NCT05117203

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 11, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

November 11, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2022

Completed
Last Updated

October 14, 2022

Status Verified

October 1, 2022

Enrollment Period

6 months

First QC Date

October 25, 2021

Last Update Submit

October 13, 2022

Conditions

Keywords

Whole body electrostimulationhealthyabdominal musclesultrasoundRUSIWB-EMS

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (8)

  • International physical activity questionnaire (IPAQ)

    One day

  • Nijgemen questionnaire

    One day

  • Body height

    One day

  • Body weight

    One day

  • Body mass index

    One day

  • +3 more secondary outcomes

Study Arms (3)

WB-EMS group

EXPERIMENTAL
Device: WB-EMS (Whole body electrostimulation)

EMS group

EXPERIMENTAL
Device: EMS

Control group

SHAM COMPARATOR
Device: WB-EMS off

Interventions

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

WB-EMS group
EMSDEVICE

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

EMS 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).

Also known as: Control group
Control group

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad de León

Ponferrada, León, 24401, Spain

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 25, 2021

First Posted

November 11, 2021

Study Start

November 11, 2021

Primary Completion

May 10, 2022

Study Completion

June 15, 2022

Last Updated

October 14, 2022

Record last verified: 2022-10

Locations