Effects of Peripheral Magnetic Stimulation

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05524636
• Other study ID #: Fotona
• Status: Completed
• Phase: N/A
• Start date: July 15, 2022
• Est. completion date: July 20, 2022

Study information

• Verified date: August 2022
• Source: University of Primorska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 20, 2022
• Est. primary completion date: July 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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.

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.

Locations

Country	Name	City	State
Slovenia	University of Primorska	Izola	Primorska

Sponsors (2)

Lead Sponsor	Collaborator
University of Primorska	Fotona d.o.o.

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in subcutaneous fat	Subcutaneous fat thickness in the abdominal area measured via ultrasound	Baseline, 4 weeks, 8 weeks, 12 weeks after baseline measurement
Primary	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
Primary	Change in sitting postural control	Sitting on an unstable surface for 30 seconds	Baseline, 4 weeks, 8 weeks, 12 weeks after baseline measurement