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.

Study Overview

• Status: Unknown
• Conditions: Obesity; Training; Electrical Stimulation; Arterial Stiffness; Cardiovascular
• Intervention / Treatment: Device: Multisite NMES training during 6 weeks

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jean-Louis Pepin, MD, PhD; Phone Number: 476765516; Email: JPepin@chu-grenoble.fr
• Study Contact Backup: Name: Isabelle Vivodtzev, PhD; Phone Number: 476510304; Email: i.vivodtzev@agiradom.com

Study Locations

• France
  • Grenoble, France
    • Recruiting
    • Hopital Universitaire
    • Contact: Jean-Louis Pepin, MD, PhD; Phone Number: 0476765516; Email: JPepin@chu-grenoble.fr
    • Contact: Isabelle, Vivodtzev, PhD; Phone Number: 0476510304; Email: i.vivodtzev@agiradom.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: m-NMES first; Multisite electrostimulator first (Visit 1) and conventional electrostimulator then (Visit 2)	Device: Multisite NMES training during 6 weeks; Other Names: Kneehab(R) Stimulator
Other: c-NMES first; Conventional electrostimulator first (Visit 1) and multisite electrostimulator then (Visit 2)	Device: Multisite NMES training during 6 weeks; Other Names: Kneehab(R) Stimulator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delta arterial stiffness	Change in carotid-femoral Pulse wave velocity (PWV) after NMES sessions	Day1 and Day3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delta pulse arterial tonus (RH-PAT)	change in pulse arterial tonometry after NMES sessions	Day1 and Day3
NMES-induced muscle fatigue	change in maximal voluntary contraction after NMES sessions	Day1 and Day3
Delta blood pressure	changes in systolic and diastolic blood pressures after NMES sessions	Day1 and Day3
Delta plasmatic biomarkers	changes in inflammatory and metabolic plasmatic biomarkers after NMES sessions	Day1 and Day3
Body composition	Fat-free mass and fat-free mass indexes assessed by impedancemetry	Day1, Day21 and Day 42
Spontaneous physical activity	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	Day1 and Day 42
Maximal voluntary contraction	Quadriceps peak force	Day1, Day21 and Day 42
Walking distance	6-minute-walking test	Day1 and Day 42
Arterial stiffness	Pulse wave velocity (PWV) measurements	Day1, Day21 and Day 42
Pulse artery tone (RH-PAT)	Pulse artery tonometry measurement	Day1, Day21 and Day 42
Plasmatic biomarkers	Inflammatory and metabolic biomarkers	Day1, Day21 and Day 42
Blood pressure	Arterial systolic and diastolic blood pressure	Day1, Day21 and Day 42
Response to m-NMES	Delta in current intensity during m-NMES between the first to the last session	Day42

Collaborators and Investigators

• Sponsor: AGIR à Dom
• Collaborators: University Hospital, Grenoble
• Investigators: Principal Investigator: Jean-Louis Pépin, MD, PhD, Laboratoire EFCR, CHU de Grenoble, 38043, Grenoble, France

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Anticipated): November 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: January 15, 2013
• First Submitted That Met QC Criteria: March 26, 2013
• First Posted (Estimate): March 29, 2013

Study Record Updates

• Last Update Posted (Estimate): January 30, 2017
• Last Update Submitted That Met QC Criteria: January 27, 2017
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 12-AGIR-04