Investigation of the Effects of Electrical Stimulation Applied to Trunk and Lower Extremity Muscles on Pelvic Floor Muscle Strength in Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pelvic Floor Muscle Strength
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Electrical Muscle Stimulation (Device)
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.
干预措施: Standardized Exercise Protocol (Other)
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.
干预措施: Standardized Exercise Protocol (Other)
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
干预措施: Standardized Exercise Protocol (Other)
结局指标
主要结局
Pelvic Floor Muscle Strength
时间窗: 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.
次要结局
未报告次要终点
研究者
Ahmet Cüneyt Akgöl
Assistant Professor
Okan University