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

Metabolic Syndrome Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03710447
• Other study ID #: COMBI-Study
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2018
• Est. completion date: October 30, 2021

Study information

• Verified date: October 2018
• Source: University of Erlangen-Nürnberg Medical School
• Contact: Dejan Reljic, Dr.
• Phone: +49 9131 8545218
• Email: dejan.reljic[@]uk-erlangen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 30, 2021
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Overweight
• Overweight and Obesity
• Syndrome

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Germany	Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg	Erlangen

Sponsors (1)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change in overall Physical Fitness Score (PFS)	PFS is calculated from VO2max and 1 Repmax values of 5 major muscle Groups.	12 weeks
Secondary	Change in Body Composition	Muscle mass, fat mass and body water will be measured by Bioelectrical Impedance Analysis (BIA)	12 weeks
Secondary	Change in HOMA-IR	Insulin resistance will be estimated using homeostasis model assessment index (HOMA)	12 week
Secondary	Change Inflammation status	Inflammation will be assessed by measuring levels of inflammatory blood markers (CRP, inflammatory cytokines)	12 weeks
Secondary	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
Secondary	Change in Pain scores	Pain scores will be assessed by using the standardized and validated Chronic Pain Grade Questionnaire (CPGQ)	12 weeks
Secondary	Change in Perceived stress	Perceived stress will be assessed by using the standardized and validated Perceived Stress Questionnaire (PSQ)	12 weeks
Secondary	Change Subjective work ability	Subjective work ability will be assessed by using the standardized and validated Work Ability Index Questionnaire (WAI)	12 weeks