Healthy WomenNCT07554612
The Impact of Trunk and Lower Extremity Electrical Stimulation on Pelvic Floor Muscle Strength in Females
A study testing Electrical Muscle Stimulation and Standardized Exercise Protocol in people with Healthy Women and Muscle Strength, run by Okan University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Women, Muscle Strength, Pelvic Floor
- What is being tested?
- Electrical Muscle Stimulation and Standardized Exercise Protocol
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Mar 2026to 15 Jun 2026
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Okan University Hospital
Istanbul, Istanbul, 34959
About this study
Official title: Investigation of the Effects of Electrical Stimulation Applied to Trunk and Lower Extremity Muscles on Pelvic Floor Muscle Strength in Women
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.
Read the 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.
- Conditions
- Healthy Women, Muscle Strength, Pelvic Floor
- Being tested
- Electrical Muscle Stimulation, Standardized Exercise Protocol, Sham (No Treatment)
- Keywords
- Pelvic Floor Muscle Strength, Electrical Muscle Stimulation, Women's Health, EMS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical Muscle StimulationDevice
Electrical stimulation applied via electrodes integrated into a specialized garment, targeting core and lower extremity muscles.
Standardized Exercise ProtocolOther
A six-week exercise program consisting of specific movements for core and lower limb muscle groups, performed twice weekly
Sham (No Treatment)Device
Also called Sham EMS
The application of electrical stimulation that is only felt sensorially, not at a level that can induce muscle contraction.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Electrical Muscle Stimulation; Other: Standardized Exercise Protocol |
| 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. Receives: Other: Standardized Exercise Protocol; Device: Sham (No Treatment) |
| 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 Receives: Other: Standardized Exercise Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Week 0), Mid-intervention (Week 7), and Follow-up (Week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study start23 Mar 2026
- Primary completion15 Jun 2026
- Study completion15 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy WomenStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Okan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet Cüneyt Akgöl, Okan University
- Investigators
- Ahmet C AKGÖL, PhD, PT, Study chair, Okan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07554612
- Sponsor's protocol ID
- E-10840098-50.04-2156
- Status last verified
- Jun 2026
- First submitted
- 21 Apr 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Electrical Stimulation Applied to Trunk and Lower Extremity Muscles on Pelvic Floor Muscle Strength in Women
- ClinicalTrials.gov ID
- NCT07554612
- Acronym / sponsor ID
- E-10840098-50.04-2156
- Conditions
- Healthy Women, Muscle Strength, Pelvic Floor
- Keywords
- Pelvic Floor Muscle Strength, Electrical Muscle Stimulation, Women's Health, EMS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Okan UniversityUniversity, hospital or other
- Study start
- 23 Mar 2026 (actual)
- Primary completion
- 15 Jun 2026 (actual)
- Study completion
- 15 Jun 2026 (actual)
- First posted
- 28 Apr 2026 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EMS + Exercise Group | Experimental | Device: Electrical Muscle Stimulation, Other: Standardized Exercise ProtocolParticipants 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. |
| Sham-EMS + Exercise Group | Placebo comparator | Other: Standardized Exercise Protocol, Device: Sham (No Treatment)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. |
| Exercise Only Group | Active comparator | Other: Standardized Exercise ProtocolParticipants 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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).
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 |
|---|---|---|
| Electrical Muscle StimulationElectrical stimulation applied via electrodes integrated into a specialized garment, targeting core and lower extremity muscles. | Device | EMS + Exercise Group |
| Standardized Exercise ProtocolA six-week exercise program consisting of specific movements for core and lower limb muscle groups, performed twice weekly | Other | EMS + Exercise Group, Exercise Only Group, Sham-EMS + Exercise Group |
| Sham (No Treatment)Also: Sham EMSThe application of electrical stimulation that is only felt sensorially, not at a level that can induce muscle contraction. | Device | Sham-EMS + Exercise Group |
Primary outcome
Pelvic Floor Muscle Strength
Time frame: 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.
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 26 Jun 2026.
- Individual participant dataSharing planned: Yes. 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.
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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.
Ahmet C AKGÖL, PhD, PT study chair
Okan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical Muscle Stimulation and Standardized Exercise Protocol in people with Healthy Women and Muscle Strength, run by Okan University at 1 site in Turkey (Türkiye).
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 5 inclusion and 8 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 26 Jun 2026. 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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?
Pelvic Floor Muscle Strength (time frame: Baseline (Week 0), Mid-intervention (Week 7), and Follow-up (Week 12)). 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 26 Jun 2026.