Effects of Whole-Body Electromyostimulation in Overweight/Obese Postmenopausal Women

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age48-60
SponsorHigh Institute of Sports and Physical Education of Kef

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Body mass index (BMI) ≥25 kg/m²

Age 48-60 years

Postmenopausal status, defined as amenorrhea for >12 consecutive months

Stable eating habits

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Whole-body electromyostimulation (WB-EMS) training

    Other intervention

    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.

  • Supervised exercise without whole-body electromyostimulation (WB-EMS)

    Behavioral

    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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: WB-EMS groupExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Body Mass Index (BMI)

BMI calculated as weight (kg) divided by height squared (m²)

Time frame
Baseline and after the 16 weeks of the training intervention.
2

Body fat percentage

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
3

Waist circumference

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.]
4

Hip circumference

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

Secondary outcomes

1

Fasting glucose

Fasting plasma glucose concentration (mmol/L).

Time frame
Baseline and after the 16 weeks of the training intervention
2

Blood Pressure (Systolic and Diastolic)

Measured using an automated arm cuff (Omron BP652)

Time frame
Baseline and after the 16 weeks of the training intervention
3

Resting Heart Rate

Measured using automated device (Omron BP652)

Time frame
Baseline and after the 16 weeks of the training intervention
4

Satisfaction with life

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

Time frame
Baseline and after the 16 weeks of the training intervention

Other outcomes

Sponsors and contacts

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