Feasibility and Effects of Lower-Body Electrical Muscle Stimulation Resistance Training on Body Composition, Muscle Function, Arteriosclerotic Indices, and Autonomic Function in Postmenopausal Women: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
研究概览
简要总结
This pilot randomized controlled trial evaluates whether combining lower-body electrical muscle stimulation (EMS) with resistance training is feasible and beneficial for physically inactive postmenopausal women, who experience concurrent declines in muscle strength, body composition, arterial elasticity, and cardiac autonomic balance.
Sixteen physically inactive postmenopausal women aged 50-70 years are randomly assigned (1:1) to either (A) supervised resistance training combined with lower-body EMS (applied to 6 muscle groups: lower back, lower abdomen, glutes, quadriceps, hamstrings, and calves) or (B) supervised resistance training alone. Both groups complete twelve 50-minute sessions (consisting of a 10-minute warm-up, 30-minute main exercise, and a 10-minute cool-down) over 6 weeks (twice weekly). Assessments before and after the intervention include body composition, lower-body muscle function, arterial stiffness, and 5-minute heart rate variability.
The primary aim is to determine the feasibility of the protocol(recruitment, retention, session attendance, and intervention dose delivery) to inform a future definitive trial. Preliminary estimates of intervention effects on the measured outcomes are reported as secondary aims.
详细描述
BACKGROUND AND RATIONALE Postmenopausal women often experience physiological declines in muscle function, body composition, and cardiovascular health. While resistance training is an established countermeasure, maximizing its efficiency and adherence remains a challenge. Applying lower-body electrical muscle stimulation (EMS) during resistance training may enhance physiological adaptations and overall training effectiveness. This study aims to evaluate the feasibility of combining lower-body EMS with resistance training in physically inactive postmenopausal women to inform the design of a future definitive trial.
STUDY DESIGN This is a pilot randomized controlled trial. Participants will be randomly assigned to either an intervention group receiving combined lower-body EMS and resistance training or a control group receiving resistance training alone. Clinical and physiological outcomes will be assessed before and after the intervention period to evaluate preliminary effects.
PRIMARY FEASIBILITY OUTCOMES
The primary objective is to evaluate the feasibility of the study protocol. Feasibility will be determined by assessing several key components, including:
Recruitment: The ability to recruit the target population within the planned timeframe.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged 50 to 70 years.
- •Menopause for at least 1 year with no current menstruation.
- •Physically inactive (have not participated in resistance training more than twice a week for the past 6 months)
排除标准
- •Currently receiving hormone replacement therapy (HRT).
- •Presence of implanted electrical medical devices.
- •Severe or uncontrolled medical conditions.
- •Any surgery within the past 6 months.
- •Acute illness with fever, infection, or active inflammation.
- •Severe peripheral arterial disease or abdominal/inguinal hernia.
- •Severe psychiatric disorders requiring medication, or current substance abuse.
- •Deemed physically or mentally unfit to participate in the exercise program by the investigator.
研究组 & 干预措施
B Group: Resistance Training
8 machine-based resistance exercises for 6 weeks, 2 sessions per week without EMS.
干预措施: Resistance Training (Behavioral)
A Group: EMS + Resistance Training
Lower-body EMS combined with 8 machine-based resistance exercises for 6 weeks, 2 sessions per week.
干预措施: Lower-Body EMS combined with Resistance Training (Device)
A Group: EMS + Resistance Training
Lower-body EMS combined with 8 machine-based resistance exercises for 6 weeks, 2 sessions per week.
干预措施: Resistance Training (Behavioral)
研究者
Kyungho Kim
Researcher
Seoul National University