Dynamic Electrostimulation on the Abdominal Muscles in Healthy Individuals

NCT ID: NCT05117203

Last Updated: 2022-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-11

Study Completion Date

2022-06-15

Brief Summary

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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

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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

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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WB-EMS group

Group Type EXPERIMENTAL

WB-EMS (Whole body electrostimulation)

Intervention Type 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)

EMS group

Group Type EXPERIMENTAL

EMS

Intervention Type DEVICE

Application of physical exercise and electrical stimulation on the abdominal muscles through the EMS during 20 minutes training session with specific exercise (CORE)

Control group

Group Type SHAM_COMPARATOR

WB-EMS off

Intervention Type DEVICE

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).

Interventions

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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)

Intervention Type DEVICE

EMS

Application of physical exercise and electrical stimulation on the abdominal muscles through the EMS during 20 minutes training session with specific exercise (CORE)

Intervention Type DEVICE

WB-EMS off

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).

Intervention Type DEVICE

Other Intervention Names

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Control group

Eligibility Criteria

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Inclusion Criteria

* Healthy participants
* Good medical history without injury or chest pain in the past year
* No surgeries in the previous year.

Exclusion Criteria

* 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
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad de León

OTHER

Sponsor Role lead

Responsible Party

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Lorena Álvarez del Barrio

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Universidad de León

Ponferrada, León, Spain

Site Status

Countries

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Spain

Other Identifiers

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ETICA-ULE-009-2020

Identifier Type: -

Identifier Source: org_study_id

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