Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01820598
Other study ID # 12-AGIR-04
Secondary ID
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
Health authority
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 KneehabĀ® 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/mĀ²)

- 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 Design


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
See also
  Status Clinical Trial Phase
Recruiting NCT04101669 - EndoBarrier System Pivotal Trial(Rev E v2) N/A
Recruiting NCT04243317 - Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults N/A
Terminated NCT03772886 - Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball N/A
Completed NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Completed NCT04506996 - Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2 N/A
Recruiting NCT06019832 - Analysis of Stem and Non-Stem Tibial Component N/A
Active, not recruiting NCT05891834 - Study of INV-202 in Patients With Obesity and Metabolic Syndrome Phase 2
Active, not recruiting NCT05275959 - Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI) N/A
Recruiting NCT04575194 - Study of the Cardiometabolic Effects of Obesity Pharmacotherapy Phase 4
Completed NCT04513769 - Nutritious Eating With Soul at Rare Variety Cafe N/A
Withdrawn NCT03042897 - Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer N/A
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Recruiting NCT05917873 - Metabolic Effects of Four-week Lactate-ketone Ester Supplementation N/A
Active, not recruiting NCT04353258 - Research Intervention to Support Healthy Eating and Exercise N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Completed NCT01870947 - Assisted Exercise in Obese Endometrial Cancer Patients N/A
Recruiting NCT06007404 - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Recruiting NCT05972564 - The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function Phase 1/Phase 2
Recruiting NCT05371496 - Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction Phase 2