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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Metabolic Syndrome, Overweight and Obesity

Intervention / Treatment
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* Other: HIIT + WB-EMS
* Other: WB-EMS + HIIT
* Other: HIIT + CST
* Other: CST + HIIT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body Mass Index >25 presence of at least 2 cardiometabolic risk factors 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Assignment parallel-group, randomized-controlled study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HIIT + WB-EMS<br>High-intensity interval training (HIIT) combined with whole-body electromyostimulation (WB-EMS) Sequence of application: HIIT - WB-EMS | Other: HIIT + WB-EMS<br>* 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.<br>|
| Experimental: WB-EMS + HIIT<br>Whole-body electromyostimulation (WB-EMS) combined with High-intensity interval training (HIIT) Sequence of application: WB-EMS - HIIT | Other: WB-EMS + HIIT<br>* 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.<br>|
| Experimental: HIIT + CST<br>High-intensity interval training (HIIT) combined with conventional low-volume strength training (CST) Sequence of application: HIIT - CST | Other: HIIT + CST<br>* 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.<br>|
| Experimental: CST + HIIT<br>Conventional low-volume strength training (CST) combined with high-intensity interval training (HIIT) Sequence of application: CST - HIIT | Other: CST + HIIT<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 weeks | 
| Change in overall Physical Fitness Score (PFS) | PFS is calculated from VO2max and 1 Repmax values of 5 major muscle Groups. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Body Composition | Muscle mass, fat mass and body water will be measured by Bioelectrical Impedance Analysis (BIA) | 12 weeks | 
| Change in HOMA-IR | Insulin resistance will be estimated using homeostasis model assessment index (HOMA) | 12 week | 
| Change Inflammation status | Inflammation will be assessed by measuring levels of inflammatory blood markers (CRP, inflammatory cytokines) | 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 | 12 weeks | 
| Change in Pain scores | Pain scores will be assessed by using the standardized and validated Chronic Pain Grade Questionnaire (CPGQ) | 12 weeks | 
| Change in Perceived stress | Perceived stress will be assessed by using the standardized and validated Perceived Stress Questionnaire (PSQ) | 12 weeks | 
| Change Subjective work ability | Subjective work ability will be assessed by using the standardized and validated Work Ability Index Questionnaire (WAI) | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Body Composition, Aerobic Exercise, Resistance Exercise, Cardiorespiratory Fitness, Muscular Strength, Cardiometabolic Health, Inflammation