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

NCT07554612 | Recruiting

• 1 other identifier: E-10840098-50.04-2156
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Women; Muscle Strength; Pelvic Floor

Keywords

Pelvic Floor Muscle Strength; Electrical Muscle Stimulation; Women's Health; EMS

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (3)

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.

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.

Device: Electrical Muscle Stimulation; Other: Standardized Exercise Protocol

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

Other: Standardized Exercise Protocol

Interventions

Electrical Muscle Stimulation DEVICE

Electrical stimulation applied via electrodes integrated into a specialized garment, targeting core and lower extremity muscles.

EMS + Exercise Group; Sham-EMS + Exercise Group

Standardized Exercise Protocol OTHER

A six-week exercise program consisting of specific movements for core and lower limb muscle groups, performed twice weekly

EMS + Exercise Group; Exercise Only Group; Sham-EMS + Exercise Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Only biological female participants are eligible for this study, as the intervention and outcome measures specifically target female pelvic floor anatomy and physiology."
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Okan University: lead

Study Sites (1)

Istanbul Okan University Hospital

Istanbul, Istanbul, 34959, Turkey (Türkiye)

RECRUITING

Study Officials

• Ahmet C AKGÖL, PhD, PT

  Okan University

  STUDY CHAIR

Central Study Contacts

Dilara Taskiran, PT

CONTACT

905308922902; dilarataskrannnn@gmail.com

Ahmet C Akgol, PhD, PT

CONTACT

905327338227; ahmet.akgol@okan.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: April 28, 2026
• Study Start: March 23, 2026
• Primary Completion (Estimated): May 22, 2026
• Study Completion (Estimated): June 19, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Start date is 6 months after publication and no end date
• 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.

Locations

TU (1)