CClinicalTrials.gg
Status unknownNCT03710447Updated Oct 18, 2018

Effects of Concurrent HIIT and WB-EMS Exercise on the Cardiometabolic Risk Profile in Obese Individuals

An interventional study of HIIT + WB-EMS and WB-EMS + HIIT in Overweight and Obesity and Metabolic Syndrome, sponsored by University of Erlangen-Nürnberg Medical School. Status unknown at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-18.

Sponsored by University of Erlangen-Nürnberg Medical School · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The main purpose of this study is to compare the impact of concurrent high-intensity interval training (HIIT) and whole-body electromyostimulation exercise (WB-EMS) or low-volume conventional strength training (CST) on the cardiometabolic risk profile, overall physical fitness (cardiorespiratory fitness and muscular strength), body composition, inflammatory markers and subjective health outcomes after a 12-week intervention trial in overweight individuals at increased cardiometabolic risk. Furthermore, this study aims to investigate the influence of intra-session exercise order on all outcomes.

02

Conditions studied

  • Overweight and Obesity
  • Metabolic Syndrome

Keywords

  • Cardiometabolic Health
  • Cardiorespiratory Fitness
  • Muscular Strength
  • Body Composition
  • Inflammation
  • Aerobic Exercise
  • Resistance Exercise
03

In context

Overweight

3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.

This study's planned enrollment of 100 is above the median of 73 across 3,175 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

University of Erlangen-Nürnberg Medical School is the lead sponsor of 267 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Body Mass Index >25
  • presence of at least 2 cardiometabolic risk factors

Exclusion criteria

Exclusion Criteria:

  • 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
  • malignant disease
  • Electronic implants (defibrillator, pacemaker)
  • Persons in mental hospitals by order of authorities or jurisdiction
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    HIIT + WB-EMS

    High-intensity interval training (HIIT) combined with whole-body electromyostimulation (WB-EMS) Sequence of application: HIIT - WB-EMS

    Other: HIIT + WB-EMS

  • Experimental
    WB-EMS + HIIT

    Whole-body electromyostimulation (WB-EMS) combined with High-intensity interval training (HIIT) Sequence of application: WB-EMS - HIIT

    Other: WB-EMS + HIIT

  • Experimental
    HIIT + CST

    High-intensity interval training (HIIT) combined with conventional low-volume strength training (CST) Sequence of application: HIIT - CST

    Other: HIIT + CST

  • Experimental
    CST + HIIT

    Conventional low-volume strength training (CST) combined with high-intensity interval training (HIIT) Sequence of application: CST - HIIT

    Other: CST + HIIT

Interventions

  • OtherHIIT + WB-EMS

    12-week supervised exercise program consisting of ergometer-based high-intensity interval training (HIIT) and whole-body electromyostimulation (WB-EMS). HIIT: 5x1 min at 85-95% HRmax divided by low-intensity recovery periods. WB-EMS: Simulanteous stimulation of all major muscle groups with dedicated individual intensity. 2 exercise sessions per week. Order of application: HIIT - WB-EMS. Additionally, participants receive individualized nutritional counseling.

  • OtherWB-EMS + HIIT

    12-week supervised exercise program consisting of whole-body electromyostimulation (WB-EMS) and ergometer-based high-intensity interval training (HIIT). WB-EMS: Simulanteous stimulation of all major muscle groups with dedicated individual intensity. HIIT: 5x1 min at 85-95% HRmax divided by low-intensity recovery periods. 2 exercise sessions per week. Order of application: WB-EMS - HIIT. Additionally, participants receive individualized nutritional counseling.

  • OtherHIIT + CST

    12-week supervised exercise program consisting of ergometer-based high-intensity interval training (HIIT) and conventional low-volume strength training(CST). HIIT: 5x1 min at 85-95% HRmax divided by low-intensity recovery periods. CST: Conventional 1-set strength training using weight machines to train all major muscle groups with an individual intensity corresponding to 70-80% of one repetition maximum. 2 exercise sessions per week. Order of application: HIIT - CST. Additionally, participants receive individualized nutritional counseling.

  • OtherCST + HIIT

    12-week supervised exercise program consisting of conventional low-volume strength training(CST) and ergometer-based high-intensity interval training (HIIT). CST: Conventional 1-set strength training using weight machines to train all major muscle groups with an individual intensity corresponding to 70-80% of one repetition maximum. HIIT: 5x1 min at 85-95% HRmax divided by low-intensity recovery periods. 2 exercise sessions per week. Order of application: CST - HIIT. Additionally, participants receive individualized nutritional counseling.

06

What researchers measure

Primary outcomes

  1. Change in 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.

    Time frame: 12 weeks

  2. Change in overall Physical Fitness Score (PFS)

    PFS is calculated from VO2max and 1 Repmax values of 5 major muscle Groups.

    Time frame: 12 weeks

Secondary outcomes

  1. Change in Body Composition

    Muscle mass, fat mass and body water will be measured by Bioelectrical Impedance Analysis (BIA)

    Time frame: 12 weeks

  2. Change in HOMA-IR

    Insulin resistance will be estimated using homeostasis model assessment index (HOMA)

    Time frame: 12 week

  3. Change Inflammation status

    Inflammation will be assessed by measuring levels of inflammatory blood markers (CRP, inflammatory cytokines)

    Time frame: 12 weeks

  4. Change in Health-related quality of life

    Health-related quality of life will be assessed by using the standardized and validated EQ-5D-5L Questionnaire

    Time frame: 12 weeks

  5. Change in Pain scores

    Pain scores will be assessed by using the standardized and validated Chronic Pain Grade Questionnaire (CPGQ)

    Time frame: 12 weeks

  6. Change in Perceived stress

    Perceived stress will be assessed by using the standardized and validated Perceived Stress Questionnaire (PSQ)

    Time frame: 12 weeks

  7. Change Subjective work ability

    Subjective work ability will be assessed by using the standardized and validated Work Ability Index Questionnaire (WAI)

    Time frame: 12 weeks

07

Study locations

1 of 1 sites recruiting
  • Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg
    Erlangen, 91052, Germany
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 18, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03710447
Lead sponsor
University of Erlangen-Nürnberg Medical School
Responsible party
Sponsor
First posted
Oct 18, 2018
Start date
Oct 15, 2018 (estimated)
Primary completion
Oct 30, 2021 (estimated)
Completion
Oct 30, 2021 (estimated)
Last update
Oct 18, 2018

Study contacts

Dejan Reljic, Dr.
Contact
dejan.reljic@uk-erlangen.de
+49 9131 8545218
Yurdaguel Zopf, Prof.
Contact
yurdaguel.zopf@uk-erlangen.de
+49 9131 8545218
Dejan Reljic, Dr.
principal investigator · University Erlangen Nuremberg Medical School
Yurdaguel Zopf, Prof.
principal investigator · University Erlangen Nuremberg Medical School

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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