Healthy Women, Muscle Strength, Pelvic Floor
Conditions
Keywords
Pelvic Floor Muscle Strength, Electrical Muscle Stimulation, Women's Health, EMS
Brief summary
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.
Detailed description
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.
Interventions
Electrical stimulation applied via electrodes integrated into a specialized garment, targeting core and lower extremity muscles.
OTHERStandardized Exercise Protocol
A six-week exercise program consisting of specific movements for core and lower limb muscle groups, performed twice weekly
Sponsors
Okan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Biological female volunteers aged between 18 and 45 years. * Having a Body Mass Index (BMI) between 18.5 and 29.9 kg/m². * Being sedentary or having a low level of physical activity (not participating in regular exercise programs in the last 6 months). * Volunteering to participate in the study and signing the informed consent form. * Being mentally and physically capable of following the 12-week exercise and EMS protocol.
Exclusion criteria
* Having a history of pelvic floor surgery or major abdominal surgery. * Being pregnant or having given birth within the last 6 months. * Having a diagnosed neurological disorder that affects muscle control (e.g., Multiple Sclerosis, Parkinson's). * Having an active urinary tract infection or symptomatic pelvic organ prolapse. * Having a cardiac pacemaker or any metal implants in the trunk and hip area (contraindications for EMS). * Having chronic diseases that may interfere with exercise participation (e.g., uncontrolled hypertension, severe cardiovascular disease). * Having skin lesions, infections, or severe sensitivity in the areas where EMS electrodes will be applied. * Using medications that affect muscle metabolism or the neuromuscular system.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pelvic Floor Muscle Strength | Baseline (Week 0), Mid-intervention (Week 7), and Follow-up (Week 12) | 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTDilara Taskiran, PT
CONTACTAhmet C Akgol, PhD, PT
STUDY_CHAIRAhmet C AKGÖL, PhD, PT
Okan University
Outcome results
None listed