Dynamic Electrostimulation on the Abdominal Muscles in Healthy Individuals

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Device: WB-EMS (Whole body electrostimulation); Device: EMS; Device: WB-EMS off

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • León
    • Ponferrada, León, Spain, 24401
      • Universidad de León

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Control group	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).; Other Names: Control group
Experimental: EMS group	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)
Experimental: WB-EMS group	Device: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	One day
Measurement of the Distance between Rectus abdominis using ultrasound (RUSI)	Measure the distance between Rectus abdominis before and after exercise with electrostimulation	One day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
International physical activity questionnaire (IPAQ)	Classification according to low, moderate or high physical activity level	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	One day
Body height	Body height in meters	One day
Body weight	Body weight in kilograms	One day
Body mass index	Calculation of body mass index in Kg/m2 according to Queletet method	One day
Heart frequency	Measurement of the heart rate (beats per minute)	One day
Blood pressure	Measurement of systolic and diastolic blood pressure using a sphygmomanometer	One day
body temperature	Measurement of body temperature in Celsius with a digital thermometer	one day

Collaborators and Investigators

• Sponsor: Universidad de León

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2021
• Primary Completion (Actual): May 10, 2022
• Study Completion (Actual): June 15, 2022

Study Registration Dates

• First Submitted: October 25, 2021
• First Submitted That Met QC Criteria: November 1, 2021
• First Posted (Actual): November 11, 2021

Study Record Updates

• Last Update Posted (Actual): October 14, 2022
• Last Update Submitted That Met QC Criteria: October 13, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: ultrasound; healthy; WB-EMS; abdominal muscles; Whole body electrostimulation; RUSI
• Other Study ID Numbers: ETICA-ULE-009-2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No