Obesity Clinical Trial
— StimobIIOfficial 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.
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 |
Country | Name | City | State |
---|---|---|---|
France | Hopital Universitaire | Grenoble |
Lead Sponsor | Collaborator |
---|---|
AGIR à Dom | University Hospital, Grenoble |
France,
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 |
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