Overweight and ObesityNCT03710447
Effects of Concurrent HIIT and WB-EMS Exercise on the Cardiometabolic Risk Profile in Obese Individuals
A study testing HIIT + WB-EMS, WB-EMS + HIIT and HIIT + CST 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 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… 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?
- HIIT + WB-EMS, WB-EMS + HIIT and HIIT + CST
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 15 Oct 2018to 30 Oct 2021
- 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 9Show fewer
- malignant disease
- 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, Friedrich-Alexander-University Erlangen-Nuremberg
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: Effects of Concurrent High-Intensity Interval Training and Whole-Body Electromyostimulation on the Cardiometabolic Risk Profile in Obese Individuals at Increased Risk for the Metabolic Syndrome
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.
- Conditions
- Overweight and Obesity, Metabolic Syndrome
- Being tested
- HIIT + WB-EMS, WB-EMS + HIIT, HIIT + CST, CST + HIIT
- Keywords
- Cardiometabolic Health, Cardiorespiratory Fitness, Muscular Strength, Body Composition, Inflammation, Aerobic Exercise, Resistance Exercise
- Medical subject headings
- Overweight, Obesity, Metabolic Syndrome, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIIT + WB-EMSOther
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.
WB-EMS + HIITOther
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.
HIIT + CSTOther
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.
CST + HIITOther
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.
| Study group | Role | What they receive |
|---|---|---|
| HIIT + WB-EMS | Experimental | High-intensity interval training (HIIT) combined with whole-body electromyostimulation (WB-EMS) Sequence of application: HIIT - WB-EMS Receives: Other: HIIT + WB-EMS |
| WB-EMS + HIIT | Experimental | Whole-body electromyostimulation (WB-EMS) combined with High-intensity interval training (HIIT) Sequence of application: WB-EMS - HIIT Receives: Other: WB-EMS + HIIT |
| HIIT + CST | Experimental | High-intensity interval training (HIIT) combined with conventional low-volume strength training (CST) Sequence of application: HIIT - CST Receives: Other: HIIT + CST |
| CST + HIIT | Experimental | Conventional low-volume strength training (CST) combined with high-intensity interval training (HIIT) Sequence of application: CST - HIIT Receives: Other: CST + HIIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Change in overall Physical Fitness Score (PFS)
PFS is calculated from VO2max and 1 Repmax values of 5 major muscle Groups.
Measured: 12 weeks
Secondary outcomes (7)
Change in Body Composition
Muscle mass, fat mass and body water will be measured by Bioelectrical Impedance Analysis (BIA)
Measured: 12 weeks
Change in HOMA-IR
Insulin resistance will be estimated using homeostasis model assessment index (HOMA)
Measured: 12 week
Change Inflammation status
Inflammation will be assessed by measuring levels of inflammatory blood markers (CRP, inflammatory cytokines)
Measured: 12 weeks
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
Measured: 12 weeks
Change in Pain scores
Pain scores will be assessed by using the standardized and validated Chronic Pain Grade Questionnaire (CPGQ)
Measured: 12 weeks
Change in Perceived stress
Perceived stress will be assessed by using the standardized and validated Perceived Stress Questionnaire (PSQ)
Measured: 12 weeks
Change Subjective work ability
Subjective work ability will be assessed by using the standardized and validated Work Ability Index Questionnaire (WAI)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2018
- Study start15 Oct 2018 (estimated)
- Primary completion30 Oct 2021 (estimated)
- Study completion30 Oct 2021 (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 Assignment 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
- NCT03710447
- Sponsor's protocol ID
- COMBI-Study
- Status last verified
- Oct 2018
- First submitted
- 1 Jul 2018
- Last updated
- 18 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 18 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Concurrent High-Intensity Interval Training and Whole-Body Electromyostimulation on the Cardiometabolic Risk Profile in Obese Individuals at Increased Risk for the Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT03710447
- Acronym / sponsor ID
- COMBI-Study
- Conditions
- Overweight and Obesity, Metabolic Syndrome
- Keywords
- Cardiometabolic Health, Cardiorespiratory Fitness, Muscular Strength, Body Composition, Inflammation, Aerobic Exercise, Resistance Exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- 15 Oct 2018 (estimated)
- Primary completion
- 30 Oct 2021 (estimated)
- Study completion
- 30 Oct 2021 (estimated)
- First posted
- 18 Oct 2018 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Parallel Assignment parallel-group, randomized-controlled study
| Arm | Type | Receives |
|---|---|---|
| HIIT + WB-EMS | Experimental | Other: HIIT + WB-EMSHigh-intensity interval training (HIIT) combined with whole-body electromyostimulation (WB-EMS) Sequence of application: HIIT - WB-EMS |
| WB-EMS + HIIT | Experimental | Other: WB-EMS + HIITWhole-body electromyostimulation (WB-EMS) combined with High-intensity interval training (HIIT) Sequence of application: WB-EMS - HIIT |
| HIIT + CST | Experimental | Other: HIIT + CSTHigh-intensity interval training (HIIT) combined with conventional low-volume strength training (CST) Sequence of application: HIIT - CST |
| CST + HIIT | Experimental | Other: CST + HIITConventional low-volume strength training (CST) combined with high-intensity interval training (HIIT) Sequence of application: CST - HIIT |
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 (9 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 |
|---|---|---|
| HIIT + WB-EMS12-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. | Other | HIIT + WB-EMS |
| WB-EMS + HIIT12-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. | Other | WB-EMS + HIIT |
| HIIT + CST12-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. | Other | HIIT + CST |
| CST + HIIT12-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. | Other | CST + HIIT |
Primary outcome
Change in Metabolic Syndrome Z-Score (MetS-Z-Score).
Time frame: 12 weeks
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.
Change in overall Physical Fitness Score (PFS)
Time frame: 12 weeks
PFS is calculated from VO2max and 1 Repmax values of 5 major muscle Groups.
7 secondary outcomes
Change in Body Composition
Time frame: 12 weeks
Change in HOMA-IR
Time frame: 12 week
Change Inflammation status
Time frame: 12 weeks
Change in Health-related quality of life
Time frame: 12 weeks
Change in Pain scores
Time frame: 12 weeks
Change in Perceived stress
Time frame: 12 weeks
Change Subjective work ability
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 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 HIIT + WB-EMS, WB-EMS + HIIT and HIIT + CST 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 9 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 18 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?
Change in Metabolic Syndrome Z-Score (MetS-Z-Score). (time frame: 12 weeks). The study lists 2 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 18 Oct 2018.