Obesity Clinical Trial
Official title:
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.
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.
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