ObesityStimobIINCT01820598
Phase II Study of Neuromuscular Electrical Multisite System on Cardiovascular Effects in Severe Obese Patients
A study testing Multisite NMES training during 6 weeks in people with Obesity and Arterial Stiffness, run by AGIR à Dom at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Arterial Stiffness, Electrical Stimulation
- What is being tested?
- Multisite NMES training during 6 weeks
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2013to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hopital Universitaire
Grenoble
Jean-Louis Pepin, MD, PhD, 0476765516, JPepin@chu-grenoble.fr
Isabelle, Vivodtzev, PhD, 0476510304, i.vivodtzev@agiradom.com
About this study
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.
Read the 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.
- Conditions
- Obesity, Arterial Stiffness, Electrical Stimulation, Training, Cardiovascular
- Being tested
- Multisite NMES training during 6 weeks
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multisite NMES training during 6 weeksDevice
Also called Kneehab(R) Stimulator
| Study group | Role | What they receive |
|---|---|---|
| m-NMES first | Other | Multisite electrostimulator first (Visit 1) and conventional electrostimulator then (Visit 2) Receives: Device: Multisite NMES training during 6 weeks |
| c-NMES first | Other | Conventional electrostimulator first (Visit 1) and multisite electrostimulator then (Visit 2) Receives: Device: Multisite NMES training during 6 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delta arterial stiffness
Change in carotid-femoral Pulse wave velocity (PWV) after NMES sessions
Measured: Day1 and Day3
Secondary outcomes (13)
Delta pulse arterial tonus (RH-PAT)
change in pulse arterial tonometry after NMES sessions
Measured: Day1 and Day3
NMES-induced muscle fatigue
change in maximal voluntary contraction after NMES sessions
Measured: Day1 and Day3
Delta blood pressure
changes in systolic and diastolic blood pressures after NMES sessions
Measured: Day1 and Day3
Delta plasmatic biomarkers
changes in inflammatory and metabolic plasmatic biomarkers after NMES sessions
Measured: Day1 and Day3
Body composition
Fat-free mass and fat-free mass indexes assessed by impedancemetry
Measured: 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
Measured: Day1 and Day 42
Maximal voluntary contraction
Quadriceps peak force
Measured: Day1, Day21 and Day 42
Walking distance
6-minute-walking test
Measured: Day1 and Day 42
Arterial stiffness
Pulse wave velocity (PWV) measurements
Measured: Day1, Day21 and Day 42
Pulse artery tone (RH-PAT)
Pulse artery tonometry measurement
Measured: Day1, Day21 and Day 42
Plasmatic biomarkers
Inflammatory and metabolic biomarkers
Measured: Day1, Day21 and Day 42
Blood pressure
Arterial systolic and diastolic blood pressure
Measured: Day1, Day21 and Day 42
Response to m-NMES
Delta in current intensity during m-NMES between the first to the last session
Measured: Day42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2013 (estimated)
- Study startJan 2013
- Primary completionNov 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AGIR à Dom
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Grenoble
- Responsible party
- Sponsor
- Investigators
- Jean-Louis Pépin, MD, PhD, Principal investigator, Laboratoire EFCR, CHU de Grenoble, 38043, Grenoble, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01820598
- Sponsor's protocol ID
- 12-AGIR-04
- Acronym
- StimobII
- Status last verified
- Jul 2016
- First submitted
- 15 Jan 2013
- Last updated
- 30 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01820598
- Acronym / sponsor ID
- StimobII / 12-AGIR-04
- Conditions
- Obesity, Arterial Stiffness, Electrical Stimulation, Training, Cardiovascular
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- AGIR à DomUniversity, hospital or other
- Collaborators
- University Hospital, Grenoble
- Study start
- Jan 2013
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 29 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| m-NMES first | Other | Device: Multisite NMES training during 6 weeksMultisite electrostimulator first (Visit 1) and conventional electrostimulator then (Visit 2) |
| c-NMES first | Other | Device: Multisite NMES training during 6 weeksConventional electrostimulator first (Visit 1) and multisite electrostimulator then (Visit 2) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
- Patients with PWV > 9.3 m / s
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multisite NMES training during 6 weeksAlso: Kneehab(R) Stimulator | Device | c-NMES first, m-NMES first |
Primary outcome
Delta arterial stiffness
Time frame: Day1 and Day3
Change in carotid-femoral Pulse wave velocity (PWV) after NMES sessions
13 secondary outcomes
Delta pulse arterial tonus (RH-PAT)
Time frame: Day1 and Day3
NMES-induced muscle fatigue
Time frame: Day1 and Day3
Delta blood pressure
Time frame: Day1 and Day3
Delta plasmatic biomarkers
Time frame: Day1 and Day3
Body composition
Time frame: Day1, Day21 and Day 42
Spontaneous physical activity
Time frame: Day1 and Day 42
Maximal voluntary contraction
Time frame: Day1, Day21 and Day 42
Walking distance
Time frame: Day1 and Day 42
Arterial stiffness
Time frame: Day1, Day21 and Day 42
Pulse artery tone (RH-PAT)
Time frame: Day1, Day21 and Day 42
Plasmatic biomarkers
Time frame: Day1, Day21 and Day 42
Blood pressure
Time frame: Day1, Day21 and Day 42
Response to m-NMES
Time frame: Day42
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Louis Pépin, MD, PhD principal investigator
Laboratoire EFCR, CHU de Grenoble, 38043, Grenoble, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multisite NMES training during 6 weeks in people with Obesity and Arterial Stiffness, run by AGIR à Dom at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-Louis Pepin, MD, PhD (476765516, JPepin@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delta arterial stiffness (time frame: Day1 and Day3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2017; AzTrials last refreshed its copy on 6 Nov 2026.