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This study aims to investigate the effects of whole-body electrical muscle stimulation (EMS) applied to the trunk and lower extremity muscles on pelvic floor muscle strength in healthy women. Since pelvic floor muscles are deep-seated and can be difficult to activate voluntarily, this research explores whether stimulating related muscle groups (core and legs) can provide an indirect benefit to pelvic floor strength. Participants will be divided into three groups (EMS + exercise, Sham-EMS + exercise, and exercise only) and will undergo a 6-week intervention program. Changes in pelvic floor muscle strength will be evaluated using a perineometer to determine the effectiveness of this non-invasive approach.
The primary aim of this clinical study is to evaluate the indirect effect of Electrical Muscle Stimulation (EMS) applied to the lower extremity and trunk muscles on pelvic floor muscle (PFM) strength in healthy women. While PFM training is the gold standard in women's health, many individuals experience difficulty in isolating and effectively contracting these muscles. This study aims to create an effective EMS application by leveraging the physiological synergy between the core/lower extremity muscles and the pelvic floor.
All participants will attend a comprehensive 6-week intervention program with sessions scheduled twice weekly. During these sessions, specific exercises targeting major muscle groups will be performed. For relevant groups, electrical stimulation synchronized with these movements will be applied to increase muscle fiber activation.
PFM strength will be assessed using a digital perineometer at two time points: baseline (pre-intervention) and at the end of the 6-week program (post-intervention). To ensure consistency, all measurements will be taken by the same investigator. The aim of this study is to determine whether systemic activation of trunk and lower extremity muscles via EMS leads to a measurable increase in pelvic floor muscle tone and strength, thus offering a novel, non-invasive supportive method in physiotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EMS + Exercise Group | Experimental | Participants in this group will undergo a combined intervention of localized Electrical Muscle Stimulation (EMS) and a standardized exercise protocol. The EMS will be delivered via electrodes integrated into a specialized garment, specifically targeting the core (trunk) and lower extremity muscle groups. The program will be conducted twice weekly for a total of 6 weeks. During each session, electrical stimulation will be synchronized with specific exercises designed to engage the core and lower limbs. The stimulation parameters (frequency, pulse width, and intensity) will be adjusted according to each participant's individual sensory and motor tolerance to ensure optimal muscle fiber recruitment without causing discomfort. |
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| Sham-EMS + Exercise Group | Placebo Comparator | Participants in this group will undergo a sham-controlled intervention combined with a standardized exercise protocol. To maintain the blinding process, participants will wear the identical specialized garment with integrated electrodes targeting the core and lower extremity muscle groups. The sessions will be held twice weekly for 6 weeks. During these sessions, the EMS device will be applied at an intensity that does not induce any muscle contractions, ensuring that no therapeutic electrical stimulation is delivered while the participants perform the standardized exercise protocol. This setup is designed to control for the placebo effect of wearing the EMS equipment and participating in the exercise routine. |
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| Exercise Only Group | Active Comparator | Participants in this group will perform a standardized exercise protocol designed to target the major muscle groups of the trunk and lower extremities. The program will be conducted twice weekly for a total of 6 weeks. These participants will not receive any electrical muscle stimulation (EMS) but will follow the same exercise routine as the experimental and sham groups to provide a baseline for the effectiveness of exercise alone on pelvic floor muscle strength |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electrical Muscle Stimulation | Device | Electrical stimulation applied via electrodes integrated into a specialized garment, targeting core and lower extremity muscles. |
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| Measure | Description | Time Frame |
|---|---|---|
| Pelvic Floor Muscle Strength | Evaluation of the maximal voluntary contraction of the pelvic floor muscles. A mechanical perineometer with a pressure gauge will be used to measure the pressure changes. | Baseline (Week 0), Mid-intervention (Week 7), and Follow-up (Week 12) |
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Inclusion Criteria:
Exclusion Criteria:
Only biological female participants are eligible for this study, as the intervention and outcome measures specifically target female pelvic floor anatomy and physiology."
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| Name | Affiliation | Role |
|---|---|---|
| Ahmet C AKGÖL, PhD, PT | Okan University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul Okan University Hospital | Istanbul | Istanbul | 34959 | Turkey (Türkiye) |
De-identified individual participant data, the study protocol, and the informed consent form will be made available upon reasonable request to the corresponding author, following the publication of the study results. Data will be shared for the purpose of further scientific research.
Start date is 6 months after publication and no end date
De-identified individual participant data and supporting documents (Study Protocol, Informed Consent Form) will be available to qualified academic researchers. Access will be provided to those who intend to use the data for further scientific research or meta-analysis. To gain access, data requestors must submit a formal request and a brief research proposal to the corresponding author (Ahmet Cüneyt Akgöl) via email. Data will be shared via a secure file transfer method after the research proposal is reviewed and approved by the principal investigator.
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Participants in the sham EMS group will follow exactly the same procedures as those in the intervention group; they will wear the identical EMS suit and perform the same exercise protocol. To maintain blinding, the EMS device in the sham group will be set to an intensity below the sensory threshold (or an intensity that does not induce muscle contractions) without the participants' knowledge.
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| Standardized Exercise Protocol | Other | A six-week exercise program consisting of specific movements for core and lower limb muscle groups, performed twice weekly |
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| Sham (No Treatment) | Device | The application of electrical stimulation that is only felt sensorially, not at a level that can induce muscle contraction. |
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