Dynamic Electrostimulation on the Abdominal Muscles in Healthy Individuals

Healthy Clinical Trial

Official title:

Immediate Effects of Dynamic Electrostimulation on the Abdominal Muscles in Healthy Individuals, Assessed by Ultrasound: an Experimental Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05117203
• Other study ID #: ETICA-ULE-009-2020
• Status: Completed
• Phase: N/A
• Start date: November 11, 2021
• Est. completion date: June 15, 2022

Study information

• Verified date: October 2022
• Source: Universidad de León
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 exercise session. The same intervention is carried out for the control group as the WB-EMS group but simulated.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 15, 2022
• Est. primary completion date: May 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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)
• EMS
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 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).

Locations

Country	Name	City	State
Spain	Universidad de León	Ponferrada	León

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de León

Country where clinical trial is conducted

Spain, 

Outcome

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