Phase II Study of Neuromuscular Electrical Multisite System on Cardiovascular Effects in Severe Obese Patients (StimobII)
Acute and Medium-term Effects of Neuromuscular Electrical Multisite System (Kneehab®) on Cardiovascular Parameters and Induced Muscle Fatigue in Morbidly Obese Patients: Comparison With the Unidirectional Standard Device
The study was designed to test the following hypotheses:
In patients with severe obesity, a multisite electrostimulation session (m-NMES) will induce higher changes in metabolic, inflammatory and cardiovascular parameters and higher increase in muscle strength during stimulated contractions than conventional unidirectional electrostimulation session (c-NMES).
In patients with severe obesity, a six-weeks m-NMES training program will enhance cardiovascular, metabolic and inflammatory parameters.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Background: Physical activity is known to reduce cardiovascular risk as far as even minor change in lifestyle could occur. In obesity, physical activity programs remain challenging due to multifactorial causes related to body mass such as shortness of breath, traumatological pain or psychosocial causes. Although neuromuscular electrical stimulation training is presently ignored in the management of obesity, this technique may be appropriate and useful for muscle deconditioning in these patients. Furthermore, direct effects of electrostimulation training program on vascular function have been previously reported in spinal cord injury and chronic heart disease, suggesting that improvement in cardiovascular function may be expected. While a promising new technique of multisite electrical stimulation (the Kneehab® system) has been recently commercialized, few study have investigated the acute effects of electrostimulation on vascular function and not any study report the effects of electrical stimulation in obese patients.
MAIN OUTCOME OF THE ACUTE PHASE STUDY (1st part):To study the effect of multisite electrical stimulation session (m-NMES) on arterial stiffness as compared to conventional unidirectional electrical stimulation session (c-NMES) in patients with severe obesity. Secondary outcomes of the observational study: 1/ To study the effect of m-NMES on endothelial function, blood pressure, systemic inflammation and metabolic status (fasting glucose and insulin) as well as electrically-induced muscle fatigue as compared with c-NMES in patients with morbid obesity. 2/ To study the profile of responders to electrical stimulation according to body composition, 6-minute walking distance, spontaneous physical activity or susceptibility to tolerate electrical stimulation. Response to electrical stimulation will be assessed by an improvement in arterial stiffness after stimulation, if so.
MAIN OUTCOME OF THE INTERVENTIONAL STUDY (2nd part):To study the effect of a multisite electrical stimulation training program (m-NMES) (6 weeks, 30 sessions) on arterial stiffness in patients with severe obesity. Secondary outcomes of the interventional study: To study the effect of m-NMES on endothelial function, blood pressure, systemic inflammation and metabolic status (fasting glucose and insulin) as well as muscle strength, body composition, functional capacity (6-minute walking distance) and spontaneous physical activity, after 15 sessions (3 weeks) and after 30 sessions (6 weeks) of training program. Evaluation of the dose-response to m-NMES training in terms of arterial stiffness and functional capacity.
Expected outcomes: Acute change in arterial stiffness and/or endothelial function is expected after one m-NMES session and/or after c-NMES session. M-NMES session is expected to induce higher changes than c-NMES stimulation session on cardiovascular and muscle parameters. Chronic changes in arterial stiffness and/or endothelial function is expected after 6 weeks of m-NMES training.
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Grenoble, France
- Recrutement
- Hopital Universitaire
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Contact:
- Jean-Louis Pepin, MD, PhD
- Numéro de téléphone: 0476765516
- E-mail: JPepin@chu-grenoble.fr
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Contact:
- Isabelle, Vivodtzev, PhD
- Numéro de téléphone: 0476510304
- E-mail: i.vivodtzev@agiradom.com
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Male or female, aged over 18 years
- Morbid obesity (BMI > 35 kg/m²)
- Not included into exercise training program in the year prior to inclusion- Spontaneous physical activity lower than 160 min wk (i.e. < 30 min/d x 5 d/wk).
Additional Inclusion criteria for the interventional study:
- Patients with PWV > 9.3 m / s
Exclusion Criteria:
- Underage- Pregnant or parturient women
- Persons deprived of their liberty for judicial or administrative reasons, person under a legal protection measure (article L1121-8)
- Exclusion period in other studies- Person not affiliated to a social security scheme
- Chronic alcoholism
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Autre: m-NMES first
Multisite electrostimulator first (Visit 1) and conventional electrostimulator then (Visit 2)
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Autres noms:
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Autre: c-NMES first
Conventional electrostimulator first (Visit 1) and multisite electrostimulator then (Visit 2)
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Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Delta arterial stiffness
Délai: Day1 and Day3
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Change in carotid-femoral Pulse wave velocity (PWV) after NMES sessions
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Day1 and Day3
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Delta pulse arterial tonus (RH-PAT)
Délai: Day1 and Day3
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change in pulse arterial tonometry after NMES sessions
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Day1 and Day3
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NMES-induced muscle fatigue
Délai: Day1 and Day3
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change in maximal voluntary contraction after NMES sessions
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Day1 and Day3
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Delta blood pressure
Délai: Day1 and Day3
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changes in systolic and diastolic blood pressures after NMES sessions
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Day1 and Day3
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Delta plasmatic biomarkers
Délai: Day1 and Day3
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changes in inflammatory and metabolic plasmatic biomarkers after NMES sessions
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Day1 and Day3
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Body composition
Délai: Day1, Day21 and Day 42
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Fat-free mass and fat-free mass indexes assessed by impedancemetry
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Day1, Day21 and Day 42
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Spontaneous physical activity
Délai: Day1 and Day 42
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Number of hours per day of physical activity at 1, 2, 3, 4 or 5 metabolic equivalent(METS),Number of step per day,using a 7-days actigraphy
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Day1 and Day 42
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Maximal voluntary contraction
Délai: Day1, Day21 and Day 42
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Quadriceps peak force
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Day1, Day21 and Day 42
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Walking distance
Délai: Day1 and Day 42
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6-minute-walking test
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Day1 and Day 42
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Arterial stiffness
Délai: Day1, Day21 and Day 42
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Pulse wave velocity (PWV) measurements
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Day1, Day21 and Day 42
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Pulse artery tone (RH-PAT)
Délai: Day1, Day21 and Day 42
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Pulse artery tonometry measurement
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Day1, Day21 and Day 42
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Plasmatic biomarkers
Délai: Day1, Day21 and Day 42
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Inflammatory and metabolic biomarkers
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Day1, Day21 and Day 42
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Blood pressure
Délai: Day1, Day21 and Day 42
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Arterial systolic and diastolic blood pressure
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Day1, Day21 and Day 42
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Response to m-NMES
Délai: Day42
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Delta in current intensity during m-NMES between the first to the last session
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Day42
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Jean-Louis Pépin, MD, PhD, Laboratoire EFCR, CHU de Grenoble, 38043, Grenoble, France
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 12-AGIR-04
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