HealthyNCT05524636
Effects of Peripheral Magnetic Stimulation
A study testing Exercise with peripheral magnetic stimulation of the abdominal wall muscles and Exercise of the abdominal wall muscles in people with Healthy, run by University of Primorska at 1 site in Slovenia.
Trial summary
Interventional study of the effectiveness of peripheral magnetic stimulation of the abdominal wall muscles in healthy individuals. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Exercise with peripheral magnetic stimulation of the abdominal wall muscles and Exercise of the abdominal wall muscles
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSlovenia
- Study dates
- 15 Jul 2022to 20 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Exercise with peripheral magnetic stimulation of the abdominal wall muscles, Exercise of the abdominal wall muscles
- Keywords
- subcutaneous fat, magnetic stimulation, abdominal muscles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise with peripheral magnetic stimulation of the abdominal wall musclesDevice
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.
Exercise of the abdominal wall musclesOther
8-week exercise program focused on abdominal wall muscles aiming to reduce subcutaneous fat, increase abdominal wall muscle strength and improve sitting postural control.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Exercise with peripheral magnetic stimulation of the abdominal wall muscles Receives: Device: Exercise with peripheral magnetic stimulation of the abdominal wall muscles |
| Control | Active comparator | Exercise without peripheral magnetic stimulation of the abdominal wall muscles Receives: Other: Exercise of the abdominal wall muscles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in subcutaneous fat
Subcutaneous fat thickness in the abdominal area measured via ultrasound
Measured: 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).
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks after baseline measurement
Change in sitting postural control
Sitting on an unstable surface for 30 seconds
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks after baseline measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2022
- Study start15 Jul 2022
- Primary completion20 Jul 2022
- Study completion20 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental and control group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Primorska
- Sponsor type
- University, hospital or other
- Collaborators
- Fotona d.o.o.
- Responsible party
- Principal investigator, Nejc Sarabon, University of Primorska
- Investigators
- Nejc Šarabon, PhD, Principal investigator, Fakulteta za vede o zdravju
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05524636
- Sponsor's protocol ID
- Fotona
- Status last verified
- Aug 2022
- First submitted
- 25 Aug 2022
- Last updated
- 1 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Coded individual data will be uploaded on public scientific data repository.
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Abdominal Wall Muscle Training With or Without Additional Peripheral Magnetic Stimulation on Subcutaneous Fat, Muscle Strength and Postural Control
- ClinicalTrials.gov ID
- NCT05524636
- Acronym / sponsor ID
- Fotona
- Conditions
- Healthy
- Keywords
- subcutaneous fat, magnetic stimulation, abdominal muscles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of PrimorskaUniversity, hospital or other
- Collaborators
- Fotona d.o.o.
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- 20 Jul 2022 (actual)
- Study completion
- 20 Jul 2022 (actual)
- First posted
- 1 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Interventional study of the effectiveness of peripheral magnetic stimulation of the abdominal wall muscles in healthy individuals.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Experimental and control group
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: Exercise with peripheral magnetic stimulation of the abdominal wall musclesExercise with peripheral magnetic stimulation of the abdominal wall muscles |
| Control | Active comparator | Other: Exercise of the abdominal wall musclesExercise without peripheral magnetic stimulation of the abdominal wall muscles |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise with peripheral magnetic stimulation of the abdominal wall muscles8-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. | Device | Experimental |
| Exercise of the abdominal wall muscles8-week exercise program focused on abdominal wall muscles aiming to reduce subcutaneous fat, increase abdominal wall muscle strength and improve sitting postural control. | Other | Control |
Primary outcome
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
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).
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2022.
- Individual participant dataSharing planned: Yes. Coded individual data will be uploaded on public scientific data repository.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nejc Šarabon, PhD principal investigator
Fakulteta za vede o zdravju
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise with peripheral magnetic stimulation of the abdominal wall muscles and Exercise of the abdominal wall muscles in people with Healthy, run by University of Primorska at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in subcutaneous fat (time frame: Baseline, 4 weeks, 8 weeks, 12 weeks after baseline measurement). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2022.