Cardiometabolic Health in Overweight/Obese Postmenopausal Women
Conditions
Keywords
Whole-body electromyostimulation (WB-EMS), Postmenopausal women, Cardiometabolic health, Quality of life, Electromyostimulation, Obesity, 6-minute walk test
Brief summary
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.
Detailed description
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.
Interventions
OTHERWhole-body electromyostimulation (WB-EMS) training
Participants will complete a 16-week supervised exercise program consisting of two sessions per week, with at least 48 hours between consecutive sessions. The WB-EMS group will perform 20-minute sessions while receiving bipolar electrical stimulation at 85 Hz with a pulse width of 350 μs, using an intermittent 4-second stimulation/4-second rest pattern. Exercises will include squats, lunges, upper-body pushing and pulling movements, and trunk exercises targeting major muscle groups. Stimulation intensity will be individually adjusted according to participants' tolerance, with a target perceived intensity of approximately 5-7 on a 0-10 scale.
BEHAVIORALSupervised exercise without whole-body electromyostimulation (WB-EMS)
The control group will perform the same 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 effect of WB-EMS.
Sponsors
High Institute of Sports and Physical Education of Kef
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
48 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Body mass index (BMI) ≥25 kg/m² * Age 48-60 years * Postmenopausal status, defined as amenorrhea for \>12 consecutive months * Stable eating habits
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body Mass Index (BMI) | Baseline and after the 16 weeks of the training intervention. | BMI calculated as weight (kg) divided by height squared (m²) |
| Body fat percentage | 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 | 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 | 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 | Baseline and after the 16 weeks of the training intervention. | Plasma total cholesterol concentration (mg/dL). |
| Triglycerides | Baseline and after the 16 weeks of the training intervention | Plasma triglyceride concentration (mg/dL) |
| High-Density Lipoprotein (HDL) Cholesterol | Baseline and after the 16 weeks of the training intervention | Plasma HDL cholesterol concentration (mg/dL) |
| Low-Density Lipoprotein (LDL) Cholesterol | Baseline and after the 16 weeks of the training intervention. | Plasma LDL cholesterol concentration (mg/dL) |
| 6-Minute Walk Test (6MWT) Distance | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fasting glucose | Baseline and after the 16 weeks of the training intervention | Fasting plasma glucose concentration (mmol/L). |
| Blood Pressure (Systolic and Diastolic) | Baseline and after the 16 weeks of the training intervention | Measured using an automated arm cuff (Omron BP652) |
| Resting Heart Rate | Baseline and after the 16 weeks of the training intervention | Measured using automated device (Omron BP652) |
| Satisfaction with life | Baseline and after the 16 weeks of the training intervention | Global life satisfaction will be assessed using the validated Arabic version of the 5-item Satisfaction with Life Scale (SWLS). Each item is scored from 1 to 7, with a total score ranging from 5 to 35. Higher scores indicate greater satisfaction with life |
Countries
Tunisia
Contacts
CONTACTNejmeddine Ouerghi, Ph.D
PRINCIPAL_INVESTIGATORNejmeddine Ouerghi, Ph.D
Research Unit "Sport Sciences, Health and Movement"(UR22JS01) High Institute of Sport and Physical Education of Kef, University of Jendouba, 7100 Kef, Tunisia.
PRINCIPAL_INVESTIGATORNejmeddine Ouerghi
Research Unit "Sport Sciences, Health and Movement"(UR22JS01) High Institute of Sport and Physical Education of Kef, University of Jendouba, 7100 Kef, Tunisia.
Outcome results
None listed