Overweight and ObesityEKAMNCT03306056
Whole-body Electromyostimulation Versus Conventional Low-volume Strength Training in Overweight Individuals
A study testing Standard Strength Training, Low-volume Strength Training and Whole-Body Electromyostimulation (WB-EMS) in people with Overweight and Obesity and Metabolic Syndrome, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
The main purpose of this study is to compare the effects of whole-body electromyostimulation versus a conventional low-volume strength-training program, each combined with an individualized, weight-reducing diet, on the cardiometabolic risk profile, muscle strength, body composition, inflammatory markers and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overweight and Obesity, Metabolic Syndrome
- What is being tested?
- Standard Strength Training, Low-volume Strength Training and Whole-Body Electromyostimulation (WB-EMS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 1 Nov 2017to 30 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body Mass Index >25
- presence of at least 2 cardiometabolic risk factors
Who cannot join
- Healthy persons or patients under age
- Overweight persons without any additional cardiometabolic risk factors
- Pregnancy, Lactation
- Psychological disorders, epilepsy, sever neurological disorders
- Participation in other exercise- or nutrition studies within the last 6 months
- acute cardiovascular disease
Show all 12Show fewer
- malignant disease
- Rheuma
- Intake of anabolic drugs,
- Skin injuries in the area of electrode placements
- Electronic implants (defibrillator, pacemaker)
- Persons in mental hospitals by order of authorities or jurisdiction
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports,
Erlangen, 91052
Dejan Reljic, Dr., +49 9131 8545218, dejan.reljic@uk-erlangen.de
Yurdaguel Zopf, Prof., +49 9131 8545218, yurdaguel.zopf@uk-erlangen.de
About this study
Official title: Comparison of the Effects of Whole-body Electromyostimulation Versus Conventional Low-volume Strength Training in Overweight Individuals at Increased Cardiometabolic Risk
The main purpose of this study is to compare the effects of whole-body electromyostimulation versus a conventional low-volume strength-training program, each combined with an individualized, weight-reducing diet, on the cardiometabolic risk profile, muscle strength, body composition, inflammatory markers and subjective health outcomes in overweight individuals at increased cardiometabolic risk.
- Conditions
- Overweight and Obesity, Metabolic Syndrome
- Being tested
- Control, Standard Strength Training, Low-volume Strength Training, Whole-Body Electromyostimulation (WB-EMS)
- Keywords
- Exercise, Strength Training, Health Promotion, Inflammation, Body Composition
- Medical subject headings
- Overweight, Obesity, Metabolic Syndrome, Motor Activity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
Individualized, weight-reducing nutritional therapy and counseling, during a study period of 12 weeks
Standard Strength TrainingOther
Procedures: Nutritional therapy (individualized, weight-reducing nutritional therapy and counseling) during a study period of 12 weeks combined with a standard strength training program:
- 5 strength training exercises (chest, upper/lower back, abdominals, legs)
- 3 sets per exercise
- time-effort per session: ~90 min
- 2 training sessions per week
- duration of exercise intervention: 12 weeks
Low-volume Strength TrainingOther
Procedures: Nutritional therapy (individualized, weight-reducing nutritional therapy and counseling) during a study period of 12 weeks combined a low-volume strength training program:
- 5 strength training exercises (chest, upper/lower back, abdominals, legs)
- 1 set per exercise
- time-effort per session: ~20 min
- 2 training sessions per week
- duration of exercise intervention: 12 weeks
Whole-Body Electromyostimulation (WB-EMS)Other
Procedures: Nutritional therapy (individualized, weight-reducing nutritional therapy and counseling) during a study period of 12 weeks combined with WB-EMS:
- time-effort per session: ~20 min
- duration of exercise intervention: 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | Nutritional therapy / no exercise Receives: Other: Control |
| Standard Strength Training | Experimental | Nutritional therapy combined with a Standard Strength Training program Receives: Other: Standard Strength Training |
| Low-volume Strength Training | Experimental | Nutritional therapy combined with a low-volume Strength Training program Receives: Other: Low-volume Strength Training |
| Whole-body Electromyostimulation | Experimental | Nutritional therapy combined with Whole-Body Electromyostimulation Receives: Other: Whole-Body Electromyostimulation (WB-EMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic Syndrome Z-Score (MetS-Z-Score)
MetS-Z-Score will be calculated from each individual's measures of waist circumference, mean arterial blood pressure, triglycerides, and HDL-cholesterol, based on equations specific to sex.
Measured: 12 weeks (baseline to 12 week follow-up assessment)
Secondary outcomes (8)
Muscle strength
Muscle strength of the five major muscle groups (chest, upper back, lower back, abdominals, legs) will be assessed by using specific strength-training devices (Butterfly, Pull-down, Hyperextension, Abdominal Crunch, Leg-Press)
Measured: 12 weeks (baseline to 12 week follow-up assessment)
Body Composition
Muscle mass, fat mass and body water will be measured by Bioelectrical Impedance Analysis (BIA)
Measured: 12 weeks (baseline to 12 week follow-up assessment)
Cardiorespiratory Fitness (CRF)
CRF will be assessed by measuring Maximum Oxygen uptake (VO2max)
Measured: 12 weeks (baseline to 12 week follow-up assessment)
Inflammation status
Inflammation will be assessed by measuring Levels of CRP and inflammatory cytokines and other inflammatory blood markers
Measured: 12 weeks (baseline to 12 week follow-up assessment)
Health-related quality of life
Health-related quality of life will be assessed by using the standardized and validated EQ-5D-5L Questionnaire
Measured: 12 weeks (baseline to 12 week follow-up assessment)
Pain scores
Pain scores will be assessed by using the standardized and validated Chronic Pain Grade Questionnaire (CPGQ)
Measured: 12 weeks (baseline to 12 week follow-up assessment)
Perceived stress
Perceived stress will be assessed by using the standardized and validated Perceived Stress Questionnaire (PSQ)
Measured: 12 weeks (baseline to 12 week follow-up assessment)
Subjective work ability
Subjective work ability will be assessed by using the standardized and validated Work Ability Index Questionnaire (WAI)
Measured: 12 weeks (baseline to 12 week follow-up assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2017
- Study start1 Nov 2017
- Primary completion30 Sep 2020 (estimated)
- Study completion30 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- parallel-group, randomized-controlled study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dejan Reljic, Dr., Principal investigator, University Erlangen Nuremberg Medical SchoolYurdaguel Zopf, Prof., Principal investigator, University Erlangen Nuremberg Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03306056
- Sponsor's protocol ID
- EKAM-Study
- Acronym
- EKAM
- Status last verified
- Oct 2018
- First submitted
- 27 Sep 2017
- Last updated
- 17 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Whole-body Electromyostimulation Versus Conventional Low-volume Strength Training in Overweight Individuals at Increased Cardiometabolic Risk
- ClinicalTrials.gov ID
- NCT03306056
- Acronym / sponsor ID
- EKAM / EKAM-Study
- Conditions
- Overweight and Obesity, Metabolic Syndrome
- Keywords
- Exercise, Strength Training, Health Promotion, Inflammation, Body Composition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 10 Oct 2017 (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 main purpose of this study is to compare the effects of whole-body electromyostimulation versus a conventional low-volume strength-training program, each combined with an individualized, weight-reducing diet, on the cardiometabolic risk profile, muscle strength, body composition, inflammatory markers and subjective health outcomes in overweight individuals at increased cardiometabolic risk.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- parallel-group, randomized-controlled study
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Other: ControlNutritional therapy / no exercise |
| Standard Strength Training | Experimental | Other: Standard Strength TrainingNutritional therapy combined with a Standard Strength Training program |
| Low-volume Strength Training | Experimental | Other: Low-volume Strength TrainingNutritional therapy combined with a low-volume Strength Training program |
| Whole-body Electromyostimulation | Experimental | Other: Whole-Body Electromyostimulation (WB-EMS)Nutritional therapy combined with Whole-Body Electromyostimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Body Mass Index >25
- presence of at least 2 cardiometabolic risk factors
Key exclusion criteria (12 listed)
- Healthy persons or patients under age
- Overweight persons without any additional cardiometabolic risk factors
- Pregnancy, Lactation
- Psychological disorders, epilepsy, sever neurological disorders
- Participation in other exercise- or nutrition studies within the last 6 months
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 |
|---|---|---|
| ControlIndividualized, weight-reducing nutritional therapy and counseling, during a study period of 12 weeks | Other | Control |
| Standard Strength TrainingProcedures: Nutritional therapy (individualized, weight-reducing nutritional therapy and counseling) during a study period of 12 weeks combined with a standard strength training program: * 5 strength training exercises (chest, upper/lower back, abdominals, legs) * 3 sets per exercise * time-effort per session: ~90 min * 2 training sessions per week * duration of exercise intervention: 12 weeks | Other | Standard Strength Training |
| Low-volume Strength TrainingProcedures: Nutritional therapy (individualized, weight-reducing nutritional therapy and counseling) during a study period of 12 weeks combined a low-volume strength training program: * 5 strength training exercises (chest, upper/lower back, abdominals, legs) * 1 set per exercise * time-effort per session: ~20 min * 2 training sessions per week * duration of exercise intervention: 12 weeks | Other | Low-volume Strength Training |
| Whole-Body Electromyostimulation (WB-EMS)Procedures: Nutritional therapy (individualized, weight-reducing nutritional therapy and counseling) during a study period of 12 weeks combined with WB-EMS: * time-effort per session: ~20 min * duration of exercise intervention: 12 weeks | Other | Whole-body Electromyostimulation |
Primary outcome
Metabolic Syndrome Z-Score (MetS-Z-Score)
Time frame: 12 weeks (baseline to 12 week follow-up assessment)
MetS-Z-Score will be calculated from each individual's measures of waist circumference, mean arterial blood pressure, triglycerides, and HDL-cholesterol, based on equations specific to sex.
8 secondary outcomes
Muscle strength
Time frame: 12 weeks (baseline to 12 week follow-up assessment)
Body Composition
Time frame: 12 weeks (baseline to 12 week follow-up assessment)
Cardiorespiratory Fitness (CRF)
Time frame: 12 weeks (baseline to 12 week follow-up assessment)
Inflammation status
Time frame: 12 weeks (baseline to 12 week follow-up assessment)
Health-related quality of life
Time frame: 12 weeks (baseline to 12 week follow-up assessment)
Pain scores
Time frame: 12 weeks (baseline to 12 week follow-up assessment)
Perceived stress
Time frame: 12 weeks (baseline to 12 week follow-up assessment)
Subjective work ability
Time frame: 12 weeks (baseline to 12 week follow-up assessment)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2018.
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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. This study is not recruiting at the moment.
Dejan Reljic, Dr. principal investigator
University Erlangen Nuremberg Medical School
Yurdaguel Zopf, Prof. principal investigator
University Erlangen Nuremberg Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Strength Training, Low-volume Strength Training and Whole-Body Electromyostimulation (WB-EMS) in people with Overweight and Obesity and Metabolic Syndrome, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
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 2 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 17 Oct 2018. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dejan Reljic, Dr. (+49 9131 8545218, dejan.reljic@uk-erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic Syndrome Z-Score (MetS-Z-Score) (time frame: 12 weeks (baseline to 12 week follow-up assessment)). 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 17 Oct 2018.