The Impact of Trunk and Lower Extremity Electrical Stimulation on Pelvic Floor Muscle Strength in Females

April 21, 2026 updated by: Ahmet Cüneyt Akgöl, Okan University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
    • Istanbul
      • Istanbul, Istanbul, Turkey (Türkiye), 34959
        • Recruiting
        • Istanbul Okan University Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ahmet C Akgol, PhD, PT
        • Sub-Investigator:
          • Dilara Taskiran, PT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EMS + Exercise Group
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.
Device: Electrical Muscle Stimulation
Electrical stimulation applied via electrodes integrated into a specialized garment, targeting core and lower extremity muscles.
Other: Standardized Exercise Protocol
A six-week exercise program consisting of specific movements for core and lower limb muscle groups, performed twice weekly
Placebo Comparator: Sham-EMS + Exercise Group
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.
Device: Electrical Muscle Stimulation
Electrical stimulation applied via electrodes integrated into a specialized garment, targeting core and lower extremity muscles.
Other: Standardized Exercise Protocol
A six-week exercise program consisting of specific movements for core and lower limb muscle groups, performed twice weekly
Active Comparator: Exercise Only Group
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
Other: Standardized Exercise Protocol
A six-week exercise program consisting of specific movements for core and lower limb muscle groups, performed twice weekly

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (Week 0), Mid-intervention (Week 7), and Follow-up (Week 12)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Okan University

Investigators

  • Study Chair: Ahmet C AKGÖL, PhD, PT, Okan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 23, 2026

Primary Completion (Estimated)

May 22, 2026

Study Completion (Estimated)

June 19, 2026

Study Registration Dates

First Submitted

April 21, 2026

First Submitted That Met QC Criteria

April 21, 2026

First Posted (Actual)

April 28, 2026

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • E-10840098-50.04-2156

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Start date is 6 months after publication and no end date

IPD Sharing Access Criteria

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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Muscle Strength

Clinical Trials on Electrical Muscle Stimulation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malaysia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe