Effects of Peripheral Magnetic Stimulation

August 29, 2022 updated by: Nejc Sarabon, University of Primorska

Effects of Abdominal Wall Muscle Training With or Without Additional Peripheral Magnetic Stimulation on Subcutaneous Fat, Muscle Strength and Postural Control

Interventional study of the effectiveness of peripheral magnetic stimulation of the abdominal wall muscles in healthy individuals.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Interventional 8-week study of the effectiveness of peripheral magnetic stimulation of the abdominal wall muscles in healthy individuals. The study will include an experimental and a control group.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovenia
    • Primorska
      • Izola, Primorska, Slovenia, 6310
        • University of Primorska

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy adults
  • BMI between 25,0 and 29,9 kg/m2
  • stable body mass with maximal variation of body mass of 2.2 kg a month prior to the inclusion in the study
  • waist circumference above 80 cm for females and above 90 cm for males

Exclusion Criteria:

  • invasive fat reduction procedures (e.g., liposuction and mesotherapy)
  • weight loss supplements in the month prior to the participation in the study
  • metal implant
  • active implanted electrical device such as a cardiac pacemaker, cochlear implant, intrathecal pump, hearing aids, defibrillator, or drug delivery system

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
Exercise with peripheral magnetic stimulation of the abdominal wall muscles
Device: Exercise with peripheral magnetic stimulation of the abdominal wall muscles
8-week exercise program with peripheral magnetic stimulation, focused on abdominal wall muscles aiming to reduce subcutaneous fat, increase abdominal wall muscle strength and improve sitting postural control.
Active Comparator: Control
Exercise without peripheral magnetic stimulation of the abdominal wall muscles
Other: Exercise of the abdominal wall muscles
8-week exercise program focused on abdominal wall muscles aiming to reduce subcutaneous fat, increase abdominal wall muscle strength and improve sitting postural control.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in subcutaneous fat
Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks after baseline measurement
Subcutaneous fat thickness in the abdominal area measured via ultrasound
Baseline, 4 weeks, 8 weeks, 12 weeks after baseline measurement
Change in maximum isometric peak torque
Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks after baseline measurement
Maximal voluntary isometric contraction of the abdominal muscles. The measurement will be normalized to the body weight (Nm/kg).
Baseline, 4 weeks, 8 weeks, 12 weeks after baseline measurement
Change in sitting postural control
Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks after baseline measurement
Sitting on an unstable surface for 30 seconds
Baseline, 4 weeks, 8 weeks, 12 weeks after baseline measurement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Primorska

Collaborators

Fotona d.o.o.

Investigators

  • Principal Investigator: Nejc Šarabon, PhD, Fakulteta za vede o zdravju

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2022

Primary Completion (Actual)

July 20, 2022

Study Completion (Actual)

July 20, 2022

Study Registration Dates

First Submitted

August 25, 2022

First Submitted That Met QC Criteria

August 29, 2022

First Posted (Actual)

September 1, 2022

Study Record Updates

Last Update Posted (Actual)

September 1, 2022

Last Update Submitted That Met QC Criteria

August 29, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Fotona

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Coded individual data will be uploaded on public scientific data repository.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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