Postmenopausal WomenNCT07826754
Effects of Whole-Body Electromyostimulation in Overweight/Obese Postmenopausal Women
A study testing Whole-body electromyostimulation (WB-EMS) training and Supervised exercise without whole-body electromyostimulation (WB-EMS) in people with Postmenopausal Women and Overweight, run by High Institute of Sports and Physical Education of Kef at 1 site in Tunisia.
Trial 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. Read more about this study
- Who is it for?
- Ages 48 to 60 years, women only
- Conditions the study is for
- Postmenopausal Women, Overweight, Obesity
- What is being tested?
- Whole-body electromyostimulation (WB-EMS) training and Supervised exercise without whole-body electromyostimulation (WB-EMS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTunisia
- Study dates
- 20 Sep 2026to 27 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 48 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Body mass index (BMI) ≥25 kg/m²
- Age 48-60 years
- Postmenopausal status, defined as amenorrhea for >12 consecutive months
- Stable eating habits
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tunisia1 site
High Institute of Sport and Physical Education of Kef, University of Jendouba Kef, Boulifa, Tunisia, 7100
Tunis, Boulifa, 7100
Nejmeddine Ouerghi, Ph.D, +21625300232, najm_ouerghi@hotmail.com
About this study
Official title: 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
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.
Read more
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.
Read the 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.
- Conditions
- Postmenopausal Women, Overweight, Obesity
- Being tested
- Whole-body electromyostimulation (WB-EMS) training, Supervised exercise without whole-body electromyostimulation (WB-EMS)
- Keywords
- Whole-body electromyostimulation (WB-EMS), Postmenopausal women, Cardiometabolic health, Quality of life, Electromyostimulation, Obesity, 6-minute walk test
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole-body electromyostimulation (WB-EMS) trainingOther
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Supervised exercise without whole-body electromyostimulation (WB-EMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index (BMI)
BMI calculated as weight (kg) divided by height squared (m²)
Measured: 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 %.
Measured: 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.
Measured: 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.
Measured: Baseline and after the 16 weeks of the training intervention
Total Cholesterol
Plasma total cholesterol concentration (mg/dL).
Measured: Baseline and after the 16 weeks of the training intervention.
Triglycerides
Plasma triglyceride concentration (mg/dL)
Measured: Baseline and after the 16 weeks of the training intervention
High-Density Lipoprotein (HDL) Cholesterol
Plasma HDL cholesterol concentration (mg/dL)
Measured: Baseline and after the 16 weeks of the training intervention
Low-Density Lipoprotein (LDL) Cholesterol
Plasma LDL cholesterol concentration (mg/dL)
Measured: 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
Measured: 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.
Measured: Baseline and after the 16 weeks of the training intervention
Secondary outcomes (4)
Fasting glucose
Fasting plasma glucose concentration (mmol/L).
Measured: Baseline and after the 16 weeks of the training intervention
Blood Pressure (Systolic and Diastolic)
Measured using an automated arm cuff (Omron BP652)
Measured: Baseline and after the 16 weeks of the training intervention
Resting Heart Rate
Measured using automated device (Omron BP652)
Measured: Baseline and after the 16 weeks of the training intervention
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
Measured: Baseline and after the 16 weeks of the training intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start20 Sep 2026 (estimated)
- Primary completion27 Jan 2027 (estimated)
- Study completion27 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- High Institute of Sports and Physical Education of Kef
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nejmeddine Ouerghi, High Institute of Sports and Physical Education of Kef
- Investigators
- Nejmeddine Ouerghi, Ph.D, Principal investigator, Research Unit "Sport Sciences, Health and Movement"(UR22JS01) High Institute of Sport and Physical Education of Kef, University of Jendouba, 7100 Kef, Tunisia.Nejmeddine Ouerghi, Principal investigator, Research Unit "Sport Sciences, Health and Movement"(UR22JS01) High Institute of Sport and Physical Education of Kef, University of Jendouba, 7100 Kef, Tunisia.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07826754
- Sponsor's protocol ID
- AS_WB-EMS_Women
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: For confidentiality reasons, all data from this study are available upon request
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07826754
- Acronym / sponsor ID
- AS_WB-EMS_Women
- Conditions
- Postmenopausal Women, Overweight, Obesity
- Keywords
- Whole-body electromyostimulation (WB-EMS), Postmenopausal women, Cardiometabolic health, Quality of life, Electromyostimulation, Obesity, 6-minute walk test
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- High Institute of Sports and Physical Education of KefUniversity, hospital or other
- Study start
- 20 Sep 2026 (estimated)
- Primary completion
- 27 Jan 2027 (estimated)
- Study completion
- 27 Jan 2027 (estimated)
- First posted
- 17 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WB-EMS group | Experimental | Other: Whole-body electromyostimulation (WB-EMS) trainingParticipants 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. |
| Control group | Active comparator | Behavioral: Supervised exercise without whole-body electromyostimulation (WB-EMS)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. |
Who may qualify
- Ages
- 48 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Body mass index (BMI) ≥25 kg/m²
- Age 48-60 years
- Postmenopausal status, defined as amenorrhea for >12 consecutive months
- Stable eating habits
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole-body electromyostimulation (WB-EMS) trainingParticipants 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. | Other | WB-EMS group |
| Supervised 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. | Behavioural | Control group |
Primary outcome
Body Mass Index (BMI)
Time frame: Baseline and after the 16 weeks of the training intervention.
BMI calculated as weight (kg) divided by height squared (m²)
Body fat percentage
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 %.
Waist circumference
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.
Hip circumference
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.
Total Cholesterol
Time frame: Baseline and after the 16 weeks of the training intervention.
Plasma total cholesterol concentration (mg/dL).
Triglycerides
Time frame: Baseline and after the 16 weeks of the training intervention
Plasma triglyceride concentration (mg/dL)
High-Density Lipoprotein (HDL) Cholesterol
Time frame: Baseline and after the 16 weeks of the training intervention
Plasma HDL cholesterol concentration (mg/dL)
Low-Density Lipoprotein (LDL) Cholesterol
Time frame: Baseline and after the 16 weeks of the training intervention.
Plasma LDL cholesterol concentration (mg/dL)
6-Minute Walk Test (6MWT) Distance
Time frame: 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)
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.
4 secondary outcomes
Fasting glucose
Time frame: Baseline and after the 16 weeks of the training intervention
Blood Pressure (Systolic and Diastolic)
Time frame: Baseline and after the 16 weeks of the training intervention
Resting Heart Rate
Time frame: Baseline and after the 16 weeks of the training intervention
Satisfaction with life
Time frame: Baseline and after the 16 weeks of the training intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No. For confidentiality reasons, all data from this study are available upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nejmeddine Ouerghi, Ph.D principal investigator
Research Unit "Sport Sciences, Health and Movement"(UR22JS01) High Institute of Sport and Physical Education of Kef, University of Jendouba, 7100 Kef, Tunisia.
Nejmeddine Ouerghi principal investigator
Research Unit "Sport Sciences, Health and Movement"(UR22JS01) High Institute of Sport and Physical Education of Kef, University of Jendouba, 7100 Kef, Tunisia.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole-body electromyostimulation (WB-EMS) training and Supervised exercise without whole-body electromyostimulation (WB-EMS) in people with Postmenopausal Women and Overweight, run by High Institute of Sports and Physical Education of Kef at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nejmeddine Ouerghi, Ph.D (+21625300232, najm_ouerghi@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Mass Index (BMI) (time frame: Baseline and after the 16 weeks of the training intervention.). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.