Phase II Study of Neuromuscular Electrical Multisite System on Cardiovascular Effects in Severe Obese Patients

Obesity Clinical Trial

— StimobII  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01820598
• Other study ID #: 12-AGIR-04
• Status: Recruiting
• Phase: N/A
• First received: January 15, 2013
• Last updated: January 27, 2017
• Start date: January 2013
• Est. completion date: December 2017

Study information

• Verified date: July 2016
• Source: AGIR à Dom
• Contact: Jean-Louis Pepin, MD, PhD
• Phone: 476765516
• Email: JPepin[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arterial Stiffness
• Cardiovascular
• Electrical Stimulation
• Obesity
• Training

Intervention

Device:
• Multisite NMES training during 6 weeks

Locations

Country	Name	City	State
France	Hopital Universitaire	Grenoble

Sponsors (2)

Lead Sponsor	Collaborator
AGIR à Dom	University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

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