High Institute of Sport and Physical Education of Kef, University of Jendouba Kef, Boulifa, Tunisia, 7100
Tunis, Boulifa, 7100, Tunisia
NCT Number: NCT07826754
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.
Trial opening soon.
Get Notified48 year–60 year
Female
Interventional
Not applicable
Tunis, Boulifa, 7100, Tunisia
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Baseline and after the 16 weeks of the training intervention.
BMI calculated as weight (kg) divided by height squared (m²)
Time frame: 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 %.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and after the 16 weeks of the training intervention.
Plasma total cholesterol concentration (mg/dL).
Time frame: Baseline and after the 16 weeks of the training intervention
Plasma triglyceride concentration (mg/dL)
Time frame: Baseline and after the 16 weeks of the training intervention
Plasma HDL cholesterol concentration (mg/dL)
Time frame: Baseline and after the 16 weeks of the training intervention.
Plasma LDL cholesterol concentration (mg/dL)
Time frame: Baseline and after the 16 weeks of the training intervention.
Distance walked in 6 minutes on a 30-meter straight corridor
Time frame: 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.
Time frame: Baseline and after the 16 weeks of the training intervention
Fasting plasma glucose concentration (mmol/L).
Time frame: Baseline and after the 16 weeks of the training intervention
Measured using an automated arm cuff (Omron BP652)
Time frame: Baseline and after the 16 weeks of the training intervention
Measured using automated device (Omron BP652)
Time frame: 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
Trial opening soon.
Get NotifiedHigh Institute of Sports and Physical Education of Kef
Other
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
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