé - Innovation Technologique); Centre Hospitalier Universitaire de Rennes CHU Rennes = Rennes University Hospital Pontchaillou; University of Limerick (UL); Centre Hospitalier Régional Universitaire de Brest (CHRU Brest); Centre Hospitalier Universitaire d'Angers (CHU Angers); PRES Université Nantes Angers Le Mans (UNAM); CHU Caen; Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN); This trial is promoted by the university hospital of Rennes and is supported by a grant from the French Ministry of Health (API 2015, PHRC—“Programme Hospitalier de Recherche Clinique”-n°API15/R/040). The Ad Rem Technology manufacturer also provided non-financial (provision of electro-stimulators and electrodes) and financial support to this trial. The “Ecole normale supérieure of Rennes” (Rennes, France), a public institution of higher education and research (institution of A.L.F.), provided non-financial support to the study (provision of activity monitors). A. Chanteau received a PhD scholarship from the “École normale supérieure” of Rennes. All these funding sources had also no role in the design of this study and will not have any role during its execution, analysis, interpretation of the data, or decision to submit results.
    • بيانات النشر:
      CCSD
      MDPI
    • الموضوع:
      2022
    • Collection:
      Normandie Université: HAL
    • نبذة مختصرة :
      International audience ; This paper describes a currently on-going multicenter, randomized controlled trial designed to assess the efficacy of calf neuromuscular electrical stimulation (NMES) on changes in maximal walking distance in people with lower extremity peripheral artery disease (PAD), compared with a non-intervention control-group. This study (NCT03795103) encompasses five participating centers in France. PAD participants with a predominant claudication at the calf level and a maximal treadmill walking distance ≤300 m are randomized into one of the two groups: NMES group or Control group. The NMES program consists of a 12-week program of electrical stimulations at the calf-muscle level. The primary outcome of the study is the change in maximal treadmill walking distance at 12 weeks. Main secondary outcomes include changes in the pain-free treadmill walking distance; 6 min total walking distance; global positioning system (GPS)-measured outdoor walking capacity; daily physical activity level by accelerometry; self-reported walking impairment; self-reported quality of life; ankle-brachial index; and skin microvascular function, both at the forearm and calf levels. Recruitment started in September 2019 and data collection is expected to end in November 2022.
    • Relation:
      info:eu-repo/semantics/altIdentifier/pmid/36555879; PUBMED: 36555879
    • الرقم المعرف:
      10.3390/jcm11247261
    • الدخول الالكتروني :
      https://hal.science/hal-03927137
      https://hal.science/hal-03927137v1/document
      https://hal.science/hal-03927137v1/file/jcm-11-07261.pdf
      https://doi.org/10.3390/jcm11247261
    • Rights:
      http://creativecommons.org/licenses/by/ ; info:eu-repo/semantics/OpenAccess
    • الرقم المعرف:
      edsbas.E0987F05