ObesitySTIMOBIIINCT02210585
Study of Neuromuscular Electrical Stimulation to Increase Spontaneous Physical Activity in Obesity Patient
A study testing Rehabilitation in people with Obesity and Number of Steps Per Day < 7000, run by University Hospital, Grenoble at 3 sites in France.
Trial summary
The study was designed to test the following hypotheses: Main Objective: To compare the level of spontaneous physical activity at 3 months after re-entrainment by multi-site electrical stimulation (m-ES), measured by actigraphy over 7 days, compared to conventional care (lifestyle and dietary advice and placebo… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Obesity, Number of Steps Per Day < 7000
- What is being tested?
- Rehabilitation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- 3 sitesFrance
- Study dates
- 9 Apr 2014to May 2024
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Obese patients with BMI > 35 kg/m²
- Continuous Positive Airway Pressure (CPAP) treatment and > 4h observance per night to the patient with OSAS (obstructive sleep apnoea syndrome)
- Patients who give written consent
- Patients who subscribed social insurance
Who cannot join
- Cardiovascular or respiratory failure discovered at the moment of the inclusion in the study
- Contraindication to exercise
- Pregnant or breast-feed woman
- Patients under guardianship
- Imprisoned patients
Trial locations and contacts
3 sites in 1 country.
France3 sites
Hôpital Universitaire de Grenoble
Grenoble, 38043
Hôpital universitaire de Lyon
Lyon, 69310
Hôpital universitaire de Saint Etienne
Saint-Etienne, 42055
About this study
Official title: Study of Multi-site Neuromuscular Electrical Stimulation to Increase Spontaneous Physical Activity in Obesity Patient Carrying Severe Inactive: Randomized Controlled Trial vs Placebo
The study was designed to test the following hypotheses:
Main Objective:
Read more
To compare the level of spontaneous physical activity at 3 months after re-entrainment by multi-site electrical stimulation (m-ES), measured by actigraphy over 7 days, compared to conventional care (lifestyle and dietary advice and placebo (simulated) electrostimulation) (control arm).
Secondary Objectives:
To compare the metabolic, inflammatory, cardiovascular and functional parameters, physical activity, quality of life and quality of sleep, at 3 months and at 2 years in the two groups.
Design:
We will conduct a multicenter controlled study vs. reference care with randomization into two parallel groups and double-blind (placebo electrostimulation). Patients will have the ES material available at home and will be supervised by monthly visits over 3 months and by telephone follow-up for two years. The study size calculation is based on physical activity, the percentage of lean body mass and arterial stiffness measured in the OBEX study (NCT01155271).
This project will determine whether the training strategy is effective for increasing physical activity and/or in inducing significant metabolic and cardiovascular effects in these patients after 2 years. In addition, it provides a solid base of investigation for the study of the interactions between muscle contraction and cardio-metabolic health with greater precision.
Read the detailed description
Obesity and sleep apnea syndrome lead to metabolic troubles and increasing cardiovascular risk. Furthermore, both diseases are associated with reduced exercise tolerance.
For many patients with morbid obesity, the implementation of physical activity programs remains difficult for several reasons including the level of disability and psychosocial causes (the scrutiny of others, depression and poorly adapted equipment).
Main hypothesis: Neuromuscular electrostimulation is a way to increase spontaneous physical activity (PA) in treated apneic obese patients with low spontaneous physical activity
- Conditions
- Obesity, Number of Steps Per Day < 7000
- Being tested
- Rehabilitation
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RehabilitationOther
12 weeks : 5 sessions per week (1 supervised session at home every month)
92 weeks : spontaneous training (supervised by phone every month)
| Study group | Role | What they receive |
|---|---|---|
| Kneehab® | Active comparator | 5 sessions per week Receives: Other: Rehabilitation |
| Placebo | Placebo comparator | 5 sessions per week Receives: Other: Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in physical activity
- Number of steps per day
- Number of MET (metabolic equivalent of task) per day
Measured: After a period of monthly supervised training program by neuromuscular electrical stimulation at home (12th wk)
Secondary outcomes (8)
Changes in body composition
Fat mass and fat-mass index as assessed by impedancemetry measurements
Measured: After a period of monthly supervised training by neuromuscular electrical stimulation at home (12th wk) and during a period of spontaneous training (48 th, 72 th, 96 th week)
Change in arterial stiffness
Pulse wave velocity
Measured: After a period of monthly supervised training by neuromuscular electrical stimulation at home (12th wk) and during a period of spontaneous training (48 th, 72 th, 96 th week)
Change in endothelial function
Peripheral arterial tone (RH-PAT)
Measured: After a period of monthly supervised training by neuromuscular electrical stimulation at home (12th wk) and after a period of spontaneous training (92th week )
Change in plasmatic biomarkers
Oxidative stress and inflammatory blood parameters
Measured: After a period of monthly supervised training by neuromuscular electrical stimulation at home (12th wk) and after a period of spontaneous training (92th week )
Change in quality of life
SF-12 questionnaire
Measured: After a period of monthly supervised training by neuromuscular electrical stimulation at home (12th wk) and after a period of spontaneous training (92th week )
Number of cardiovascular events per year
Questionnaire sent to the patient by mail
Measured: Every year from the 1st to the 2th year
Change in other parameters of physical activity
Energy expenditure (total and during daily activities)
Measured: After a period of monthly supervised training by neuromuscular electrical stimulation at home (12th wk) and during a period of spontaneous training (48 th, 72 th, 96 th week)
Change in sleep quality
Lying and sleep duration
Measured: After a period of monthly supervised training by neuromuscular electrical stimulation at home (12th wk) and during a period of spontaneous training (48 th, 72 th, 96 th week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2014 (estimated)
- Study start9 Apr 2014
- Primary completionMay 2024
- Study completionMay 2024
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.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Renaud TAMISIER, Pr, Principal investigator, Laboratoire EFCR, CHU de Grenoble, 38043, Grenoble, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02210585
- Sponsor's protocol ID
- 38RC13.554
- Acronym
- STIMOBIII
- Status last verified
- May 2024
- First submitted
- 5 Aug 2014
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Multi-site Neuromuscular Electrical Stimulation to Increase Spontaneous Physical Activity in Obesity Patient Carrying Severe Inactive: Randomized Controlled Trial vs Placebo
- ClinicalTrials.gov ID
- NCT02210585
- Acronym / sponsor ID
- STIMOBIII / 38RC13.554
- Conditions
- Obesity, Number of Steps Per Day < 7000
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 9 Apr 2014 (actual)
- Primary completion
- May 2024 (actual)
- Study completion
- May 2024 (actual)
- First posted
- 6 Aug 2014 (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:
Main Objective:
To compare the level of spontaneous physical activity at 3 months after re-entrainment by multi-site electrical stimulation (m-ES), measured by actigraphy over 7 days, compared to conventional care (lifestyle and dietary advice and placebo (simulated) electrostimulation) (control arm).
Secondary Objectives:
To compare the metabolic, inflammatory, cardiovascular and functional parameters, physical activity, quality of life and quality of sleep, at 3 months and at 2 years in the two groups.
Design:
We will conduct a multicenter controlled study vs. reference care with randomization into two parallel groups and double-blind (placebo electrostimulation). Patients will have the ES material available at home and will be supervised by monthly visits over 3 months and by telephone follow-up for two years. The study size calculation is based on physical activity, the percentage of lean body mass and arterial stiffness measured in the OBEX study (NCT01155271).
This project will determine whether the training strategy is effective for increasing physical activity and/or in inducing significant metabolic and cardiovascular effects in these patients after 2 years. In addition, it provides a solid base of investigation for the study of the interactions between muscle contraction and cardio-metabolic health with greater precision.
Detailed description
Obesity and sleep apnea syndrome lead to metabolic troubles and increasing cardiovascular risk. Furthermore, both diseases are associated with reduced exercise tolerance.
For many patients with morbid obesity, the implementation of physical activity programs remains difficult for several reasons including the level of disability and psychosocial causes (the scrutiny of others, depression and poorly adapted equipment).
Main hypothesis: Neuromuscular electrostimulation is a way to increase spontaneous physical activity (PA) in treated apneic obese patients with low spontaneous physical activity
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kneehab® | Active comparator | Other: Rehabilitation5 sessions per week |
| Placebo | Placebo comparator | Other: Rehabilitation5 sessions per week |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Obese patients with BMI > 35 kg/m²
- Continuous Positive Airway Pressure (CPAP) treatment and > 4h observance per night to the patient with OSAS (obstructive sleep apnoea syndrome)
- Patients who give written consent
- Patients who subscribed social insurance
Key exclusion criteria (5 listed)
- Cardiovascular or respiratory failure discovered at the moment of the inclusion in the study
- Contraindication to exercise
- Pregnant or breast-feed woman
- Patients under guardianship
- Imprisoned patients
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 |
|---|---|---|
| Rehabilitation12 weeks : 5 sessions per week (1 supervised session at home every month) 92 weeks : spontaneous training (supervised by phone every month) | Other | Kneehab®, Placebo |
Primary outcome
Change in physical activity
Time frame: After a period of monthly supervised training program by neuromuscular electrical stimulation at home (12th wk)
* Number of steps per day * Number of MET (metabolic equivalent of task) per day
8 secondary outcomes
Changes in body composition
Time frame: After a period of monthly supervised training by neuromuscular electrical stimulation at home (12th wk) and during a period of spontaneous training (48 th, 72 th, 96 th week)
Change in arterial stiffness
Time frame: After a period of monthly supervised training by neuromuscular electrical stimulation at home (12th wk) and during a period of spontaneous training (48 th, 72 th, 96 th week)
Change in endothelial function
Time frame: After a period of monthly supervised training by neuromuscular electrical stimulation at home (12th wk) and after a period of spontaneous training (92th week )
Change in plasmatic biomarkers
Time frame: After a period of monthly supervised training by neuromuscular electrical stimulation at home (12th wk) and after a period of spontaneous training (92th week )
Change in quality of life
Time frame: After a period of monthly supervised training by neuromuscular electrical stimulation at home (12th wk) and after a period of spontaneous training (92th week )
Number of cardiovascular events per year
Time frame: Every year from the 1st to the 2th year
Change in other parameters of physical activity
Time frame: After a period of monthly supervised training by neuromuscular electrical stimulation at home (12th wk) and during a period of spontaneous training (48 th, 72 th, 96 th week)
Change in sleep quality
Time frame: After a period of monthly supervised training by neuromuscular electrical stimulation at home (12th wk) and during a period of spontaneous training (48 th, 72 th, 96 th week)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
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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.
Renaud TAMISIER, Pr principal investigator
Laboratoire EFCR, CHU de Grenoble, 38043, Grenoble, France
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation in people with Obesity and Number of Steps Per Day < 7000, run by University Hospital, Grenoble at 3 sites 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in physical activity (time frame: After a period of monthly supervised training program by neuromuscular electrical stimulation at home (12th wk)). 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 16 May 2024.