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

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.

Study Overview

• Status: Unknown
• Conditions: Metabolic Syndrome; Overweight and Obesity
• Intervention / Treatment: Other: HIIT + WB-EMS; Other: WB-EMS + HIIT; Other: HIIT + CST; Other: CST + HIIT

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.
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; 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.
Experimental: HIIT + CST; High-intensity interval training (HIIT) combined with conventional low-volume strength training (CST) Sequence of application: HIIT - CST	Other: HIIT + 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.
Experimental: CST + HIIT; Conventional low-volume strength training (CST) combined with high-intensity interval training (HIIT) Sequence of application: CST - HIIT	Other: CST + 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Erlangen-Nürnberg Medical School

Study record dates

Study Major Dates

• Study Start (Anticipated): October 15, 2018
• Primary Completion (Anticipated): October 30, 2021
• Study Completion (Anticipated): October 30, 2021

Study Registration Dates

• First Submitted: July 1, 2018
• First Submitted That Met QC Criteria: October 15, 2018
• First Posted (Actual): October 18, 2018

Study Record Updates

• Last Update Posted (Actual): October 18, 2018
• Last Update Submitted That Met QC Criteria: October 15, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Inflammation; Body Composition; Aerobic Exercise; Cardiorespiratory Fitness; Resistance Exercise; Cardiometabolic Health; Muscular Strength
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Body Weight; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome; Overweight
• Other Study ID Numbers: COMBI-Study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No