Effects of a 16-Week Whole-Body Electromyostimulation Program on Cardiometabolic Markers, Functional Capacity, and Quality of Life in Overweight/Obese Postmenopausal Women: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Body Mass Index (BMI)
研究概览
简要总结
The goal of this randomized controlled trial is to investigate the effects of a 16-week whole-body electromyostimulation (WB-EMS) program on body composition, cardiometabolic health, functional capacity, quality of life, and satisfaction with life in overweight/obese postmenopausal women. The study will examine whether adding WB-EMS to a supervised exercise program results in greater improvements in these outcomes compared with the same exercise program performed without electrical stimulation.
Participants will be randomly allocated to either the WB-EMS group or the control group. Both groups will participate in a 16-week supervised exercise program consisting of two sessions per week, with at least 48 hours between consecutive sessions.
Participants in the WB-EMS group will perform supervised exercise sessions with whole-body electrical stimulation. WB-EMS will be delivered using bipolar electrical impulses at a frequency of 85 Hz and a pulse width of 350 μs, with an intermittent stimulation pattern of 4 seconds of stimulation followed by 4 seconds of rest. The exercise program will include dynamic resistance and functional exercises involving major muscle groups, including squats, lunges, upper-body pushing and pulling movements, and trunk exercises.
The control group will perform the same supervised exercise program without electrical stimulation. Exercise type, session duration, weekly frequency, intervention duration, supervision, and progression will be matched between groups to isolate the additional effects of WB-EMS.
详细描述
This study is designed to investigate the effects of a 16-week whole-body electromyostimulation (WB-EMS) program on body composition, cardiometabolic markers, functional capacity, quality of life, and satisfaction with life in overweight/obese postmenopausal women. A total of 30 overweight/obese postmenopausal women will be randomly allocated to either the whole-body electromyostimulation (WB-EMS) group (n=15) or the control group (n=15). Participants in both groups will participate in a 16-week supervised exercise program consisting of two sessions per week, with at least 48 hours between consecutive sessions.
Participants in the WB-EMS group will perform 20-minute exercise sessions while receiving whole-body electrical stimulation. WB-EMS will be delivered using bipolar electrical impulses at a frequency of 85 Hz and a pulse width of 350 μs, with an intermittent stimulation pattern of 4 seconds of stimulation followed by 4 seconds of rest. During the sessions, participants will perform dynamic resistance and functional exercises involving major muscle groups, including squats, lunges, upper-body pushing and pulling movements, and trunk exercises.
The control group will perform the same supervised exercise program without electrical stimulation. Exercise type, session duration, weekly frequency, intervention duration, supervision, and progression will be matched between groups to isolate the additional effects of WB-EMS.
Outcomes will be assessed at baseline and after the 16-week intervention. The assessments will include body composition, systolic and diastolic blood pressure, resting heart rate, functional capacity assessed using the 6-minute walk test (6MWT), fasting blood glucose, and lipid profile [triglycerides (TG), total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C)]. Quality of life and satisfaction with life will also be assessed using validated questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 48 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Body mass index (BMI) ≥25 kg/m²
- •Age 48-60 years
- •Postmenopausal status, defined as amenorrhea for >12 consecutive months
- •Stable eating habits
排除标准
- •Any medical condition or contraindication that prevents participation in physical exercise
- •Cardiovascular diseases (hypertension or heart failure)
- •Metabolic or inflammatory disorders (uncontrolled diabetes mellitus or autoimmune diseases)
研究组 & 干预措施
WB-EMS group
Participants will participate in a 16-week supervised exercise program consisting of two sessions per week, with at least 48 hours between consecutive sessions. Each session will include 20 minutes of whole-body electromyostimulation (WB-EMS) combined with dynamic resistance and functional exercises involving major muscle groups, including squats, lunges, upper-body pushing and pulling movements, and trunk exercises. WB-EMS will be delivered using bipolar electrical impulses at a frequency of 85 Hz and a pulse width of 350 μs, with an intermittent stimulation pattern of 4 seconds of stimulation followed by 4 seconds of rest. Exercise type, session duration, weekly frequency, supervision, and progression will be standardized throughout the intervention.
干预措施: Whole-body electromyostimulation (WB-EMS) training (Other)
Control group
Participants will participate in the same 16-week supervised exercise program consisting of two sessions per week, with at least 48 hours between consecutive sessions. Participants will perform the same dynamic resistance and functional exercises as the WB-EMS group, including squats, lunges, upper-body pushing and pulling movements, and trunk exercises, but without electrical stimulation. Exercise type, session duration, weekly frequency, supervision, and progression will be matched to those of the WB-EMS group.
干预措施: Supervised exercise without whole-body electromyostimulation (WB-EMS) (Behavioral)
结局指标
主要结局
Body Mass Index (BMI)
时间窗: Baseline and after the 16 weeks of the training intervention.
BMI calculated as weight (kg) divided by height squared (m²)
Body fat percentage
时间窗: Baseline and after the 16 weeks of the training intervention
Bodyfat percentage determined from four skinfold sites (biceps, triceps, subscapular, and supra-iliac) using a calibrated Harpenden Skinfold Caliper. Measurements expressed as %.
Waist circumference
时间窗: Baseline and after the 16 weeks of the training intervention.]
Measured at the narrowest point between the rib cage and iliac crest using a non-elastic tape measure. Measurements expressed in cm.
Hip circumference
时间窗: Baseline and after the 16 weeks of the training intervention
Measured at the widest point of the hips using a non-elastic tape measure. Measurements expressed in cm.
Total Cholesterol
时间窗: Baseline and after the 16 weeks of the training intervention.
Plasma total cholesterol concentration (mg/dL).
Triglycerides
时间窗: Baseline and after the 16 weeks of the training intervention
Plasma triglyceride concentration (mg/dL)
High-Density Lipoprotein (HDL) Cholesterol
时间窗: Baseline and after the 16 weeks of the training intervention
Plasma HDL cholesterol concentration (mg/dL)
Low-Density Lipoprotein (LDL) Cholesterol
时间窗: Baseline and after the 16 weeks of the training intervention.
Plasma LDL cholesterol concentration (mg/dL)
6-Minute Walk Test (6MWT) Distance
时间窗: Baseline and after the 16 weeks of the training intervention.
Distance walked in 6 minutes on a 30-meter straight corridor
Menopause-specific quality-of-life score (MENQOL)
时间窗: Baseline and after the 16 weeks of the training intervention
Menopause-specific quality of life will be assessed using the validated Arabic version of the 29-item Menopause-Specific Quality of Life Questionnaire (MENQOL). Higher scores indicate poorer quality of life.
次要结局
- Fasting glucose(Baseline and after the 16 weeks of the training intervention)
- Blood Pressure (Systolic and Diastolic)(Baseline and after the 16 weeks of the training intervention)
- Resting Heart Rate(Baseline and after the 16 weeks of the training intervention)
- Satisfaction with life(Baseline and after the 16 weeks of the training intervention)
研究者
Nejmeddine Ouerghi
Dr
High Institute of Sports and Physical Education of Kef