NCT07826754

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
4mo left

Started Sep 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress11%
Sep 2026Jan 2027

First Submitted

Initial submission to the registry

September 14, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 17, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

September 20, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 27, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 27, 2027

Last Updated

September 22, 2026

Status Verified

September 1, 2026

Enrollment Period

4 months

First QC Date

September 14, 2026

Last Update Submit

September 17, 2026

Conditions

Keywords

Whole-body electromyostimulation (WB-EMS)Postmenopausal womenCardiometabolic healthQuality of lifeElectromyostimulationObesity6-minute walk test

Outcome Measures

Primary Outcomes (10)

  • Body Mass Index (BMI)

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

    Baseline and after the 16 weeks of the training intervention.

  • 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 %.

    Baseline and after the 16 weeks of the training intervention

  • Waist circumference

    Measured at the narrowest point between the rib cage and iliac crest using a non-elastic tape measure. Measurements expressed in cm.

    Baseline and after the 16 weeks of the training intervention.]

  • Hip circumference

    Measured at the widest point of the hips using a non-elastic tape measure. Measurements expressed in cm.

    Baseline and after the 16 weeks of the training intervention

  • Total Cholesterol

    Plasma total cholesterol concentration (mg/dL).

    Baseline and after the 16 weeks of the training intervention.

  • Triglycerides

    Plasma triglyceride concentration (mg/dL)

    Baseline and after the 16 weeks of the training intervention

  • High-Density Lipoprotein (HDL) Cholesterol

    Plasma HDL cholesterol concentration (mg/dL)

    Baseline and after the 16 weeks of the training intervention

  • Low-Density Lipoprotein (LDL) Cholesterol

    Plasma LDL cholesterol concentration (mg/dL)

    Baseline and after the 16 weeks of the training intervention.

  • 6-Minute Walk Test (6MWT) Distance

    Distance walked in 6 minutes on a 30-meter straight corridor

    Baseline and after the 16 weeks of the training intervention.

  • Menopause-specific quality-of-life score (MENQOL)

    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.

    Baseline and after the 16 weeks of the training intervention

Secondary Outcomes (4)

  • 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

Study Arms (2)

WB-EMS group

EXPERIMENTAL

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.

Other: Whole-body electromyostimulation (WB-EMS) training

Control group

ACTIVE COMPARATOR

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.

Behavioral: Supervised exercise without whole-body electromyostimulation (WB-EMS)

Interventions

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.

WB-EMS group

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.

Control group

Eligibility Criteria

Age48 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Body mass index (BMI) ≥25 kg/m²
  • Age 48-60 years
  • Postmenopausal status, defined as amenorrhea for \>12 consecutive months
  • Stable eating habits

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

High Institute of Sport and Physical Education of Kef, University of Jendouba Kef, Boulifa, Tunisia, 7100

Tunis, Boulifa, 7100, Tunisia

Location

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nejmeddine 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 INVESTIGATOR
  • Nejmeddine Ouerghi

    Research Unit "Sport Sciences, Health and Movement"(UR22JS01) High Institute of Sport and Physical Education of Kef, University of Jendouba, 7100 Kef, Tunisia.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nejmeddine Ouerghi, Ph.D

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

September 14, 2026

First Posted

September 17, 2026

Study Start

September 20, 2026

Primary Completion (Estimated)

January 27, 2027

Study Completion (Estimated)

January 27, 2027

Last Updated

September 22, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

For confidentiality reasons, all data from this study are available upon request

Locations