HealthyNCT05117203
Dynamic Electrostimulation on the Abdominal Muscles in Healthy Individuals
A study testing WB-EMS (Whole body electrostimulation), EMS and WB-EMS off in people with Healthy, run by Universidad de León at 1 site in Spain.
Trial summary
To determine the immediate effects on the abdominal musculature, assessed by ultrasound (RUSI), due to the application of electrostimulation using whole body electrostimulation together with physical exercise in healthy people and to compare with the application of local EMS in the abdominal area and the same physical… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- WB-EMS (Whole body electrostimulation), EMS and WB-EMS off
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 11 Nov 2021to 15 Jun 2022
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy participants
- Good medical history without injury or chest pain in the past year
- No surgeries in the previous year.
Who cannot join
- Upper body mass index 30 Kg/m2
- Level of professional or elite sports activity
- Hyperventilation / hypercapnia and score above 23 points on the Nijmegen questionnaire
- Present any contraindication regarding the WB-EMS/EMS
- Viral o bacterial infections
- Arterial circulatory disorders, advanced arteriosclerosis
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- Women during their menstrual period
- Type I diabetes, hemophilia, bruises, bleeding, cognitive deficit, fibromyalgia, congenital diseases with muscle-skeletal alterations at the level of the back and lower extremities, scoliosis, protrusion or disc herniation, medication consumption, abdominal surgeries (scars or keloids), abdominal muscle injury.
- Presence of chronic low back, hip or thigh pain
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immediate Effects of Dynamic Electrostimulation on the Abdominal Muscles in Healthy Individuals, Assessed by Ultrasound: an Experimental Study
To determine the immediate effects on the abdominal musculature, assessed by ultrasound (RUSI), due to the application of electrostimulation using whole body electrostimulation together with physical exercise in healthy people and to compare with the application of local EMS in the abdominal area and the same physical exercise session. The same intervention is carried out for the control group as the WB-EMS group but simulated.
Read the detailed description
Evaluation of the immediate changes in the thickness of the abdominal muscles (Transversus abdominis, Internal and External Oblique and Rectus abdominis) and in the Interrectus distance after the physical exercise session together with whole body electrostimulation or local electrostimulation assessed by ultrasound (RUSI) in healthy people.
- Conditions
- Healthy
- Being tested
- WB-EMS (Whole body electrostimulation), EMS, WB-EMS off
- Keywords
- Whole body electrostimulation, healthy, abdominal muscles, ultrasound, RUSI, WB-EMS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WB-EMS (Whole body electrostimulation)Device
Application of physical exercise and electrical stimulation on the abdominal muscles through the WB-EMS during 20 minutes training session with specific exercise (CORE)
EMSDevice
Application of physical exercise and electrical stimulation on the abdominal muscles through the EMS during 20 minutes training session with specific exercise (CORE)
WB-EMS offDevice
Also called Control group
Application of physical exercise without electrical stimulation on the abdominal muscles through the WB-EMS off during a 20 minutes training session with specific exercise (CORE).
| Study group | Role | What they receive |
|---|---|---|
| WB-EMS group | Experimental | Not described Receives: Device: WB-EMS (Whole body electrostimulation) |
| EMS group | Experimental | Not described Receives: Device: EMS |
| Control group | Sham comparator | Not described Receives: Device: WB-EMS off |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of muscle thickness of the abdominal muscles by ultrasound through the technique "Rehabilitative Ultrasound Imaging" (RUSI).
Measure muscle thickness before and after exercise with electrostimulation
Measured: One day
Measurement of the Distance between Rectus abdominis using ultrasound (RUSI)
Measure the distance between Rectus abdominis before and after exercise with electrostimulation
Measured: One day
Secondary outcomes (8)
International physical activity questionnaire (IPAQ)
Classification according to low, moderate or high physical activity level
Measured: One day
Nijgemen questionnaire
A level of respiratory distress equal to or higher than 23 points is an exclusion criterion for exclusion from the study
Measured: One day
Body height
Body height in meters
Measured: One day
Body weight
Body weight in kilograms
Measured: One day
Body mass index
Calculation of body mass index in Kg/m2 according to Queletet method
Measured: One day
Heart frequency
Measurement of the heart rate (beats per minute)
Measured: One day
Blood pressure
Measurement of systolic and diastolic blood pressure using a sphygmomanometer
Measured: One day
body temperature
Measurement of body temperature in Celsius with a digital thermometer
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start11 Nov 2021
- Primary completion10 May 2022
- Study completion15 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de León
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lorena Álvarez del Barrio, Universidad de León
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05117203
- Sponsor's protocol ID
- ETICA-ULE-009-2020
- Status last verified
- Oct 2022
- First submitted
- 25 Oct 2021
- Last updated
- 14 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effects of Dynamic Electrostimulation on the Abdominal Muscles in Healthy Individuals, Assessed by Ultrasound: an Experimental Study
- ClinicalTrials.gov ID
- NCT05117203
- Acronym / sponsor ID
- ETICA-ULE-009-2020
- Conditions
- Healthy
- Keywords
- Whole body electrostimulation, healthy, abdominal muscles, ultrasound, RUSI, WB-EMS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Universidad de LeónUniversity, hospital or other
- Study start
- 11 Nov 2021 (actual)
- Primary completion
- 10 May 2022 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 11 Nov 2021 (actual)
- 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.
To determine the immediate effects on the abdominal musculature, assessed by ultrasound (RUSI), due to the application of electrostimulation using whole body electrostimulation together with physical exercise in healthy people and to compare with the application of local EMS in the abdominal area and the same physical exercise session. The same intervention is carried out for the control group as the WB-EMS group but simulated.
Detailed description
Evaluation of the immediate changes in the thickness of the abdominal muscles (Transversus abdominis, Internal and External Oblique and Rectus abdominis) and in the Interrectus distance after the physical exercise session together with whole body electrostimulation or local electrostimulation assessed by ultrasound (RUSI) in healthy people.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| WB-EMS group | Experimental | Device: WB-EMS (Whole body electrostimulation) |
| EMS group | Experimental | Device: EMS |
| Control group | Sham comparator | Device: WB-EMS off |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy participants
- Good medical history without injury or chest pain in the past year
- No surgeries in the previous year.
Key exclusion criteria (9 listed)
- Upper body mass index 30 Kg/m2
- Level of professional or elite sports activity
- Hyperventilation / hypercapnia and score above 23 points on the Nijmegen questionnaire
- Present any contraindication regarding the WB-EMS/EMS
- Viral o bacterial infections
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 |
|---|---|---|
| WB-EMS (Whole body electrostimulation)Application of physical exercise and electrical stimulation on the abdominal muscles through the WB-EMS during 20 minutes training session with specific exercise (CORE) | Device | WB-EMS group |
| EMSApplication of physical exercise and electrical stimulation on the abdominal muscles through the EMS during 20 minutes training session with specific exercise (CORE) | Device | EMS group |
| WB-EMS offAlso: Control groupApplication of physical exercise without electrical stimulation on the abdominal muscles through the WB-EMS off during a 20 minutes training session with specific exercise (CORE). | Device | Control group |
Primary outcome
Measurement of muscle thickness of the abdominal muscles by ultrasound through the technique "Rehabilitative Ultrasound Imaging" (RUSI).
Time frame: One day
Measure muscle thickness before and after exercise with electrostimulation
Measurement of the Distance between Rectus abdominis using ultrasound (RUSI)
Time frame: One day
Measure the distance between Rectus abdominis before and after exercise with electrostimulation
8 secondary outcomes
International physical activity questionnaire (IPAQ)
Time frame: One day
Nijgemen questionnaire
Time frame: One day
Body height
Time frame: One day
Body weight
Time frame: One day
Body mass index
Time frame: One day
Heart frequency
Time frame: One day
Blood pressure
Time frame: One day
body temperature
Time frame: one day
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 14 Oct 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WB-EMS (Whole body electrostimulation), EMS and WB-EMS off in people with Healthy, run by Universidad de León at 1 site in Spain.
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 3 inclusion and 9 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 14 Oct 2022. 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 Spain. 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?
Measurement of muscle thickness of the abdominal muscles by ultrasound through the technique "Rehabilitative Ultrasound Imaging" (RUSI). (time frame: One day). The study lists 2 primary outcomes in all. 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 14 Oct 2022.