Effects of Peripheral Magnetic Stimulation

NCT05524636 | Completed

• 1 other identifier: Fotona
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

subcutaneous fat, magnetic stimulation, abdominal muscles

Outcome Measures

Primary Outcomes (3)

• Change in subcutaneous fat

  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

  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

  Sitting on an unstable surface for 30 seconds

  Baseline, 4 weeks, 8 weeks, 12 weeks after baseline measurement

Study Arms (2)

Experimental

EXPERIMENTAL

Exercise with peripheral magnetic stimulation of the abdominal wall muscles

Device: Exercise with peripheral magnetic stimulation of the abdominal wall muscles

Control

ACTIVE COMPARATOR

Exercise without peripheral magnetic stimulation of the abdominal wall muscles

Other: Exercise of the abdominal wall muscles

Interventions

Exercise with peripheral magnetic stimulation of the abdominal wall muscles DEVICE

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.

Experimental

Exercise of the abdominal wall muscles OTHER

8-week exercise program focused on abdominal wall muscles aiming to reduce subcutaneous fat, increase abdominal wall muscle strength and improve sitting postural control.

Control

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy adults
• BMI between 25,0 and 29,9 kg/m2
• waist circumference above 80 cm for females and above 90 cm for males

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Primorska: lead
• Fotona d.o.o.: collaborator

Study Sites (1)

University of Primorska

Izola, Primorska, 6310, Slovenia

Location

MeSH Terms

Interventions

Exercise Therapy

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Nejc Šarabon, PhD

  Fakulteta za vede o zdravju

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, PhD

Model Details: Experimental and control group

Study Record Dates

• First Submitted: August 25, 2022
• First Posted: September 1, 2022
• Study Start: July 15, 2022
• Primary Completion: July 20, 2022
• Study Completion: July 20, 2022
• Last Updated: September 1, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

SL (1)